In this conversation, Lisa Bonebrake, Executive Director of Alport Syndrome Foundation, shares how her own family’s diagnostic journey led her into patient advocacy, and how ASF is now helping bring patients, clinicians, researchers, regulators, and industry to the same table. We discuss the rise of genetic testing, the growing Alport therapeutic pipeline, the role of patient registries and real-world data, and ASSENT, a global effort to support clearer surrogate endpoints and a more predictable regulatory pathway.

Nearly a century after Cecil Alport first described the condition, this rare kidney disease community may finally be entering a new chapter: clearer diagnosis, better data, and a path toward approved treatments. Thanks for being here with us.

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Q&A

Let’s start with you. Tell us about yourself and the work you do at Alport Syndrome Foundation.

Lisa: I’m grateful for the opportunity to highlight the work we do because this is not only a career for me, it’s also personal. I am an Alport syndrome patient, the parent of a patient, and the parent of a living donor.

At Alport Syndrome Foundation, our work is to provide education and support, collectively invest in research, and support industry in the mission to find potential treatments for Alport syndrome. That is the goal.

We have more than 11,000 members, primarily in the United States, but about 14% are outside the U.S. There are many countries that do not have a patient organization, so people often turn to us. That means using Google Translate and other tools, whatever it takes, to help patients gain an understanding of what it means to live with Alport syndrome.

Can you share more about your family’s story?

Lisa: My story is really not uncommon in our community. I hear it reflected back to me often when I meet other patients and families across the U.S. and around the world.

I grew up living with kidney disease and was misdiagnosed for more than 40 years. I had children not knowing I had a genetic kidney disease that I could pass down. My oldest son did not receive my genetic mutation, but my youngest son did, and he started having symptoms very early.

At the time, I was told, “He has what you have, and he’ll be just fine.” So we missed out on some years of treatment and monitoring. Then, when he developed hearing loss, which can also be caused by Alport syndrome, I was told it might be cancer, a brain tumor, or many other things.

Eventually, I went online and searched “boy,” “kidney disease,” and “hearing loss.” Articles about Alport syndrome came up. When I read through them, they really resonated with me. I thought, this must be the underlying cause of the kidney disease in my family.

It took a while to get someone to listen, but I finally found a nephrologist who was trained in both pediatric and adult nephrology, which is rare. We call her a “unicorn.” She took us seriously and was able to get us a biopsy right away. That was how Alport syndrome was first confirmed in our family.

Then we found Alport Syndrome Foundation. They treated us like family. They connected us to educational resources, experts in the disease, and research for the first time. That changed everything for my family.

I became involved as a volunteer, then joined the board, and later became staff. This work is deeply important to me, both personally and professionally.

What has changed the most since you first started learning about Alport syndrome?

Lisa: There have been some really big changes.

The first is genetic testing. Genetic testing has changed the game in Alport syndrome. When I first started this work, it was very rare for someone to join our free membership and report that they had a confirmed genetic diagnosis through genetic testing. Most people had been diagnosed by biopsy or were suspected to have Alport syndrome based on family history.

Now, more than 90% of our members who come on board each year self-report that they have had genetic testing and understand their genetic type. That is a tremendous sea change for research and for attracting companies into our space to think about treatments.

It has also shown us just how underdiagnosed Alport syndrome has been for so long. So many patients had stories of misdiagnosis. We were a community that was misunderstood and underdiagnosed. Genetic testing has changed that. The work Natera has done, with more than 14,000 individuals identified with genetic test results consistent with Alport syndrome, tells an important part of that story. People are being diagnosed more accurately and earlier, which also opens the door to potential earlier treatment.

The second major change is the therapeutic pipeline. When I started this work, there was one company with an Alport program and one clinical trial that started shortly after I began working with ASF. That drug was not approved, but at the time, it was one company.

Now there are six active clinical trials in our space that are either directly for Alport syndrome or include an Alport cohort within a basket study. There are also more therapies advancing toward the clinic quickly.

And the third big change is genetic therapies. Genetic therapies are moving toward the clinic very quickly. That is tremendously exciting and brand new for us.

What role does a patient organization play in helping companies develop new therapies?

Lisa: I don’t think the role of patient organizations on the front end of drug development is always clearly understood in the kidney ecosystem yet. But organizations like Alport Syndrome Foundation can be powerful conveners.

We are credible messengers of the patient voice. We have a contact database. We know where patients live. We understand where genetic testing is happening. We can get messages to patients so they are educated about their disease and about opportunities to participate in research.

We run our own patient registry. We have collectively invested as a community in a natural history study in partnership with NEPTUNE, a research consortium in the kidney space. That allows us to help bring patient data and the patient voice into the research process.

Just as importantly, we help make sure patients are protected, their privacy is respected, and their perspectives are heard in drug development. As a convener, we work with regulators, genetic counselors, researchers, clinicians, industry, and patients.

That role matters. We can help companies understand the patient experience quickly. For example, we offer patient listening sessions at no cost. A company can come to us and say, “We’re developing this protocol. How will patients see it? Will this work for them? Do they have concerns? Does it fit their lifestyle?”

We can bring patients together in person or virtually, and pharma has told us those sessions are tremendously helpful. The goal is to help companies invest wisely in Alport syndrome and use their dollars and intellectual resources well.

It sounds like a win for both sides. Who else needs to be at the table?

Lisa: There are a lot of people we need at the table. We need industry. We need genetic testing. We need qualified genetic counselors who can help patients understand their genetic test results, what those results mean for their own kidney disease risk, and who else in their family may be at risk.

We need regulators, and I’m grateful to say the FDA has been working with us as a partner in this space.1

We need everybody at the table.

How significant is genetic testing to where Alport syndrome goes from here?

Lisa: It is incredibly significant. Patients come to genetic testing in different ways. Some have a suspected diagnosis and come to us directly asking, “How do I get genetic testing?” We provide options and information about their right to testing, what they might learn, how it could shape their treatment plan, and what it could mean for their family.

We are also seeing more people learn about Alport syndrome during family planning. They may use a test like Natera’s Horizon program to understand what risks may exist in their family. So we are seeing more people come to us very early, even before they have children.2

Others come through nephrology. They may have hematuria or proteinuria and not know why. A clinician who understands the role of genetic testing may order a test, and that is becoming more common. Genetic testing is now part of the KDIGO guidelines for patients with certain symptoms, which is an important change.

In our experience, pediatric nephrologists embraced genetic testing a little faster than adult nephrologists, although that is beginning to change. They have really been on the front lines.

We also hope more clinicians will refer patients to Alport Syndrome Foundation when they are diagnosed, because people need support, education, and community. Everything ASF does is free.

How does ASF support patients across the diagnostic and care journey?

Lisa: We have information to help people understand their right to genetic testing. We also backchannel with some companies if patients are struggling to pay for testing, because it is so important for families to understand their diagnosis, get the right treatment, and understand their risks.

We also have a large support community. For example, we have an online support group that is only open to patients and caregivers. It has more than 6,100 people and is moderated by ASF staff and volunteers 24/7.

People are exchanging real experiences in real time and helping each other through this. I find it tremendously valuable. It has helped my own family, and I see it help so many others.

You mentioned registries and longitudinal data. What does that work look like, and why does it matter?

Lisa: These days, data is everything, particularly in a rare disease that is not well understood. Alport syndrome has different genetic types: autosomal recessive, autosomal dominant, X-linked, and digenic. It is also a complex disease. It affects the kidneys, but it can also affect the ears, eyes, lungs, and heart. So we need data to understand the wide variety of patient experiences, the risk of kidney failure across genetic types and variants, and the other symptoms that come with the disease.3

ASF also sponsors its own registry, which was established in 2023. It includes self-reported data, but patients can also upload genetic test results, audiograms, lab reports, family history, medications, doses, and information about side effects. Genetic test results are verified by medical genetics specialists on the back end, so researchers and pharma can trust that data.

That will become especially important if new treatments are approved, because we will be able to understand how patients are using them in the real world.

One of the biggest challenges is that registries are often siloed, and it is difficult to share data. This is where a patient organization can come in and cross borders in ways that others may not be able to.

We are working with registries around the world to collect, harmonize, and analyze data in a public-private partnership with the FDA. The goal is to inform the use of surrogate endpoints in Alport syndrome. We are starting with eGFR and proteinuria, so those measures are better understood and could potentially support a clearer regulatory pathway. With a rare disease, there is not one country or one database with enough data in one place. You need global collaboration. That is where we can help convene.

How common is Alport syndrome?

Lisa: I wish I could give a definitive answer, but prevalence is still a bit of a mystery. The studies have limitations, and the estimates have changed over time.

What we are finding through increased genetic testing in the U.S. and places like the U.K. is that Alport syndrome is far more common than we ever would have imagined. We are proving that, even if we do not yet know the exact prevalence.

A few years ago, Dr. Alexander Chang and colleagues conducted a study at Geisinger Health. Dr. Chang is now co-chair of the international data collection project we are working on called ASSENT. His study found that X-linked Alport syndrome had a prevalence of about 1 in every 2,000 individuals in that health system.

What we are also finding is that autosomal dominant Alport syndrome is far more common than that. Some studies suggest autosomal dominant Alport genetics may be present in as many as 1 in 100 births. But the experience is highly variable. Some people may never have symptoms, never be tested, and never experience kidney disease progression.

What we need to understand is why some people with autosomal dominant Alport syndrome have the full Alport experience and progress to kidney failure. Is it the variant? Is it environmental factors? We do not know yet. That is another reason why collecting this data is so important.

Can you tell us more about ASSENT and the work to build a clearer regulatory pathway?

Lisa: ASSENT stands for Alport Syndrome Surrogate Endpoint Network. It came out of a research and regulatory workshop that Alport Syndrome Foundation convened in May 2025. We brought together members of the FDA, representatives from NIH, and about 30 of the world’s leading experts in Alport syndrome, including researchers and clinicians who see and treat many Alport patients.

The question was: how do we build a clearer regulatory pathway for a growing pipeline of potential treatments in Alport syndrome?

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What we realized is that the human data had not yet been analyzed in a way that could inform surrogate endpoints. We need to better understand the biomarkers that predict risk of kidney failure in Alport syndrome. You do not want trials that have to last for years and years, waiting for people to progress to kidney failure. You want to understand risk earlier.

That is where ASSENT came from. Someone needed to collect and analyze the data, and ASF was encouraged to be the convener because we had already shown we could bring global experts and regulators together.

The work is being done by extraordinary volunteers: biostatisticians, renal endpoint experts, clinicians, and researchers. We now have a data coordinating center, and registries and dataset holders from around the world have signed on to participate.

What has been powerful is hearing clinicians say they are volunteering because they are tired of having no approved treatments for their Alport patients, many of whom progress to kidney failure early in life. This gives them a meaningful way to help shape a new path toward potential treatments.

What is the timeline for ASSENT?

Lisa: We had our first meeting with FDA liaisons in December 2025 to share the statistical analysis plan. They graciously gave us a five-hour in-person meeting on the FDA campus, and we came away with agreement that the roadmap made sense. Since then, we have been identifying data sources, getting participants on board, and refining the statistical analysis plan.

Our next in-person meeting with the volunteers, committee members, and FDA liaisons is in June 2026 in Washington, DC. The goal is to review the initial analysis from several registries, work through remaining questions, and finalize the statistical analysis plan.

Then, at the International Workshop on Alport Syndrome in Budapest on September 5, we will hold a workshop focused solely on ASSENT. We will share the first set of analyses and give everyone a chance to ask questions, provide feedback, and think through the findings. The hope is to complete the analysis early next year. We have to follow the science. We do not know exactly where it will lead, but we hope it will bring real clarity.

How can patients participate in this effort?

Lisa: Patients around the world are participating by contributing their data to patient registries, including the ASF Alport Patient Registry here in the U.S.

We try to keep patients informed through our monthly e-newsletter, which goes out to free members, clinicians, researchers, and industry members. We also share updates through social media and on our website, where we have information and a video about the project. Right now, the main way patients are involved is by contributing their data through registries.

What are your top priorities for ASF over the next year or two?

Lisa: Next year is a big milestone year for us. In 2027, it will be 100 years since Cecil Alport published his paper describing families with kidney failure early in life and hearing loss. It will also be 20 years since Alport Syndrome Foundation was established.

So it is a chance to look back at the progress we have made, but also to look ahead. One major priority is completing this international data collection project, which we hope will inform the use of surrogate endpoints and help open a clearer regulatory pathway for Alport syndrome. We will be doing a lot of celebrating next year, but what I really hope is that 2027 and 2028 bring the first approved treatments for Alport syndrome. That would be fantastic.

Another major priority is preparing for genetic therapies. These are advancing quickly, and there is a lot of work to do. For example, we need to better understand the role of biopsies in adults and pediatrics, and what they may contribute to understanding treatment effect.

Not long ago, we thought genetic therapy might be science fiction for Alport syndrome. That is no longer the case.

Final thoughts? What do you want people to take away from this conversation?

Lisa: I want everybody in the nephrology space to understand the role patient organizations like Alport Syndrome Foundation are playing on the front end of drug development.

We can bring real value as a partner. We are part of the data ecosystem. We help patients understand their right to participate in research. We connect companies with clinicians, trial sites, and thought leaders. We provide real-time patient feedback on protocols. And we help make sure companies are investing wisely in Alport syndrome.

This work is also about patient empowerment. Patients want to be involved. We know we can bring value through our lived experience. We are experts in our disease in a different way, and those insights matter.

So I would say to anyone in nephrology, whether you are a researcher, clinician, genetic counselor, policymaker, or industry leader: come to us early. Most of our research funds come from patients, families, caregivers, and friends who love them. This is an important role we have to play, and we take it seriously.

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We’d love to hear from you. What stood out from Lisa’s story, and what should more people understand about Alport syndrome, genetic testing, and the role patients and families can play in advancing care?

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The backdrop is straightforward. Healthcare spending continues to climb, but the fastest growth is increasingly concentrated in specialty care. Six specialties—orthopedics, oncology, cardiology, women’s health, behavioral health, and nephrology—now account for 38% of Medicare and commercial medical spending and touch patients responsible for more than two-thirds of total healthcare expenditures. Between 2020 and 2023, spending across those specialties grew 35% faster than the rest of the market.

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That matters because the payment model shapes the care model. In fee-for-service, specialty care is largely paid based on visits, tests, procedures, and activity. In value-based care, payment begins to shift toward outcomes: keeping people healthier, avoiding preventable complications, and managing total cost of care. The hard part is that not every specialist is moving through the same model at the same time: a nephrologist may be accountable for a patient’s total cost of care while another specialist treating the same patient is still paid primarily through services and procedures.

Primary care has already moved much further in that direction, with more than half of Medicare beneficiaries now receiving care through some form of value-based arrangement. Specialty care remains earlier in the transition. McKinsey estimated that 28% of nephrology patient lives were managed under risk-bearing value-based contracts in 2023, compared with roughly 20% in orthopedics and 5% or less across several other high-spend specialties. Even at those levels, nephrology stood out as the clear leader among specialty categories. That leadership position is one reason kidney care has become an important proving ground for what accountable specialty care can achieve, especially as more kidney disease is identified and managed earlier in primary care.

What we’re seeing

Observation 1: The accountability gap in kidney care is closing faster than most investors realize. Since those 2023 estimates were published, value-based care adoption in nephrology has continued to expand. Based on Signals research, we estimate that approximately 30-35% of kidney patients are now managed under total cost of care arrangements, where organizations take responsibility for the broader cost and quality of care over time. CMS has made specialty value-based care expansion a priority, and new payment models are pulling more nephrology lives into risk-bearing structures. The infrastructure to manage those lives, including companies like Monogram, Strive, and Somatus, has absorbed nearly $1.6 billion in capital. That investment has demonstrated what is possible, while also surfacing where the hard problems remain: earlier identification, better monitoring, provider-level support, and more scalable patient-level support across multiple conditions.

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Observation 2: The $608B combined cardio-kidney total cost of care represents one of the largest addressable pools in specialty medicine. Cardiology represents roughly $467 billion in annual total cost of care, while nephrology represents another $141 billion. These are often treated as separate markets, but they are frequently the same patient population viewed from different clinical entry points. That creates real friction in today’s payment system. A nephrologist may be working under a total-cost-of-care model, while the cardiologist managing the same patient is still paid largely through fee-for-service. One part of the system is rewarded for preventing avoidable complications, while another is still paid around visits, tests, and procedures. Cardio-kidney-metabolic disease is already converging clinically. The payment model has not fully caught up. The organizations that figure out how to manage that risk under a more connected model are building infrastructure for one of the largest accountable spend pools in American healthcare.

Observation 3: The investment thesis follows the spend, not the science. Nearly $10 billion has been deployed into platforms managing kidney and broader cardiometabolic populations at scale, and exits are beginning to emerge. Two digital health IPOs in 2025 reinforce the point: when companies can manage large populations, align with reimbursement, and show a path to durable outcomes, the market pays attention.1 As more specialty care moves into risk-bearing arrangements, the hard problems shift into execution: earlier diagnosis, continuous monitoring, patient engagement, AI-enabled workflows, and care delivery infrastructure. For early-stage investors, the opportunity is to build the enabling companies that help accountable platforms perform.

Where capital goes next

Kidney care has already done much of the hard work. Over the past decade, the field has served as a testing ground for new payment models, care delivery approaches, and accountability structures. Along the way, it has built infrastructure, attracted capital, and demonstrated what coordinated care can achieve at scale. Many of the same forces are now beginning to reach the rest of specialty medicine.

For investors, the opportunity increasingly lies in the enabling layer: the diagnostics, data infrastructure, AI tools, monitoring platforms, and workflow systems that make accountable care possible. The trillion-dollar shift we described in Part 1 is becoming market structure. The organizations building that foundation will help shape how the next decade of healthcare is delivered.

This series started with a simple observation: the kidney is an early signal for where medicine is heading. Over the coming months, we will continue exploring that idea alongside the founders, clinicians, researchers, operators, and industry leaders building the future of kidney and cardiometabolic care.

If you are building, investing, researching, or working on these challenges, we would love to hear from you.

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Janis Naeve and Tim Fitzpatrick are Co-Founding Partners of Bright Frontier Capital, a new thesis-driven venture fund designed to shape the future of kidney and cardiometabolic health.

Kidney data infrastructure is unusually hard to build because kidney disease is not one disease. It is a collection of overlapping conditions that can look similar in clinic but behave very differently biologically. Two people may carry the same broad diagnosis, follow similar care pathways, and still progress for different reasons, at different speeds, and in response to different underlying mechanisms.

That is what makes kidney research so difficult. It is also what makes better research infrastructure so important. The field has never lacked important questions. Why does one person’s kidney disease progress rapidly while another’s remains stable? Why do some treatments work for some people, but not for others? Why are so many people still diagnosed too late, treated too bluntly, or left with options that have changed too little over decades?

Often, the problem is not the quality of the question. It is that the pieces needed to answer it are scattered. A blood sample may sit in one place. Biopsy data in another. Clinical history somewhere else. Patient-reported outcomes may never be connected at all. For researchers, that fragmentation makes important questions harder to answer. For patients, it means progress arrives later than it should.

NURTuRE was created to help solve that problem. Led by Kidney Research UK, NURTuRE is a UK-wide research platform that brings high-quality biological samples together with carefully governed health and research data. Its goal is simple: make it easier for researchers to ask better questions about kidney disease and reach better answers faster.

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At its foundation are nearly 4,000 people with chronic kidney disease and idiopathic nephrotic syndrome who contributed blood, urine, and detailed clinical information. Their participation created something larger than a collection of samples. It created a platform for discovery, linking serum, plasma, urine, longitudinal clinical data, quality-of-life data, biopsy information, biomarkers, histopathology, whole exome sequencing, and growing multi-omic datasets.

That matters because the most useful kidney data are rarely just numbers in a spreadsheet. A researcher trying to understand why two patients with similar eGFR trajectories have very different outcomes may need more than lab values. They may need tissue, blood, urine, imaging, pathology, genomics, medication history, comorbidities, patient-reported outcomes, and the clinical context that explains how a person’s disease changes over years. Bringing those layers together safely, ethically, and usefully is the work of infrastructure.

Two Cohorts

Two NURTuRE cohorts show why this matters. In NURTuRE-CKD, researchers enrolled 2,996 people with CKD from 16 nephrology centers across England, Scotland, and Wales, with clinical outcomes being collected over 15 years through UK Renal Registry linkage. The cohort was built to improve risk prediction and help researchers investigate the underlying mechanisms that drive clinically important outcomes in CKD.1

The NURTuRE-INS cohort adds a different kind of depth. Idiopathic nephrotic syndrome can vary widely from patient to patient, and existing classification systems are increasingly seen as too blunt for the biology underneath. That cohort brings together high-quality biosamples and detailed clinical data from 739 INS patients across the UK, creating a foundation for researchers to study disease mechanisms more directly and develop better ways to subgroup patients.2

Across CKD and INS, NURTuRE shows the promise of shared infrastructure: not just more data, but better ways to understand which patients are at risk, which mechanisms are driving disease, and which treatments may be right for which people.

A Broader Movement

NURTuRE also sits in conversation with major U.S. efforts such as NEPTUNE, the Nephrotic Syndrome Study Network, and the Kidney Precision Medicine Project. NEPTUNE gives researchers access to observational clinical data, histopathology data, biosamples, whole slide images, and derived datasets. KPMP is building a kidney tissue atlas to identify important cells, disease pathways, and potential therapeutic targets in acute and chronic kidney disease.

Taken together, these efforts point toward a different future for nephrology: one built around deeper phenotyping, tissue-based discovery, better biomarkers, and more precise ways to understand disease progression.

NURTuRE brings a complementary UK perspective. It is charity-led, collaborative, embedded in the kidney research community, and designed to connect patient participation, NHS-linked clinical insight, biosamples, and multi-layered data for broad scientific use. That combination feels especially important now.

AI, digital pathology, genomics, biomarkers, and multi-omic discovery are advancing quickly. But these tools are only as useful as the data and biological context behind them. Precision nephrology will not be built on isolated datasets or disconnected samples. It will require shared platforms that allow researchers, clinicians, industry partners, and patients to work from the same foundation.

Success will not be measured only by how many samples are stored or how many datasets exist. It will be measured by whether NURTuRE helps researchers identify earlier signals of risk, understand why scarring develops, improve prediction of progression, support better trial design, enable new partnerships, and move the field closer to more precise prevention and treatment.

The next era of kidney breakthroughs will depend not only on better science, but on better systems for connecting the science we already have.

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1

Taal MW, Lucas B, Roderick P, et al. Associations with age and glomerular filtration rate in a referred population with chronic kidney disease: methods and baseline data from a UK multicentre cohort study (NURTuRE-CKD). Nephrol Dial Transplant. 2023 Oct 31;38(11):2617-2626. doi: 10.1093/ndt/gfad110. PMID: 37230953; PMCID: PMC10615633.

That was the starting point for our recent Signals webinar with Dallas Renal Group, Michigan Kidney Consultants, and Confido Health.

The conversation went inside one of Texas’ largest nephrology networks to understand what an AI patient access rollout actually looked like, from the earliest pilots to nearly two years of operational use. It also brought in a grounded clinical perspective from Michigan Kidney, where they are actively thinking through how to solve front-office challenges and where AI may fit inside a multi-site nephrology practice.

Participants

• Srinivas Danda, Chief Operating Officer, Dallas Renal Group, where he leads outpatient operations across one of Texas’ largest nephrology networks.

• Kinjel Shastri, nephrologist at Michigan Kidney Consultants, Michigan’s largest board-certified nephrology group, with 45 providers across 16 locations.

• Vichar Shroff, Co-Founder and Chief Product Officer, Confido Health, which builds AI agents for specialty care operations.
  

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What’s inside

• The state of patient access before AI

• Why Dallas Renal Group started with outbound calls

• How the rollout expanded across multiple locations

• What AI handles today, and what still goes to staff

• What was harder than expected

• How Dallas Renal Group measured success

• Where other nephrology practices should start

• What happens when AI encounters an edge case

• What practice leaders should know when evaluating tools

Q&A

What did patient access look like before AI?

Srinivas: Mondays were always the hardest. Patients would wait the whole weekend to call us. They might be calling about prescriptions, checking an appointment date, confirming a location, or trying to follow up on something that had been sitting for a few days. So Monday call volume would spike, and then the volume would slowly come down as the week went on.

The challenge was that we only had so many staff members available to answer calls. Patients would get queued, wait on hold, hang up, and then call back again. That often made the problem worse because they would re-enter the queue and wait even longer. Before AI, our average wait time was more than a minute and a half. A lot of patients would not wait that long. They would drop the call, call back, or bring it up later with the physician during the visit.

That created pain points for patients, doctors, and staff. Staff were under constant stress because the phones were unpredictable. Sometimes they would get a lot of calls at once, and sometimes they would get none. They were trying to do other tasks while also managing the phones.

It also created imbalance inside the office. Some staff felt like they were answering all the calls while others were not carrying the same load. That resentment matters. We even lost a few staff members over time because of that phone burden.

Kinjel: That definitely resonates. I looked at one of our busiest offices, where 10 physicians and four APPs see patients. From January to May, that office had about 3,200 patients. The average call volume for that one office was about 180 calls per day.

For us, that’s being handled by eight people: five MAs and three front-desk staff. And that is before you account for the time it takes a patient to get through the phone tree and reach the right person. On Mondays, my clinic staff spend a huge portion of the day answering messages from the weekend. When we looked at it, MAs were spending about 50% of their time on the phone. If you asked them, they would probably say it feels like 120%.

And that is just returning messages. It does not include the new calls still coming in while those messages are building up.

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What did the AI agent actually sound like to patients?

Vichar: A lot of patient access still happens by phone. That is how many patients schedule, reschedule, ask questions, check locations, or get back in touch with the practice. In the Dallas Renal Group rollout, the AI agent became the first point of contact for many calls. It could answer the phone, identify the patient, confirm whether the patient had seen the physician before, check availability, and schedule the appointment.

One example we played during the webinar was a patient calling back after receiving outbound reminders. The patient wanted to schedule a regular checkup with her nephrologist. The AI agent confirmed her information, looked up her record, asked about her preferred days and times, and offered available appointments.

The important thing is that the AI was not just answering the phone. It was connected to the workflow. It could help with scheduling, follow-ups, prescription refill requests, and location questions. When it could not complete the task, it transferred the call to the right staff member.

Where did Dallas Renal Group start?

Srinivas: We started with outbound calls because we knew exactly why we were calling. That made it a lower-risk starting point. We began with reminders for appointments, lab work, and similar workflows. We also picked an office that already had call-volume problems, so the staff would feel relief if the AI could take some of that work off their plate.

We started seeing results right away. The AI was able to reach more patients than staff could manually because it was consistent. Staff may or may not have time to make every reminder call. With AI, we knew those calls were getting done.

That helped reduce no-shows and cancellations. We were reminding patients about labs two weeks in advance. If we did not reach them, the AI could leave a message. Later, when patients called back, the AI could answer and understand why they were calling.

Once outbound reminders were working, we rolled it from one office to another. After that, we moved into inbound calls. The most important thing before moving to inbound was having a fail-safe backup. If anything went wrong, we wanted to be able to return to our old system within seconds. That was the number one thing we worked on with Confido and our IT team before expanding.2

Where do you start with something like this?

Vichar: We usually follow a methodical deployment process. The first step is getting access to the EHR and phone system so we can run a baseline audit. Before automating anything, you need the practice’s real numbers: call volume by location, answered calls, abandoned calls, hold times, top call reasons, no-show rates, and outbound work that is supposed to happen but is not happening consistently.

Most practices already have much of this data. We bring it together into a scorecard. That scorecard becomes the baseline we hold ourselves accountable to as the AI improves. Then we move into workflow design. In nephrology, the AI has to understand specialty-specific workflows: CKD follow-ups, lab reminders, scheduling rules, what to do, what not to do, and when to transfer.

We always recommend starting low-touch. That means picking a workflow that is meaningful for the practice but low-risk operationally. As people get comfortable and the evidence builds, you can move into higher-touch workflows.

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How did the rollout expand to new locations?

Srinivas: We started inbound in one location where wait times were long but call volume was not too high. We also considered whether the patient population was relatively comfortable with technology.

At first, the AI answered calls and handled simple requests. Many calls were about appointment reminders, confirming appointment details, or asking where the office was. That last one became more important than people might expect.

We have full-staffed offices and timeshare clinics. Patients sometimes get confused about where they are supposed to go. In the past, some patients would check online at the last minute and drive to the wrong location where their doctor also happened to see patients. After implementing AI, we stopped getting as many complaints about patients going to the wrong location. The AI could identify the patient, understand who their doctor was, and route them to the correct office or provide the right location information.

That also improved call routing. In the past, our phone system tried to route calls based on caller ID and other rules, but it did not always work. A call for one physician might go to a location where the staff did not know that doctor’s schedule. Then they had to spend more time helping the patient or transferring the call. With AI, the system can figure out who the patient is, who their doctor is, and where the call should go.

Once the AI was screening calls and handling simpler requests, we moved to scheduling. Then we added prescription refill requests, where the AI could create telephone encounters in the EMR for staff to review. It was a step-by-step approach.

Why not have every patient go through AI?

Srinivas: Some patients still call and immediately say, “I want to talk to a staff member.” We made a policy decision that if a patient says that, we transfer the call. We do not want the AI to keep questioning them or create frustration. The goal is to help patients, not annoy them.

Over time, we think more patients will trust the system. One way we are helping that happen is by keeping AI available after hours. If patients call after hours to check an appointment, reschedule, or ask for basic information, the AI can help them.

Some patients who are hesitant during business hours may try it after hours because no staff member is available. Once they have a good experience, they may be more comfortable using it the next time.

What was harder than expected?

Srinivas: The hard part was not getting AI to work on simple workflows. The hard part was integration. For us, the biggest challenges were connecting with the EMR and the phone system. We use eClinicalWorks as our EMR and 3CX as our phone system, and we ran into issues with the phone system, the SIP trunk provider, concurrent call volume, and EMR limitations. Those technical pieces took more time than anything else.

The other important part was staff communication. We made sure managers clearly told staff this was not being implemented to create layoffs. It was being implemented to help them and take work off their plate.

That reassurance mattered. Without it, the rollout could have created anxiety before staff ever had a chance to see the benefit.

Vichar: I agree, the first major roadblock we see is usually EMR integration. A lot of these systems are older and not very API-friendly. You have to do a lot of work to make sure the AI can integrate in real time. You also need fallbacks because systems have downtime, rate limits, and restrictions on how many requests you can make. Some EMRs are more modern and supportive. Others are built on older systems or on-premise infrastructure. Either way, you have to make sure the AI can still function reliably.

The second challenge is change management. In the first 90 days, a lot of time is spent with operational owners, administrators, and leadership. They need to sign off on escalation logic, red flags, tone, workflow rules, and how the AI should behave with their patient population.

Multi-site groups add another layer of complexity. Every site may have its own scheduling rules, managers, habits, and preferences. A corporate mandate lands very differently than a peer saying, “This gave me my afternoon back. You should try it.”

That is why we like starting with one site, building proof, and then using that proof to expand to other sites.

How did Dallas Renal Group measure success?

Srinivas: Productivity matters, but it was not the first thing I cared about. For me, the bigger question was whether we were reducing staff burnout and improving patient access. If staff have fewer interruptions, they can do their jobs better. That means patients get helped faster, physicians hear fewer complaints during visits, and the office feels less chaotic.

The first visible sign was simple: the phones were ringing less. Managers started telling me staff were not complaining about the phones as much. Doctors stopped hearing as many patient complaints about hold times. Staff could focus more on rooming patients, documentation, messages, and other work instead of constantly stopping to answer calls.

The productivity gain is real too. We are doing more work with the same number of staff, and Confido is handling roughly the work of three full-time team members at a lower cost than hiring three additional people.

But the bigger value is knowing that patients are getting reminders, calls are being answered, and we have better data on why patients are calling. That data is now helping us design new workflows and think more proactively about how to reduce avoidable calls over time.

Kinjel: That resonates because MA (Medical Assistant) retention is a real issue in nephrology practices. A lot of staff feel like they are carrying more of the phone burden than others. They answer five messages, look up, and see ten more waiting. That wears people down.

Lab reminders are a good example. Some staff tell me they have to call patients four or five times to remind them to get labs done. That is a standardized task, and it is exactly the kind of work AI should be able to help with.

When I talk to physicians in other specialties, they are dealing with the same staffing problem. Practices lose MAs to other businesses and other companies. A large part of that burden is phone calls, messages, chart prep, and other repetitive work. So using staff morale as a measure of success is important.

So I do think staff morale belongs in the success metrics. If you can reduce repetitive phone work, give MAs more room to focus, and make the day feel less reactive, that matters.

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Where should another nephrology practice start?

Srinivas: Start with the pain point. What problem are you actually trying to solve? Is it missed calls? No-shows? Lab reminders? Routing? Staff interruptions? Look at your current technology, your current workflows, and where the biggest operational pressure is coming from. Once you know that, start small and prove it.

Kinjel: I would start with standardized outbound calls, especially appointment reminders and lab reminders. Those are repetitive, high-burden workflows that do not require the practice to change everything at once. Pick one office, make sure it works for your staff and patient population, and then expand.

Vichar: The baseline audit helps make that decision. For many practices, outbound reminders are the lowest-risk starting point. For inbound calls, existing-patient scheduling and prescription refills are usually better early workflows than new-patient intake because they are more standardized. Start with existing patients, prove the workflow, and then expand.

Why choose voice instead of text?

Srinivas: We tried text-based systems in the past. The challenge is two-way communication. If a patient sends a message and you do not respond quickly, the patient may be unhappy. And we cannot always have the right person respond immediately. With voice, the system can talk to the patient, understand what they need, respond, and transfer the call if necessary.

Patient demographics matter too. Nephrology patients are often older. Many prefer phone calls over text messages. Some patients are in nursing homes or group homes, where a call may go directly to staff who help coordinate care. We still use text messages in some cases. If we cannot reach a patient and we have a mobile number, we may send a text. But voice made more sense as the primary channel for our population.

Kinjel: We recently started using text reminders for appointments, but it is still early. Some patients opt in, some do not. With our population, it is probably close to 50/50. Texts can also be easy to miss. Patients may have 20 messages sitting there. With a phone call, especially through an AI agent, you can track that the patient was called at a specific time and that a reminder was delivered. And for nursing home patients, group home patients, or patients who rely on staff for coordination, the phone often works better.

What happens when AI encounters an edge case?

Vichar: Edge cases are the whole game. Anyone can demo the happy path. What matters is how the agent behaves when something falls outside its lane and how often that happens.

The default behavior has to be fail-safe. If the AI cannot handle something or should not handle it, like a clinical question, it should not improvise. It should escalate. That may mean transferring the call. If it cannot transfer the call, it can create a telephone encounter in the patient chart with a structured summary so staff can take action later.

The AI should do what a good human staff member would do: recognize the limit, preserve the context, and route it appropriately. Because workflows are tightly scoped before go-live, true edge cases are relatively uncommon. But when they do happen, we use them to improve the system so that some edge cases stop being edge cases in the future.

Srinivas: We trained the system using a lot of our own historical phone calls. That helped because it could learn what kinds of calls patients actually make, how staff handle them, and where the system should escalate.

The step-by-step approach also helped. We did not try to automate everything at once. We trained the system, watched what happened, and added more knowledge over time.

What does a baseline audit include?

Vichar: We call it a current-state assessment. On the phone-system side, we look at call volume by office, call volume by patient, missed-call ratios, abandonment rates, where patients are dropping in the phone tree, and where the biggest gaps are.

If the practice records phone calls, we can also analyze transcripts and sentiment. That helps identify what calls are actually about. For example, 40% might be scheduling, 30% might be prescription refills, and the rest might be clinical questions, insurance calls, provider referrals, or other issues. Then we present that data back to the staff and leadership team. The goal is to decide which workflows to start with based on volume, structure, and operational readiness.

On the EMR side, we look at provider schedules, templates, blocks, scheduling rules, no-show rates, empty slots, and care gaps. That helps us identify where outbound campaigns may help. For example, if CKD stage 4 or 5 patients need to be seen every few months and are not coming back in, the AI can help get those patients scheduled.

Can this connect to chronic care management, RPM, or value-based care programs?

Vichar: Yes, but it depends on the workflow:

• For RPM, we are not integrating directly with devices. We are acting more like phone support, the way a staff member would.

• For chronic care management and value-based care programs, AI can help with outbound campaigns by phone, text, or email. It can help engage patients, support enrollment, and bring patients back into the practice.

A lot of practices use AI for value-based care programs by identifying patients who need follow-up, scheduling visits, reminding patients about labs, or helping close care gaps. The point is that AI can act like an additional staff member that can make a high volume of calls at once and help bring patients back into care.

What should leadership consider before approving a rollout?

Srinivas: We were an early client for Confido. The first project I gave them was analyzing phone call recordings. That gave us insight into what was happening on calls and where the problems were. Then I went to management and explained that this was a new technology we wanted to test because everyone already knew phone calls were a major issue. We started with a smaller budget and limited scope. Within six months, we saw strong results. After that, we increased the budget and launched across the practice.

For leaders, I think it helps to start with a known pain point, test it in a controlled way, and then expand once the results are clear.

What advice would you give practices considering AI now?

Srinivas: When you implement something like this, AI can become the scapegoat. If anything goes wrong, people may immediately blame the AI. That happened to us several times. I would call Vichar and say, “Something is going on. We need to look at this.” His team would investigate and often come back with the actual root cause.

That support was important because it helped us address false alarms quickly. You need to take feedback seriously. Look at every issue. Find the root cause. Fix what needs to be fixed. Over time, confidence builds.

Scheduling is still very complex in nephrology, especially with multiple locations and timeshare clinics. We still find things to improve, like overbooking issues or appointment-creation rules. But those are solvable. Like any technology, give it time to mature. Work with the vendor, patients, and staff. Take feedback seriously and keep improving the system.

Kinjel: I would point out every practice structure is different. What you look for at 90 days may be different from what you look for at 18 months. Workflows vary by office. Patient populations vary. Technology comfort varies.

The ability to customize the system to what your practice actually needs is important. It may not look the same in every office.

That is one of the biggest things I took away: start with your own workflow, your own patient population, and your own operational needs.

Vichar: This is an exciting time because everyone is talking about AI. But practices need to judge what they actually need automated. AI should not be framed as taking jobs away. It should help the current team become more productive.

The first reaction from staff may be fear because AI is still unfamiliar. But the goal is to help staff do their jobs better and improve patient access. There are many tasks humans cannot consistently do today because there are only so many working hours in a day. AI can be available 24/7 for the right workflows.

That can help the practice, the staff, and the patient.3

If you’re working through similar questions in your practice, we’d love to hear what you’re learning. Leave a comment below or share this with a colleague.

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Your curated list of high priority open roles across the kidneyverse, delivered straight to your inbox every two weeks. This edition features senior roles across medical affairs, product, research, venture investing, and business development as kidney disease and CKM pipelines continue to grow.

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At A Glance

• Head of Nephrology, US Medical Affairs (Biogen)

• Senior Manager, Digital Product (CVS Health)

• Manager, Tech Investing (Lilly Ventures)

• Senior Manager, Strategic Innovation & BD (McKesson)

• Director, Global Patient Solutions Strategy & Value (AstraZeneca)

• Medical Science Liaison, Nephrology (Veloxis)

• Director of Cardiovascular Research (Intermountain Health)

• Business Development Lead, Life Sciences & Medtech (Verily)

• Division Vice President (DaVita)

• Associate Director, Renal Rare Disease TLL (Otsuka)

• Director, Social Impact (Novartis Foundation)
  
  

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Open Roles

1. Biogen is hiring a Head of Nephrology, US Medical Affairs (Cambridge, MA, Hybrid) to lead the strategic direction and execution of nephrology medical affairs, overseeing Medical Directors, Field Directors, and MSLs across a high-growth therapeutic area. The ideal candidate brings an MD, PhD, or PharmD, 12–15+ years of medical affairs experience, and 3+ years in nephrology. Biogen is a global biotech with a growing portfolio targeting IgA nephropathy and rare kidney diseases. Apply here.

2. Novo Nordisk is hiring a Medical Director, Diabetes & Renal TA (Plainsboro, NJ, Onsite) to serve as the subject matter expert driving scientific exchange with KOLs and HCPs, supporting evidence generation, medical education, and promotional review across the diabetes and renal portfolio. The ideal candidate brings an MD, DO, PhD, or PharmD, 5+ years of combined clinical or pharma experience, and strong clinical familiarity with diabetes and renal disease. Novo Nordisk is a global leader in diabetes and cardiometabolic care with a growing renal portfolio spanning CKD, cardiovascular risk reduction, and metabolic disease. Apply here.

3. CVS Health is hiring a Senior Manager, Digital Product — Client & Clinical Experience (Remote) to lead product development across clinical and client-facing digital products, owning roadmap, backlog, and cross-team delivery. The ideal candidate brings 7+ years of product experience and comfort working across engineering, design, and senior stakeholders. Apply here.

4. Lilly Ventures is hiring a Manager, Tech Investing (Indianapolis, IN, Onsite) to support direct equity investments, fund-of-funds activity, and value pull-through across AI/ML, computational biology, and platform technologies driving drug discovery and development. The ideal candidate brings 3+ years of experience in data analytics, consulting, or investing in life sciences, with strong organizational and problem-solving skills. Lilly Ventures is the corporate venture arm of Eli Lilly, operating at the intersection of venture capital, biotech innovation, and R&D transformation. Apply here.

5. McKesson is hiring a Senior Manager, Strategic Innovation & Business Development (Irving, TX, Onsite) to design, test, and launch enterprise-wide pilots leveraging AI and advanced analytics to drive measurable business value and modernize workflows. The ideal candidate brings 4+ years of management consulting or internal strategy experience, a digital-first mindset, and a track record of translating ambiguous problems into scalable solutions. McKesson is one of the largest healthcare distribution and technology companies in the world. Apply here.

6. AstraZeneca is hiring a Director, Global Patient Solutions Strategy & Value (Gaithersburg, MD, Hybrid) to translate patient insight, behavioral science, and AI into personalized support experiences across oncology and biopharma indications at global scale. The ideal candidate brings 5+ years of biopharma experience and a background in patient engagement and behavioral science. AstraZeneca has a significant and growing presence in cardiovascular, renal, and metabolic disease. Apply here.

7. Veloxis Pharmaceuticals is hiring a Medical Science Liaison, Nephrology (Remote) to build relationships with transplant healthcare providers and key opinion leaders, supporting scientific exchange, medical education, and outcomes research. The ideal candidate brings a doctoral degree, 3–5 years of clinical experience, and established transplant or nephrology relationships. Veloxis is an Asahi Kasei company focused exclusively on transforming transplant medicine. Apply here.

8. Intermountain Health is hiring a Director of Cardiovascular Research (Salt Lake City, UT, Onsite) to lead a well-funded research enterprise, shaping strategy across outcomes research, clinical trials, and prevention innovation. The ideal candidate is a board-certified cardiologist with MD or DO, clinical trial leadership experience, and prior medical director experience. Intermountain Health is a leading not-for-profit health system with a strong and growing focus on cardiometabolic disease. Apply here.

9. Verily is hiring a Business Development Lead, Life Sciences & Medtech (Remote, New Jersey) to drive commercial growth by sourcing and closing strategic partnerships with life sciences and medtech customers. The ideal candidate brings an MBA or advanced degree, 10+ years of BD or strategic partnerships experience in healthcare technology, and a proven deal sheet with deep relationships across the life sciences and medtech space. Verily is a data platform and technology company purpose-built to power AI-enabled precision health solutions. Apply here.

10. DaVita is hiring a Division Vice President (Gilbert, AZ, Onsite) to lead operations across ~70 dialysis centers spanning Arizona, New Mexico, and Colorado, overseeing $350M+ in annual revenue and 700+ teammates. The ideal candidate brings 10+ years of progressive management experience, an MBA strongly preferred, and a background in management consulting with a strong ownership mindset. DaVita is one of the largest kidney care providers in the US. Apply here.

11. Otsuka is hiring an Associate Director, Renal Rare Disease Thought Leader Liaison (Remote) to build and strengthen relationships with key opinion leaders across academic centers and leading nephrology practices. The ideal candidate brings pharma or biotech experience, an advanced clinical or scientific degree, and deep knowledge of rare renal disease. Otsuka is a global pharmaceutical company with a growing rare kidney disease portfolio including treatments for IgA nephropathy. Apply here.

12. Novartis is hiring a Director, Social Impact (onsite) to lead execution of the Novartis Foundation's Americas social impact portfolio, overseeing multi-year strategic partnerships focused on health equity and community outcomes across North, Central, and South America. The ideal candidate brings extensive experience in corporate philanthropy or social impact, a strong strategic mindset, and proven ability to manage complex multi-stakeholder programs. Novartis is a global pharmaceutical company with a significant and growing presence in kidney and cardiometabolic disease. Apply here.
    

Every one of these roles is a chance to move the needle on kidney health. We hope you find yours. More roles added weekly at jobs.signalsfs.com.

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Are you hiring? Post a role on Signals Jobs. Looking for your next opportunity? Browse the full board. We believe great talent is everywhere, and that the right people in the right roles get us closer to a world without kidney disease.

A home dialysis bill is moving through Congress with a small but important payment signal. Rep. Carol Miller introduced the Improving Home Dialysis Act, which would add two new Medicare-covered support services for patients dialyzing at home beginning January 1, 2028: staff-assisted home dialysis respite care and renal mental health services. The bill applies to support furnished in the patient’s home, excluding skilled nursing facilities and nursing facilities.1

The biggest detail is the budget neutrality waiver. A Ways and Means letter says payment adjustments for both staff-assisted respite care and renal mental health services “shall not be made in a budget neutral manner.”2 Simply put, that means Medicare would not have to fund the new payments by cutting other ESRD payments. If it were budget neutral, the new add-on could simply reshuffle dollars inside the dialysis payment system. With the waiver, it looks more like incremental reimbursement for support that often sits in the gap between what patients need and what the current payment model clearly pays for.

Background

Home dialysis has long been one of kidney care’s most obvious but under-supported opportunities. Patients often prefer the flexibility and independence of home-based care, but the transition is hard. Training takes time, care partners carry real burden, and early complications can quickly derail confidence. Mental health needs can be significant during this period, yet easy to miss. And for many patients, a temporary illness, injury, or physical limitation can make home treatment feel impossible. That is the practical gap this bill is trying to address: when home becomes too hard for a period of time, the current system does not always give patients or care partners a clear way to get help without risking a return to in-center dialysis.

Two recent reviews help explain why that transition window matters. Home hemodialysis studies report one-year technique failure rates ranging from 2% to 30%, with the highest attrition often occurring early and driven by medical instability, confidence gaps, and patient or caregiver burnout.3 Peritoneal dialysis studies show a similarly wide range, with discontinuation often reported between 6% and 40% depending on the definition and time period, and early failures tied to mechanical issues, peritonitis, psychosocial factors, and late referral.4

I have written about these barriers before. The IM-HOME study helped frame the home dialysis journey as a sequence of barriers across referral, education, training, initiation, and maintenance, with patients, care partners, providers, equipment, home environment, and clinic workflows all shaping whether home dialysis actually works in practice.

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Figure: Conceptual model of the patient journey to home dialysis5

This bill targets that messy middle. Staff-assisted respite care would cover dialysis services furnished by qualified personnel when a home dialysis patient is temporarily unable to dialyze independently. The support would be available during the first 30 days after initiating home dialysis, or at any time if the patient’s limitation is physical. Qualified personnel could include registered nurses, licensed practical nurses, certified patient care technicians, or other qualified medical professionals defined by the Secretary. The bill would also cover up to four renal mental health sessions during the first 60 days after home dialysis initiation.

The National Kidney Foundation called the bill an “important first step” and said it recognizes “the real-world challenges patients and caregivers face while adapting to home-based care.”6

Why it matters

This is not a sweeping home dialysis overhaul. It is narrower, and probably more practical. The bill recognizes that access is not just modality education, equipment, or patient preference. Access also means having enough support to get started, recover from setbacks, and stay home when life gets complicated.

For providers, the proposed payment structure could make it easier to justify staffing models around home starts and rescue support. For patients, it could make home dialysis feel less like an all-or-nothing leap. For the market, it is another sign that policymakers are still looking for ways to move kidney care closer to the home.

Table 1. Illustrative payment impact per home dialysis patient

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This will not fully solve the economics of assisted home dialysis. Using the 2025 ESRD PPS base rate as a rough benchmark, the maximum support would equal about 3.6% of annual base-rate payments for a non-rural patient and 4.9% for a rural patient. But that may understate the point. These dollars are concentrated around the most fragile part of the home dialysis journey: initiation, early confidence, temporary setbacks, and caregiver strain. Measured against the first two months of base-rate payments, the maximum support could represent roughly 22% to 30% of that early transition window.

At the same time, the payment levels themselves seem low. The non-rural mental health payment in the bill would be roughly $24 per session using the current formula. How should providers realistically deliver meaningful mental health support at that rate?

That is why this matters. The bill does not rewrite the full home dialysis P&L, but it could make the first few weeks at home less fragile and give providers a clearer reason to invest in transitional staffing, rescue support, and mental health resources around home starts.

Timing and market fit

This also lands at a moment when home dialysis is already moving in the right direction thanks to targeted interventions and new payment models. Home dialysis use reached about 15% of new and established ESRD patients in 2023, its highest level in over a decade.

A version of this bill may increase access, but the more interesting test is how much it could change the rate of growth and how existing kidney care models would adapt. As Lekha Tummalapalli and Eugene Lin pointed out in 2022, value-based payment models and capitated Medicare Advantage arrangements would increase interest in home dialysis as a total-cost strategy, while also raising a harder concern: whether some savings depend on costs shifted to patients and care partners through unpaid labor, utilities, and home support.7

Since then, KCC results have shown that value-based kidney models can increase home dialysis, home dialysis training, and optimal ESRD starts, even as the savings picture remains more complicated. That makes H.R. 8875 worth watching as a potential payment layer around the early transition window where home dialysis succeeds or fails. For risk-bearing models, the bigger opportunity may be reducing hospitalizations and adverse events through more frequent home touchpoints. That includes dialysis-related complications like infection, but also broader risks tied to fluid status, blood pressure, medication adherence, and cardiac instability. The bill itself is written around dialysis respite care and renal mental health services, so CMS implementation would determine how much broader monitoring or coordination could be built into the workflow.

The organizations watching this are broader than the usual public-company list. They include large dialysis organizations built around outpatient clinic networks, dedicated home-only providers already building staff-assisted and transitional home models in markets like Chicago, Michigan, Florida, and others, and home care companies that specialize in complex care, social support, and clinical coordination in the home. For each of them, the question is whether this creates a more durable payment layer around the work required to help patients start, stabilize, and remain at home.

That is also why DaVita’s recent investment in Elara felt important. As we wrote in February, the move was less about home dialysis alone and more about building the operating layer for kidney care in the home: staffing, coordination, continuity, and support around complex patients.

The unresolved issue is what kinds of support models policymakers ultimately want to enable. Is the goal narrowly defined respite care, or a broader home support infrastructure that includes in-home training, interdisciplinary support, caregiver relief, monitoring, and flexible workforce models that can realistically scale?

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What happens now?

The bill still needs broader support to move, including Democratic support. That is the next real hurdle, especially now. Home dialysis has often been one of the few areas in kidney policy where patient choice, cost management, and care delivery innovation can appeal across party lines.

It also fits into a longer policy arc. The 2019 Advancing American Kidney Health Initiative set a national goal to increase home dialysis and transplantation, and NKF noted that this bill builds on that foundation.8 In that sense, H.R. 8875 is less a new direction than a continuation of an existing federal push to expand treatment options for people with kidney failure.

The policy details will matter. CMS would need to define operational rules, personnel requirements, training standards, billing mechanics, and how these services fit into the ESRD payment system. Those details will determine whether this becomes a meaningful support layer for home dialysis programs or a narrow add-on that is difficult to operationalize and potentially limiting for the providers and patients it is meant to support.

For now, the signal is worth watching. The field has spent years talking about increasing home dialysis, but the support model has lagged the ambition. This bill starts to put payment behind practical services that could make home dialysis more sustainable: help during the first few weeks, support when a patient hits a setback, and mental health resources during a high-friction transition.

What the field is watching

The early response from the field has been encouraging, though many people see this as a starting point rather than a real solution. What types of support actually help patients remain at home? Which workforce models are realistic? What services need to happen in the clinic versus the home? And how should payment be structured so programs can sustainably provide those services without narrowing access?

A new CJASN perspective from Drs. Yuvaram Reddy, Suzanne Watnick, and Nupur Gupta makes a similar point. The authors argue that assisted home dialysis could help more patients, including frail or socially disadvantaged patients, access home dialysis, while noting that current Medicare policy lacks a clear reimbursement pathway for in-home dialysis assistance. They also caution that a nurse-only model would be difficult to scale, which makes the bill’s “qualified personnel” language important. The current text includes registered nurses, licensed practical nurses, certified patient care technicians, and other qualified medical professionals specified by the Secretary.

That may be the most important takeaway from this version of the bill. The field still needs clearer input from the people closest to this work: patients, care partners, social workers, home dialysis educators, nurses, technicians, and providers actively delivering care in the home. If policymakers want these models to succeed in the real world, they need to understand what support is actually feasible, useful, and sustainable at the bedside and in the home.

I’d love to hear what you think: can targeted payment support make home dialysis more accessible, and what would need to change for this type of policy to be truly workable in the real world?

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Author’s note: My thanks to everyone who shared thoughts and experiences that helped shape this piece, especially patients and care partners who know these hurdles firsthand and the many clinicians, operators, and advocates working to help more people realize the benefits of doing dialysis at home.

This month's issue reflects our belief that this field has a new sense of urgency. FDA approvals, major M&A, new platforms, payment model debates, and a research pipeline that keeps expanding. We've spent decades focused on a reactive endpoint, and it's time we build for a new generation. As always, thanks for being here and for sharing this with your networks.1

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What’s Inside

• News: FSGS approval, Biogen/Apellis, AI health access, Carna/Renalytix, NKF investment, multiple seed rounds

• Research: Cardiac risk equations, APOL1, transplant outcomes, precision platforms, organ transport, ACCESS model, Medicare rules, ACO analytics

• Community: FDA workshops, living donation, APOL1 roundtable, KDIGO updates on IgAN, green dialysis, ISN primary care sheets

• Events: Kidney innovation, Vascular access, ERA, LSI Asia, Korea’s KSN, Transplant congress, BIO international, Mayo’s nephrogenetics update

• Jobs: Travere, Monogram, Ardelyx, Akebia, Vertex, AstraZeneca, Interwell, Vantive, Amgen + dozens more on jobs.signalsfs.com
  
  

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This issue is made possible by Nsight Health. In CKD patients with Stage 2 hypertension, Nsight's clinically managed RPM and CCM programs have been associated with a 17 mmHg reduction in systolic blood pressure, one of the most meaningful levers for slowing kidney disease progression. Nsight monitors 130,000+ patients across 1,700+ providers nationwide with a dedicated U.S.-based care team available 24/7. Download their 2026 Clinical Evidence White Paper for outcomes data across hypertension, CKD, heart failure, and diabetes.

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News

• Biogen completed its $5.3B acquisition of Apellis Pharmaceuticals last week, adding EMPAVELI and SYFOVRE ($689M in 2025 revenue) and making a serious push into nephrology. Apellis's commercial infrastructure also positions the launch of felzartamab, with a Phase 3 readout in transplant patients expected in H1 2027.

• Travere’s Filspari just became the first FDA-approved treatment for FSGS, a rare kidney disease that scars the kidney's filtering units and often leads to kidney failure. The drug blocks two separate pathways that drive kidney damage, and a clinical trial of 375 patients showed it reduced protein in the urine by 46% compared to 30% for the current standard of care. A long-awaited milestone for the estimated 30,000+ Americans living with this disease.

• Renalytix and Carna Health announced a partnership pairing the FDA-approved kidneyintelX.dkd diagnostic with Carna's AI-driven care management platform to connect population-level CKD screening to precision intervention Real-world data from the collaboration showed patients flagged as high risk by the test were 4.5x more likely to be prescribed kidney-protective medications including SGLT2 inhibitors.

• Redesign Health invested $2.75M to lead a seed round in Gravity Rail, an AI platform that lets care teams build and manage their own patient engagement workflows using natural language rather than code, putting clinical operations teams in control of their own protocols without relying on engineers or outside vendors. Early production results from a CKD program at a large academic medical center showed engagement increasing beyond 12 weeks and a 5x efficiency gain for care managers, with a roadmap to expand across a 25,000-patient population. (H/t Neil Patel)

• The National Kidney Foundation's Innovation Fund has invested in Biohope, a biotech developing precision diagnostics to personalize immuno-suppressive therapy for kidney transplant recipients. Biohope's flagship platform, the Immunobiogram, is an in vitro diagnostic designed to help clinicians tailor immunosuppression to individual patients rather than relying on the trial-and-error adjustments that currently drive many cases of rejection, infection, and graft loss. The investment will support clinical validation studies and a path toward U.S. regulatory approval.

• Evergreen Nephrology announced a partnership with Phamily, Jaan Health's AI-powered disease management platform, to extend care coordination beyond the clinic for kidney patients across the full care journey. The integration aims to give nephrology practices the operational infrastructure to bridge into value-based care while supporting better patient outcomes and sustainable revenue. The partnership reflects a broader trend of specialty-focused platforms building the connective tissue between clinical care and VBC economics in nephrology.

• Nearly 1 in 4 Americans now turn to AI tools for health information, most often for speed, convenience, and access outside normal business hours, according to a new AP report drawing on a West Health-Gallup poll of 5,660 U.S. adults. The top reasons cited were wanting quick answers (71%), seeking additional information (71%), and curiosity about what AI would say (67%), while access barriers including cost, time, and feeling dismissed by providers also drove a meaningful share of users. As UC San Diego Health's Chief Health AI Officer Karandeep Singh notes, AI is becoming a more efficient entry point to health information, an evolution of the Google search but with synthesized, conversational answers. “The opportunity here is big, but so is the responsibility to get it right.” (H/t Karandeep Singh)

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Research

• The largest-ever global validation of two leading cardiovascular risk tools, the AHA's PREVENT equations and the ESC's SCORE2, finds both perform comparably well across diverse geographies and clinical settings, according to a new open-access study in Nature Medicine spanning 60+ trials and observational cohorts enrolling nearly 6.5 million individuals. A notable finding for the kidney community: adding albuminuria to either model meaningfully improved risk discrimination, particularly for heart failure, reinforcing the case for routine albuminuria measurement across the cardio-kidney-metabolic spectrum. The findings support broader adoption of both tools for cardiovascular risk stratification globally and strengthen the clinical rationale for integrating kidney biomarkers into standard cardiovascular risk assessment. (H/t Brendon Neuen)

• The ERA's most recent Annual Report, covering 2023, reveals that the cause of kidney failure remains unknown in 20% of cases, with many likely misclassified as renovascular or hypertension-related. The report also highlights striking incidence variation across Europe and within individual countries, pointing to gaps in diagnosis, classification, and surveillance that persist across healthcare systems. A useful benchmark for anyone tracking the global epidemiology of kidney failure. (H/t Andreas Kronbichler)

• Novartis, Novo Nordisk, and University of Pennsylvania colleagues have identified a nine-protein blood signature that may predict which individuals with high-risk APOL1 genotypes are most likely to experience rapid kidney function decline, according to a new study in Nature Medicine. The signature was identified and validated through large-scale protein profiling of more than 850 individuals and could enable earlier, more targeted intervention for a population that faces disproportionate rates of kidney failure. Beyond clinical application, the findings may also inform trial design and drug development strategy for APOL1-targeted therapeutics. (H/t Fiona Marshall)

• MEDA-PKD is a new real-time analytics platform designed to advance precision care in ADPKD, integrating clinical, imaging, laboratory, patient-reported, and omics data from 1,735 patients into a continuously updating interactive dashboard. A standout finding from the platform: real-world longitudinal data showed tolvaptan reduced kidney function decline by roughly 27%, closely mirroring pivotal trial results and validating the approach for monitoring therapeutic impact in practice. The preprint positions MEDA as a model for continuously learning health systems and scalable precision medicine infrastructure well beyond ADPKD. (H/t Roman-Ulrich Müller)

• Population modeling across 1.2 million genomes suggests a substantially underdiagnosed cohort of NPHS2-related FSGS in the United States, largely driven by an adult-onset variant combination that may be going unrecognized in clinical practice, according to a new study combining genomic databases with real-world genetic testing data from Natera's Renasight panel. Roughly 77% of predicted US cases involve R229Q compound heterozygosity, an adult-onset genotype partly explained by the A284V variant prevalent in individuals with admixed American ancestry, a population not well captured by existing FSGS screening frameworks. The findings strengthen the case for routine genetic screening in adult FSGS, both to guide immunosuppression decisions and to stratify patients for emerging targeted therapies. (H/t Wen Yi Ding)

• Geisinger researchers have released DxFit, an open-source tool that matches genetic disorder findings to EHR diagnoses, addressing a persistent bottleneck in population genomics research where confirming disease manifestation from billing codes and clinical records is slow and inconsistent. The ensemble approach combines four strategies including gene name searches, ICD-to-Mondo ontology mapping, word embedding similarity, and Jaccard matching, achieving sensitivity of 88.7% and specificity of 86.2% on a cohort of 350 patients with confirmed genetic diagnoses. As genomic-first approaches become more common in kidney and rare disease research, tools like DxFit that can validate phenotypic expression at scale in real-world EHR data will be increasingly valuable for prevalence and penetrance studies. (H/t Rebecca Torene)

ORGAN TRANSPLANT

• Recipient risk, not donor quality, is the dominant driver of long-term lung transplant survival, according to a retrospective UNOS registry analysis of more than 20,000 lung transplants from 2018 to 2025. Low-risk recipients tolerated extended-criteria donor lungs without any meaningful survival penalty, while high-risk recipients had worse outcomes regardless of donor quality. The findings have direct implications for organ allocation strategy across solid organ transplantation, supporting broader use of extended-criteria donors when matched to appropriate recipients. (H/t Rajat Walia)

• Tracking donor-derived cell-free DNA (dd-cfDNA) trends in the eight weeks following kidney transplant rejection may help clinicians predict which patients will recover and which will not. That’s according to a prospective multicenter study published in AJT that included 66 biopsy-proven rejection cases. Researchers identified four distinct dd-cfDNA trajectory patterns, two favorable and two unfavorable, with favorable trends associated with 60 times higher odds of positive outcomes and 13 times higher odds of resolving kidney dysfunction at one year. The findings position dd-cfDNA as a dynamic, noninvasive tool for post-rejection risk stratification rather than a one-time diagnostic snapshot. (H/t Yasir Qazi)

• A centralized normothermic machine perfusion (NMP) service rescued 90% of donor kidneys that had already been declined through standard allocation, according to a new study in AJT led by 34 Lives CEO Chris Jaynes. Despite longer cold ischemia times, kidneys that underwent NMP experienced significantly lower rates of delayed graft function compared to non-NMP kidneys (26% vs. 60%), with similar overall graft survival. The authors note that additional follow-up is needed to determine long-term graft function outcomes. (H/t 34 Lives)

• A Letter to the Editor in Transplant International makes the case that aerial drone transport of donor organs is transitioning from proof of concept to clinical readiness, with current fully electric models reaching speeds of 100 km/h and ranges over 100 km, and larger hybrid drones capable of 500+ km range with 40 kg payload capacity. Beyond speed, the authors highlight logistical, economic, and safety advantages including reduced cold ischemia time, lower carbon footprint, and elimination of the fatigue and accident risk that comes with overnight road transport by surgical teams. Regulatory frameworks remain the primary barrier, as medical drone operations are currently governed by civilian aviation law, and dedicated aerial networks for organ transport will require targeted policy engagement to become a clinical reality. (H/t Joe Scalea)

• Despite improved early outcomes, long-term kidney transplant graft survival has plateaued and is now declining, according to a new single-center cohort analysis of 50 years of transplant data published in Transplantation Journal. The trend is driven by older, more comorbid recipients and a rise in infection-related deaths in the modern era. The findings underscore the need for precision immunosuppression tailored to an aging, comorbid transplant population.

• Researchers at UHN have built AI-powered digital twins of human lungs trained on 951 organs from the world's largest ex vivo lung perfusion dataset, enabling the physical organ to receive a treatment while its digital counterpart serves as the untreated control in the same experiment. The approach uses paired causal inference to detect drug efficacy with just 6 lungs rather than the roughly 18 required by traditional methods. While developed for lung assessment, the underlying framework points toward a broader shift in preclinical evaluation across solid organ transplantation and beyond. Is anyone working on this approach for kidneys? (H/t Bo Wang)

POLICY & PAYMENT MODELS

• Three FDA workshops held in the past month reflect a kidney research community actively wrestling with two foundational questions: for whom are we developing treatments, and for what outcomes? Efforts spanning Alport Syndrome, congenital kidney diseases (CAKUT), and acute kidney injury following cardiac surgery each revealed the same underlying challenge: clinical definitions built for patient care are too imprecise to anchor drug development. Highlights include the launch of the ASSENT surrogate endpoint network for Alport Syndrome, a CAKUT Road to Trial Readiness Summit co-hosted by the Kidney Future Foundation and FDA, and a KHI-FDA workshop on cardiac surgery-induced AKI that is expected to yield a forthcoming manuscript on alternative primary endpoints. (H/t Mark David Lim)

• Three major Medicare payment rules affecting nephrology are currently under OMB review and on track for their typical late June or early July release, including the Physician Fee Schedule, ESRD Prospective Payment System, and the Hospital Outpatient and Ambulatory Surgical Center Payment System. No surprises in the timing, but the simultaneous movement of all three rules makes this a consequential window for the specialty. Worth watching as proposed rules drop this summer. (H/t Rob Blaser)

• The FDA issued a public call this week for input on drug repurposing, inviting patients, clinicians, researchers, and stakeholders to identify already-approved drugs that may have untapped potential for diseases with significant unmet need, including metabolic diseases, rare diseases, and neurodegenerative conditions. The agency is seeking nominations for priority disease areas, drug candidates with existing supporting evidence, and input on the barriers that currently limit repurposing development. Submit a public comment here.

• CMS Innovation Center leaders Jacob Shiff and Abe Sutton published a JAMA Perspective laying out the rationale behind the ACCESS Model and its Outcome-Aligned Payment approach, which shifts reimbursement away from activity-based billing toward measurable clinical improvement relative to each patient’s baseline. The model covers four chronic condition tracks including a cardio-kidney-metabolic track spanning hypertension, CKD, diabetes, and atherosclerotic cardiovascular disease, and allows care to be delivered in person, virtually, or asynchronously. The core argument is that fee-for-service has long distorted healthcare technology toward billing optimization rather than clinical outcomes, and ACCESS is a structured attempt to realign those incentives. (H/t Christian Pean)

• Three of digital health’s most prominent chronic care companies, Omada Health, Hinge Health, and Teladoc, chose not to apply to CMS’s Medicare ACCESS Model, and a new STAT News investigation (paywalled) digs into why. The core issue appears to be economics: the reimbursement rates CMS will pay don’t pencil out against what these companies currently earn per user. Omada CEO Daniel Perez was blunt, saying the model “will not improve outcomes, will not improve the experience, and will most certainly not reduce costs.” (H/t Mario Aguilar)

• A volume-versus-variability framework and the emerging CARA model together offer ACOs a practical roadmap for specialist engagement, with Zach Davis outlining both the analytics methodology and the CMS infrastructure being built around it. The framework maps specialties by region into four quadrants suggesting distinct strategies from referral steering to episode-based risk arrangements, with high-volume, high-variability specialists representing the clearest opportunity for meaningful savings. For nephrology, the implications are direct: nephrologists managing CKD and ESRD patients frequently land in that high-opportunity quadrant. CARA formalizes this approach for Global Risk ACOs beginning in 2028, but Zach's core point is that the underlying work, running episode-level analytics on claims data, benchmarking against risk-adjusted national data, and identifying spend drivers at the episode level, is work ACOs can and should be doing today. (H/t Zach Davis)

  

TECH-ENABLED CARE

• A new Axios piece covers the Peterson Health Technology Institute's report on administrative AI, highlighting a shift in how investors are approaching diligence on these tools. The core question is no longer whether AI saves time in the back office, but whether deployment is actually reducing system-level costs and improving patient outcomes. PHTI's Executive Director, Caroline Pearson, notes that answering that question requires measuring the right things and addressing misaligned incentives, not simply automating workflows that were already broken. (H/t Caroline Pearson)

• Virta Health’s nutrition-based treatment produced significant, lasting reductions in nearly all markers of systemic inflammation (19 of 21) in a new peer-reviewed study published in Endocrine Research, including a 35% improvement in hsCRP at one and two years. Unlike FDA-approved drugs that target inflammation narrowly, Virta’s individualized dietary approach achieved broad-spectrum effects across multiple markers simultaneously. The findings add to a growing body of published outcomes spanning glycemic control, liver disease, cardiovascular risk, and now inflammation, suggesting a single intervention may address several root drivers of chronic metabolic disease. (H/t and congrats, Sami Inkinen and team)

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Community

• Lewisburg nephrology teams celebrated home dialysis success with a patient-centered event at the historic Campus Theatre, bringing together patients, care partners, and a multidisciplinary care team to highlight the human side of kidney care. The event emphasized patients and their families as the drivers of their own health journeys, with clinicians intentionally stepping back to let patient voices lead. A meaningful moment for nephrology fellows to see team-based, patient-centered care modeled in practice. (H/t Maria Camila Bermúdez)

• Over 100 nephrologists and practice leaders gathered in Atlanta for the RPA and ISGD Clinical Trials Bootcamp, united around a vision of embedding research as a core component of community nephrology practice rather than an optional add-on. The tone was set early by program chair Katie Westin Kwon: "We are no longer just in the business of providing dialysis, the name of the game is remission." Practical sessions covered everything from budget planning and operational infrastructure to staff investment and site-building strategy, with a consistent message that starting small, starting simple, and learning from study monitors is the fastest path to a sustainable research program. A timely reminder that when community practices participate in trials, they expand access to emerging therapeutics for the patients who need them most. (H/t ISGD and Sarah Dixon Stump)

• A recent HCPLive roundtable with leading nephrologists captures both the progress and persistent gaps in APOL1-mediated kidney disease, now 15 years after the genetic discovery that reshaped our understanding of kidney disease risk in populations with West African ancestry. Roughly 14% of African Americans carry the high-risk genotype, yet 80% of carriers will never develop kidney failure, making prediction the central unsolved problem. Targeted therapies are advancing through late-stage trials, but guideline gaps and payer coverage remain equity challenges that could limit who benefits when approvals arrive. (H/t Pranav Garimella)

• The FDA's recent rejection of REGENXBIO's gene therapy application is part of a broader pattern signaling that the evidentiary bar for advanced therapeutics is rising, and a new BioSpace opinion piece by Revalia Bio's Jenna DiRito argues the core problem is structural. Late-stage failures in gene and cell therapy often trace back to early-stage evidence built on animal models and simplified systems that don't fully capture human biology, creating uncertainty that compounds through the entire development pipeline. She points to emerging tools including organoids, organ-on-a-chip platforms, and ex vivo human tissue models as ways to integrate human-relevant data earlier and reduce late-stage surprises. (H/t Jenna DiRito, PhD)

• Actor Jesse Eisenberg and NYU transplant surgeon Dr. Robert Montgomery joined the Dr. Mike show for a wide-ranging conversation on kidney donation that has already drawn 350,000 views. Eisenberg shares his personal decision to donate a kidney and the thinking behind it, while Dr. Montgomery covers the 90,000-person transplant waitlist, the donation process, his own heart transplant, and the frontier of xenotransplantation. A rare piece of mainstream media that makes the case for living donation in an accessible, human way worth sharing well beyond the nephrology community. (H/t Macey Levan)

GUIDELINES

• KDOQI has published its US commentary on the 2025 KDIGO Clinical Practice Guideline for IgA Nephropathy and IgA Vasculitis, offering implementation context for American clinical practice alongside the international guideline statements. The commentary emphasizes risk stratification as a foundation for treatment decisions and highlights the expanding menu of disease-modifying agents now available to slow IgAN progression. With multiple trials of novel therapeutic mechanisms still ongoing, the work group acknowledges the real challenge of selecting appropriate agents for a heterogeneous disease. (H/t Tarek Abbas)

• KDIGO has published the report from its 2025 Green Dialysis Controversies Conference in Kidney International, focusing on how to reduce the environmental footprint of one of medicine's most resource-intensive treatments. Discussions centered on innovation in dialysis technologies, clinical practice, and health systems, with patient perspectives playing a central role in underscoring that sustainability and quality of care are not competing priorities.

• The International Society of Nephrology has released three one-page clinical cheat sheets designed to support primary care professionals in identifying and managing kidney disease earlier, covering early CKD identification, cardio-kidney-metabolic health, and kidney replacement therapies including conservative management. Practical, shareable tools for the frontline clinicians most likely to catch kidney disease before it progresses.

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Events Calendar

• Kidney Innovation Conference (May 20-21 / Washington DC)

• Vascular Access Society of the Americas (May 20-22, Salt Lake City)

• European Renal Association (June 3-6, Glasgow)

• Korean Society of Nephrology (June 11-14, Seoul)

• American Transplant Congress (June 20-24 / Boston, MA)

• BIO Conference (June 22-25 / San Diego, CA)

• GlomCon Hawaii (August 3-7, Maui)

• Mayo Nephrogenetics Update (December 4-5 / Jacksonville, FL)

• NephCure Support Groups (Ongoing)
  
  

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Jobs

• Nephrologist (Miami, FL) — Kaüna (Say hello!)

• Director, Clinical Education & Competency — Monogram

• Associate Director, EHS (Arkansas) — Vantive

• Manager, Strategic Initiatives (Nashville, TN) — Monogram

• Clinical Research Associate — Ardelyx

• Manager, Market Insights (Rare Disease) — Travere

• Director, Marketing (GCS Kidney) — Vertex

• Regulatory Affairs Strategy Director — AstraZeneca

• Director, Procurement & Sourcing — Akebia

• Senior Director, Network Development — Interwell

• Senior Manager, Biobank — Amgen

• …plus hundreds more at jobs.signalsfs.com
  

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Your curated list of high priority open roles across the kidneyverse, delivered straight to your inbox every two weeks. This week features senior roles across biotech, value-based care, and kidney care operations, with multiple openings at Akebia, Travere, and Vertex as kidney disease pipelines continue to grow.

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At A Glance

• Chief of Staff, Research (Biogen)

• Director, Procurement & Sourcing (Akebia Therapeutics)

• Manager, Strategic Initiatives (Monogram Health)

• Associate Director, EHS (Vantive)

• Senior Research Associate (Renasant Bio)

• Market Research Associate Director (Travere Therapeutics)

• Transplant Financial Coordinator (Renown Health)

• Clinical Account Manager (Travere)

• Senior Director, Technical Operations – Biologics (Akebia)

• Epic Professional Billing Analyst (Interwell Health)
  
  

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Open Roles

• Biogen is hiring a Chief of Staff, Research (Cambridge, MA, On-site) to serve as a strategic thought partner and operational anchor for the Head of Research at one of the world’s leading biotechs. This role advises at the EVP/C-suite level, synthesizes complex decisions across a matrixed organization, and requires deep experience across biotech, pharma, or top-tier consulting. Apply here.

• Akebia Therapeutics is hiring a Director, Procurement & Sourcing (Cambridge, MA, On-site) to lead all sourcing, contracting, and requisition-to-pay operations for a commercial-stage kidney disease biotech. Reporting to the CFO, the role spans clinical trial supply, commercial product support, and vendor negotiations across MSAs, SOWs, and NDAs. Ten-plus years of life science procurement experience required. Apply here.

• Monogram Health is hiring a Manager, Strategic Initiatives (Brentwood, TN, On-site) to partner with the Chief of Staff on high-priority enterprise initiatives, owning discrete workstreams and driving structure and execution across the organization. The role is designed for candidates with a background in top-tier consulting or investment banking who are comfortable operating with limited oversight in a fast-moving healthcare environment. Apply here.

• Vantive is hiring an Associate Director, Environmental Health & Safety (Dublin, Ireland, Remote) to shape and lead global EHS strategy across sites in Europe, the U.S., LATAM, and Asia. A senior leadership role for a kidney care medtech company building out its global operational foundation following its separation from Baxter. Apply here.

• Renasant Bio is hiring a Senior Research Associate (Berkeley, CA, On-site) to execute high-resolution protein and nucleic acid analyses supporting a kidney disease pipeline built around novel small molecule programs. The role requires hands-on biochemistry expertise and prior biotech industry experience. Apply here.

• Vertex Pharmaceuticals is hiring a Market Research Associate Director (Boston, MA, Hybrid) to generate commercial insights shaping strategy and launch readiness for its genetic kidney disease portfolio, including programs targeting APOL1-mediated kidney disease. The role sits within the North America Forecasting, Analytics & Insights team and requires 8-plus years in biopharma market research or analytics. Apply here.

• Renown Health is hiring a Transplant Financial Coordinator (Reno, NV, On-site) to serve as a financial advocate for transplant patients and families, managing insurance benefits, authorizations, and billing coordination across the full transplant continuum of care. Apply here.

• Travere Therapeutics is hiring a Clinical Account Manager (Manchester, NH, Remote) to bring Filspari to nephrologists treating rare glomerular disease across a New England territory. The role requires 8-plus years of specialty pharma or biotech sales experience and deep comfort calling on prescribers of high-value, complex products. Apply here.

• Akebia Therapeutics is hiring a Senior Director, Technical Operations – Biologics (Cambridge, MA, On-site) to lead end-to-end CMC strategy for AKB-097 from clinical development through commercialization, building and managing Akebia’s external biologics manufacturing network. Requires 12-plus years of progressive biologics experience and a track record advancing programs through late-stage trials and BLA submission. Apply here.

• Interwell Health is hiring an Epic Professional Billing Analyst (Remote) to own configuration and operational integrity of Epic’s professional billing workflows for a leading kidney care management company. Requires Epic Resolute PB and Charge Router certifications and deep hands-on experience in revenue cycle workflows at scale. Apply here.

Every one of these roles is a chance to move the needle on kidney health. We hope you find yours. More roles added weekly at jobs.signalsfs.com.

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In Part One of this series, Bill Fitzsimmons and Kevin Fowler helped define the moment and unmet need in transplant medicine. We talked about why progress has stalled and how changes in regulatory pathways could unlock new investment and treatment options for patients. This conversation builds on that foundation.

Q&A

Let’s start with introductions. What is your background and connection to this space?

I’m Deirdre Sawinski, an associate professor of medicine and transplant nephrologist at Weill Cornell. I’m also a researcher, epidemiologist, and clinical trialist. What drew me to this field, and what’s kept me here, is really the people. I care deeply about the patients I serve. What I love about research is that I can go to clinic, see something I don’t fully understand, and then go back to the data to try to answer it. Why didn’t that kidney last? What could we have done differently? That loop between patient care and discovery is what keeps me going.

I’m Sejal Patel. I’m a physician by training and now work in renal therapeutics in industry. I’ve also lived this personally. I had a kidney and pancreas transplant 17 years ago, and then a second kidney five years ago. That second graft failed due to nephrotoxicity. That experience has really shaped how I think about the gap between innovation and long-term outcomes. Living on both sides, clinical and patient, you see things very differently. There’s so much opportunity to improve outcomes, but there’s also a real disconnect between what we measure and what patients actually go through.

I’m Steve Rizk, Senior Vice President of Medical Affairs at Veloxis. I’ve been in the industry for about 24 years, much of that in transplantation. Drug development in transplant is not for the faint of heart. Short-term outcomes are very strong, but long-term outcomes have remained relatively stagnant. A lot of my work has focused on trying to change that trajectory, whether that’s aligning on endpoints, working with regulators, or making the case internally to continue investing in this space.

What are we missing when we talk about outcomes in transplant?

Patel: From a patient perspective, we’re missing a lot. Yes, short-term outcomes are strong. But long term, patients are dealing with infections, malignancies, cardiovascular issues, and the side effects of immunosuppression. Those things don’t always show up cleanly in clinical endpoints, but they shape daily life in a major way. Something like diarrhea might not sound like a big deal clinically, but I’ve seen patients who can’t leave their house because of it. That leads to dehydration, hospitalizations, and ultimately impacts the graft itself.

For me personally, the toxicity was very real. I had severe bone loss. I broke my ankle and my knee multiple times. I’ve had joint replacements. These are life-altering complications, even if they don’t show up as primary endpoints in trials. There’s a real gap between the science and the lived experience.

Sawinski: I think that’s exactly right. And to build on that, we’ve been using essentially the same regimen, tacrolimus and mycophenolate, for over two decades.2 We don’t treat cancer in 2026 the same way we did in 2001. We don’t treat heart disease or diabetes the same way. So why should transplant be different? At some point, “good enough” becomes a barrier.

Rizk: And the data supports what you’re describing. In a recent survey of over 10,000 transplant recipients, 92% reported experiencing adverse side effects on a regular basis. One quarter of those patients skipped doses due to side effects. That’s a clear signal that what we have today isn’t enough.

Figure: Side effect frequency (left panel) and overall burden (right panel)3

Why has transplant lagged behind other areas of kidney disease?

Sawinski: A big part of the challenge is regulatory. If you want to bring a new drug to market, you still have to compare it against the current standard using endpoints like acute rejection and one-year graft survival. The problem is those outcomes are already very good—greater than 95% graft survival at one year. That means you need thousands of patients to show a difference, which makes trials incredibly difficult and expensive. In many cases, innovation gets stalled before it even starts.

Rizk: From a development standpoint, you need two things: a regulatory pathway and a treatable population. The population is there. The challenge is the pathway. Without agreement on endpoints like iBox or other surrogate markers, it’s very difficult to design feasible trials. And without that, companies hesitate to invest.

Patel: There’s also a mindset component. There’s a perception that we already have something that works, so why take the risk of changing it. And in transplant, that risk feels higher because patients have been given this life-saving organ. That makes people cautious about testing new approaches, even when long-term outcomes clearly need improvement.

How should we be thinking differently about endpoints and success?

Sawinski: If we’re going to incorporate patient-reported outcomes (PROs), we have to do it rigorously. That means validated instruments and agreement across the field. But beyond that, we need to rethink what success actually means. Are we willing to accept a 10% increase in acute rejection if it leads to a 50% improvement in quality of life? Are we willing to accept a 5% reduction in GFR for a 25% improvement in symptoms or tolerability? Those are real tradeoffs. And I think sometimes, from a clinical or regulatory perspective, we default to objective measures like creatinine or rejection rates.

But patients may value those tradeoffs very differently. Some patients might say, “I’m okay living a slightly shorter time if I can live better during that time.” And that’s not a crazy perspective. That’s a real human decision.4

Patel: I completely agree with that. I think the key is involving patients earlier in the process so they can help define what success looks like. Not just as an afterthought, but from the beginning. When you start prioritizing things like tolerability, long-term toxicity, and quality of life, you begin to acknowledge that one size doesn’t fit all. That’s where personalization really starts to matter.

Rizk: And from a development perspective, those endpoints have to be measurable and attributable to the therapy. That’s the challenge. But we’ve seen this work in other areas. IgA nephropathy is a great example, where proteinuria was accepted as a surrogate endpoint. That opened the door for innovation. We need something similar in transplant. It doesn’t have to be perfect, but it has to be good enough to move the field forward.

Figure: Patient-Reported Outcomes in the Regulatory Balance

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What would meaningful innovation actually look like?

Patel: For patients, I think it’s really about choice. If you look at oncology, there are multiple therapies and approaches. Patients and physicians can choose what fits best. In transplant, we don’t really have that. We have a few options, and they’re often used in very specific scenarios rather than tailored to the individual.

For example, we’re using nephrotoxic drugs in patients who already have a transplanted kidney. Patients ask about that, and it’s a fair question. We just don’t have enough alternatives.

Sawinski: Yes, I get that question all the time. Patients ask, “Why are you giving me something that’s toxic to my new kidney?” And the honest answer is that this is the best we have right now. But in other areas of medicine, we’re moving toward precision. In cancer, we genotype tumors and target therapy. That’s where transplant needs to go.

Rizk: And part of the challenge is that even years after transplant, many patients don’t have their regimen adjusted. In that same survey, about one in four patients reported never having their therapy changed six and a half years after transplant, despite most experiencing side effects. That’s not because clinicians don’t want to change therapy. It’s because there aren’t enough viable alternatives.

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How do we make clinical trials more accessible and relevant to patients?

Patel: Trust is a big factor. Patients trust their physicians, but they also trust other patients. Hearing from someone who has actually participated in a trial can make a huge difference. Patient advocates, testimonials, even short videos explaining the experience, those things help. There are also practical barriers. People are busy. They have jobs, families, and other responsibilities. Making trials more accessible through virtual visits or remote monitoring could go a long way.

Sawinski: We also have to acknowledge that trial participants don’t always reflect the broader population. There’s historical mistrust, there are time constraints, and for many people, transplant is just one part of their life, not something they want to center everything around again. We need to design trials that fit into people’s lives.

Rizk: There are definitely more opportunities for remote participation than we sometimes assume. The pandemic forced us to think differently, and there are lessons there that we haven’t fully carried forward. We’re starting to incorporate patient feedback earlier in protocol design, which helps, but there’s still more we can do.

Final thoughts: what needs to happen next?

Rizk: I’ll highlight three things. First, Amy Silverstein’s work.5 She made it very clear that while organ donation is miraculous, transplant medicine still has a long way to go. Second, the “gratitude paradox.” Patients are understandably grateful for their transplant, but that gratitude can make it harder to speak up about ongoing challenges and unmet needs. Third is advocacy. That’s how we move forward. We need to carry the voices of patients, whether that’s individuals like Dr. Patel or the 10,000 patients who participated in the survey, and make sure they’re heard by regulators, clinicians, and industry.

Sawinski: I think that’s exactly right. Patients should speak up, to their physicians, to policymakers, to anyone who will listen. That’s how unmet needs become visible. And from our side, we need to keep those conversations front and center. That’s how we push for change.

Patel: What gives me optimism is that all of these perspectives are starting to come together. The science, the clinical need, and the patient voice are finally converging. That wasn’t happening even a few years ago. We’re starting to build momentum. And if patients, clinicians, and industry continue to work together, that’s where real change will come from.

###

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Continue learning

• Too Grateful to Complain? A guest essay by Karin Hehenberger MD, PhD on why organ transplantation lags behind oncology in innovation and public voice.

• Life on Immunosuppression. The largest survey of its kind reveals the daily toll of transplant drugs, and the case for rewriting the playbook through advocacy, policy, and innovation.

• Unboxing the next frontier in transplant medicine. A Signals brief on the novel iBox score; how it works; and why it might change the course of decision-making and drug development in kidney transplantation.

• Mapping the Xeno Immune Response With PITOR’s Erwan Morgand and Alessia Giarraputo. How researchers from Paris Transplant Group, NYU, and MGH are using multimodal diagnostics to uncover the earliest immune response signatures in pig-to-human xenotransplantation.

• Signals KOLs with Dr. Ben Hippen, a conversation about IOTA, incentives, and how to build a transplant-inclusive kidney care model.

Refer a friend

Last week I attended the two-day AI in Nephrology meeting at UC San Diego. One session in particular stuck with me, Dr. Rupesh Raina’s talk on pediatric nephrology.1 It sent me down a bit of a rabbit hole this weekend. The more I read and the more I listened, the clearer something became. Pediatric kidney disease is fundamentally different from what we spend most of our time discussing in adult nephrology. It rarely shows up in the broader kidney care conversation, but it should.

In this brief, we take a closer look at what we know today, where the gaps are, what’s starting to change, and what comes next.

It starts differently

From the outside, it is easy to miss how different kidney disease looks in children. The dominant drivers are congenital and genetic. Congenital anomalies of the kidney and urinary tract (CAKUT), hereditary nephropathies, nephrotic syndrome, and rare glomerular diseases shape the landscape early in life. These conditions follow patients for decades, but the systems around them were largely built with adult disease in mind.

As one clinician told me:

As patients age, the specificity that defines pediatric care often gives way to broader CKD labels, even though the underlying biology and risk profiles remain distinct. A highly classified system early in life becomes more generalized at the point where long-term risk is accelerating.

CAKUT alone is the leading cause of CKD and kidney failure in patients under 30. That should anchor how we think about this population.2

Where the system falls short

The gaps show up most clearly at the point where discovery is supposed to translate into care. In adult CKD, therapies like SGLT2 inhibitors have quickly become foundational, supported by large trials showing meaningful renal and cardiovascular benefit. In children, that same progress has been slower to take hold. Pediatric populations were excluded from early studies, and the underlying disease looks different enough that results cannot simply be carried over.3

Most pediatric CKD is driven by congenital and non-glomerular disease.4 Progression is more variable, proteinuria is less consistent, and traditional endpoints are harder to apply. Safety considerations also shift: what looks manageable in adults raises different questions in children, from hydration to growth and development. The result is a familiar pattern. By the time therapies reach clinical practice, the evidence base in children is thinner, and access follows more slowly.

A July 2023 workshop convened by Kidney Health Initiative and NephCure on pediatric CKD and SGLT2 development offers a window into how the field is working through this transition in practice. The questions raised are simple, but they map directly to the challenges of extrapolation, trial design, and feasibility.

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This is starting to show up in real trials. The EMPA-KIDNEY Kids trial is now underway, designed to evaluate empagliflozin in children with CKD across safety, dosing, and early efficacy signals. It is a major step forward, and it also highlights how much coordination, infrastructure, and time are required to bring therapies to this population.

The same pattern shows up beyond therapeutics. In dialysis, equipment is still not consistently designed for children, despite well-known differences in physiology and scale. In acute care, pediatric AKI remains an area of active study, a core focus of Dr. Raina’s work and presentation, with growing use of predictive models and biomarkers but fewer standardized approaches to early intervention.5 Across settings, the underlying issue is consistent. The science is advancing, but the systems needed to deliver it are still catching up.

That gap is now getting more deliberate attention across research, policy, and clinical development. It requires bringing the right groups together to align on data, endpoints, and how to move therapies forward.

What is starting to change

Earlier this month, KidneyFuture convened a summit at the FDA on congenital kidney disease and trial readiness. It brought together patients, parents, clinicians, researchers, industry, and regulators around a practical question: how to ensure children born with CAKUT benefit from both the scientific progress and therapeutic wave already underway in CKD.6

As pediatric nephrologist and trialist Dr. Jennifer McKenzie shared, the challenge is not a lack of need, but a lack of fit. Children with congenital kidney disease do not map cleanly to adult populations. There is no clear analogue for extrapolation, disease trajectories vary widely, and it remains uncertain which endpoints best reflect long-term benefit.

One of the clearest takeaways was a growing alignment around underlying biology. Despite differences in presentation, CAKUT appears to converge on a common pathway. Reduced nephron number leads to compensatory hyperfiltration, where the remaining nephrons work harder to make up for fewer filters. Over time, this drives progression along familiar CKD pathways. That framing matters because it creates a bridge to therapies that already exist or are being developed in adjacent populations.

From there, the discussion moved into application. Several therapeutic pathways already being explored in adult CKD and rare kidney diseases may be relevant in congenital populations. The challenge is less about whether these therapies could work and more about building the conditions to test them.

That is where the focus of the summit landed. Defining target populations, developing inclusion and exclusion criteria, identifying meaningful surrogate endpoints, and assembling the data and infrastructure needed to support trials. A substantial body of data already exists in CAKUT, but it has not yet been organized through a drug development lens. In many cases, these patients are present in broader CKD datasets but not identified as a distinct, high-risk subgroup.

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Efforts like the TRACK Consortium (Therapeutic and Regulatory Science Advancement in Congenital Kidney Disease) are starting to take shape around this work. Convened by KidneyFuture, TRACK brings together patients and families, clinicians, researchers, registries, industry, and regulators to clarify natural history, distinguish evidence from uncertainty, and develop shared, trial-ready frameworks in a pre-competitive setting.

That urgency is also reflected in how KidneyFuture itself was built. As founder Vincent Ko shared recently, the organization emerged from lived experience, shaped by the isolation and uncertainty families face and a desire to move from waiting to acting. The goal is straightforward. Connect patients, care, and science in a way that accelerates progress.

A recent commentary in Pediatrics offers a useful lens on how the field has evolved. Early work in the mid-20th century focused on describing disease and managing complications, often with limited effective therapies and high mortality. Over time, tools like the Schwartz equation made it possible to identify CKD early and follow progression, and later guidelines brought more structure to how pediatric CKD is identified and managed.7 What stands out is how much of pediatric nephrology has been built around observation, measurement, and standardization. The next phase is about connecting that foundation to mechanism and intervention.

In parallel, the science is starting to resolve what has long been treated as a black box. In idiopathic nephrotic syndrome, the most common glomerular disorder in children, attention is shifting toward the kidney’s filtration barrier.8 The podocyte and its key structural protein, nephrin, are becoming central to how we understand disease.

Figure: A closer look at the podocyte filtration barrier, where nephrin maintains structure and disruption leads to protein leakage. 9

Emerging evidence suggests that in some patients, antibodies target nephrin and disrupt this barrier. That disruption leads to the protein leakage that defines the disease. Seeing it this way starts to connect structure, mechanism, and outcome in a more direct way.

That shift is beginning to show up in treatment. Therapies like rituximab and obinutuzumab are targeting the immune pathways involved, and early work on plasma cell–targeting approaches (e.g. CD38) suggests there is still room to refine how these patients are treated.

What the field says it needs

What clinicians and researchers say they need reflects both ambition and constraint. In the Kidney Health Initiative’s recent pediatric research priorities survey, SGLT2 inhibitors rose to the top, driven by the momentum these therapies have created in adult CKD. Hemodialysis equipment ranked near the top of the list, a reminder that foundational infrastructure remains an active challenge as well.10

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Dr. Raina’s work on pediatric AKI fits into this same dynamic. The vision is clear: predictive models embedded in clinical workflows that identify risk earlier and guide intervention. Early results are encouraging, including models that can predict steroid-resistant nephrotic syndrome at disease onset with high accuracy.11 The limiting factor is less about model performance and more about the surrounding system. Small datasets, variation across centers, and limited validation cohorts continue to constrain how quickly these tools can move into practice.

The through line

Children with kidney disease grow into adults living with the long-term consequences of those early conditions. The decisions made in pediatric care shape trajectories that extend across decades. That connection creates an opportunity to intervene earlier, with more clarity around biology and risk than is often possible later in life.

At the same time, there is a clear imbalance in attention and resources. One parent shared that while pediatric nephrology remains underrepresented in drug development, the clinicians in the field are among the most engaged and committed they have encountered. The limiting factor is less about effort and more about funding and focus. With more support, the path to new therapies may be shorter than many assume.

What stood out this week is a field that is starting to align around that opportunity. The pieces are there: data, biology, early signals from new therapies, and a growing push to make trials feasible. The next phase will depend on how well those pieces come together.

If this resonates, share it and weigh in. Where do you think pediatric nephrology is being overlooked, and what needs to change?

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I want to thank everyone who reached out to share their perspective while I was working on this piece. The work happening across this field to advance care and give children a voice is clear. Thank you all for what you do.

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In Part One, we argued that kidney disease is medicine’s earliest warning system, one the system has spent decades ignoring in favor of treating its most expensive consequences. The natural question that follows is where structural change will actually occur. These gaps persist because the system rewards what happens later, not earlier. That structure has held for decades and produced durable businesses built around kidney failure as the endpoint. Changing it requires shifting where value accrues.

The opportunity sits beyond the current silos. Science has advanced significantly over the past decade. Therapies now exist that can slow or stop disease progression. Yet only a small share of eligible high-risk patients are on inexpensive therapies with proven renal and cardiovascular benefits, and two thirds of new kidney failure cases are driven by diabetes and hypertension, conditions that are detectable and manageable long before kidney function declines.

The gap between what we know and what we do is a systems problem, and systems problems have a specific architecture. They live at the handoffs between domains, where information, clinical judgment, treatment, and accountability must transfer from one part of the system to the next. Those handoffs are where the kidney care system breaks down, consistently and predictably, because it was never designed to make those transfers work.

Mapping the Handoffs

We think of the chronic care system as a circle rather than a pipeline. Signal becomes decision, decision becomes action, action should produce accountability, and accountability in a well-designed system feeds back into better signal. Each stage depends on the one before it, and each transition between them is a place where something can go wrong. In kidney and cardiometabolic care, things go wrong at all four.

Figure: The Four Bridges of the CKM Care System

Keen eyes will notice payment sits outside our four stages. We treat it as the terrain every stage operates within. Today that terrain is fragmented, misaligned, and constraining. As financial models evolve, solutions that account for that terrain will endure. The companies worth watching are building bridges that can stand within it and, over time, begin to reshape it.

The companies closing these gaps rarely fit neatly into “kidney” care, but their impact will be felt here. Some of the strongest proof points come from cardiovascular and metabolic care, where this kind of infrastructure is already in place and delivering results. Kidney care is building its own, and the pace is accelerating.

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Bridge One: Signal to Decision

The kidney is medicine’s earliest warning system, which makes the first bridge the most fundamental one. A creatinine that ticks upward, protein spilling into urine, a potassium level drifting toward a dangerous threshold. These signals precede catastrophic cardiovascular events by years, sometimes decades, and they are measurable with tools that already exist. The problem is more than detection. It is what happens after detection occurs, which in most cases is still too little.

Basic kidney screenings recommended for high-risk patients are ordered less than half the time in primary care. When results arrive, they enter workflows already crowded with data, leaving little time for interpretation. A risk score sitting unread in an inbox never becomes a clinical signal. The challenge is building infrastructure that makes data actionable at the point of care.

Datavant has demonstrated what that connective infrastructure can look like at scale, linking fragmented patient-level data across disconnected systems, including labs, pharmacy records, claims, and EHR data, into a coherent picture that would otherwise be impossible to assemble.1 For kidney and cardiometabolic populations, where a single patient’s relevant signals are distributed across nephrology, cardiology, endocrinology, primary care, and pharmacy records that were never designed to talk to each other, that kind of interoperability is a prerequisite for individualized care. A new generation of companies is building toward that gap in kidney and cardiometabolic care specifically. Some are applying AI to standard lab data to generate earlier and clearer grounds to act, giving clinicians a reason to intervene before the window closes.2 Others are combining population-level screening with predictive analytics to identify patients before disease advances to the stage where the system finally pays attention.3 Still others are developing continuous monitoring tools that capture signals currently invisible between clinic visits, signals that carry serious cardiovascular risk when they go undetected and that no current standard of care is designed to track.4

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Bridge Two: Decision to Action

The evidence base for treating kidney and cardiometabolic disease earlier is stronger than ever. RAAS and SGLT2 inhibitors, along with GLP-1 receptor agonists, are supported by some of the most robust trial data in modern medicine, and the guidelines reflecting that evidence are widely available to clinicians. Only fifteen percent of eligible high-risk patients are currently on SGLT2 inhibitors.5 The gap sits between clinical decision and delivered intervention. That distance remains wide, and much of the system underestimates it.

Fragmentation is the structural cause. Nephrology, cardiology, and endocrinology evolved as separate disciplines, each organized around its own workflows, its own incentives, and its own answer to the question of whose patient this is. No single part of the system owns the full trajectory of risk, which means decisions made in one setting routinely get lost before they reach the patient in another. The prescription that never gets filled, the referral that never gets followed up, the treatment plan that made clinical sense but ran into a formulary barrier no one had time to navigate. These are routine care gaps for kidney patients moving through a fragmented system.

Specialty-specific care infrastructure has already attracted billions in capital, as investors recognized that building around a single high-cost population, with the right clinical model and payment alignment, could drive meaningful outcomes at scale.6 Value-based kidney care has been one of the clearest expressions of that thesis, with a generation of companies demonstrating that coordinating care around a defined population can work clinically and operationally. What that capital built is a layer of infrastructure that now exists across the kidney ecosystem and is beginning to expand its reach to a majority of diagnosed CKD patients. Kidney entities are incorporating cardiac and metabolic populations. Cardiovascular platforms are recognizing kidney disease as a comorbidity they can no longer manage around. Large payers are asking these entities to take on more risk for more complex patient populations. The category has matured into the operating environment within which the next generation of companies will need to build, partner, and compete. Understanding that environment—its players, contracts, and constraints—is a prerequisite to investing in this space.7

Bridge Three: Action to Accountability

Systems of care are made up of a vast web of possible actions: delivering treatments, writing prescriptions, and appointment reminders to name a few. But what almost never follows is a retrospective accounting of whether any of it worked as planned. The system produces documentation in abundance, but documentation alone is a far cry from accountability. Accountability means the answer changes what gets funded, what gets contracted, and what gets done differently next time. In practice that means a payer or practice renewing a contract with a partner that demonstrably reduced hospitalizations, or a health system redirecting resources toward an intervention that the data showed actually worked, or a nephrologist changing prescribing behavior because the outcomes of the last hundred patients told them something their training did not. That connection, between what was done and whether it mattered, is precisely what fee-for-service medicine was never designed to make.

Simply put, the current payment architecture has little structural need to make that connection. Volume is the metric that matters, and whether the action produced the intended result is, by design, someone else’s concern. The people delivering care within that system are often doing exceptional work, but the system itself was never built to follow-up or follow-through.

Turquoise Health has built a model in adjacent parts of the system that illustrates what accountability through transparency can accomplish, making hospital pricing and contract data visible in ways that create genuine pressure toward better performance.8 The dialysis contracting market is among the least transparent in American healthcare, and the gap between what that market costs and what it delivers in outcomes is one of the most visible disconnects in the downstream CKM system. Arbital Health represents the archetype that Bridge Three needs most in kidney care specifically: outcomes infrastructure whose business model is only viable if the clinical action produced the intended result, and that therefore has a durable structural reason to care whether it did.9 That alignment of financial and clinical consequence is precisely what fee-for-service was never designed to produce, and what value-based care has promised for years.

Bridge Four: Accountability to Signal

This bridge determines whether the other three add up to a system or remain a collection of parallel interventions.

A learning system measures outcomes and feeds them back into earlier detection, more effective intervention, and smarter allocation of resources. It is a reporting system, and the distinction matters enormously for a disease like kidney failure, where the window for intervention is long but the system has historically been structured to act only after that window has closed. Fee-for-service medicine was never designed to close this loop because there was no incentive to ask whether last year’s intervention changed this year’s trajectory. Value-based care creates that incentive in principle, but the infrastructure to act on it remains largely unbuilt across most of the CKM system.

Truveta demonstrates how outcomes data from real clinical practice can feed back into evidence that shapes guidelines, prescribing behavior, and resource deployment across a health system. Drawing on more than five years of patient history across hundreds of hospitals, it generates real-world evidence at a depth and scale beyond traditional research. An equivalent layer of infrastructure for CKM populations remains incomplete. Relevant data sits across nephrology practices, dialysis centers, primary care offices, and cardiology clinics, each operating in separate systems. Bringing that data into a unified picture of what is working, for whom, and under what conditions remains a core opportunity.

Century Health is building toward that real-world evidence layer for kidney and cardiometabolic populations specifically, translating clinical data into the kind of evidence that can change practice at scale rather than sit in a research paper that takes years to influence a guideline.

This bridge closes the circle. It allows the system to learn from its own outcomes and apply those lessons to earlier decisions. Without it, the system repeats the same failures at the same moments. Improvements at the other three bridges stay local, fragile, and unable to compound into system-level learning.

A Field in Motion

Capital is beginning to follow the same realization that reshaped cardiovascular care: that the highest-leverage opportunities sit upstream, where risk can still be identified, managed, and changed. The four bridges are where that opportunity lives today.

The capital flowing into this space tells two distinct stories. The first is validation. Over the past two years, more than twenty billion dollars in kidney-related mergers and acquisitions – largely pharma consolidating therapeutic assets in rare kidney diseases – confirmed that the underlying science has matured and that the market is paying attention. These are late-stage affirmations of mechanisms and evidence that took decades to develop.

The second story is where our opportunity lives. Alongside those exits, more than three billion dollars has flowed into early-stage companies working across care delivery, diagnostics, software, and data infrastructure, building the connective tissue that links the system together and extends beyond what pharma exits can provide. Through Signals, we’re tracking more than one hundred fifty companies across the kidney and cardiometabolic ecosystem. That landscape points to a field at a genuine inflection point: new platforms and tools taking shape, and established players reorienting around upstream intervention and the integrated care models the CKM era demands.10

While exits validate the market, early-stage capital reinforces our belief the work is far from done. What remains largely unbuilt is the layer that connects them, the bridges that turn therapeutic breakthroughs into demonstrable outcomes for the patients who need them most. That is the work of this decade, and it is still early.

The Bright Frontier

In 1827, a physician named Richard Bright published a series of case studies from Guy’s Hospital in London that changed the course of medicine. Through careful observation of patients with edema, he identified albuminuria as a defining marker of kidney disease and described a connection between kidney failure and cardiac enlargement. He is remembered as the “father of nephrology,” but he was also describing the cardio-kidney continuum nearly two centuries before the field gave it a name.

The frontier he opened is still being mapped. Gene therapies designed to halt progression, bioengineered kidney tissue as an alternative to a transplant waitlist that will never be long enough, RNA medicines targeting the underlying biology of cardiometabolic disease, and xenotransplantation moving into early human trials. Across each of these frontiers, early-stage companies are doing the work that will define what kidney and cardiometabolic medicine looks like a decade from now.

The companies creating and capturing value in this space are building at the intersections. They turn fragmented signals into clinical decisions, coordinate care across specialties, and make outcomes meaningful across the system. That is where capital accelerates innovation, and where deep ecosystem knowledge and clinical expertise become a durable advantage. From early detection to organ failure and every point in between, a new category of companies will redefine care across the CKM continuum. This is where the next system will be built.

A Call for Collaboration

What this moment requires is not more validation that the problem is real, but coordinated effort to build the infrastructure that connects what we know to what we do. Across data, diagnostics, care delivery, and biology, the work ahead sits at the intersections.

At Bright Frontier, we are building an investment and convening platform to back the companies working across these bridges, and to bring together the operators, clinicians, patients, and policymakers needed to make those connections hold. The goal is to support the systems that allow insight to move, decisions to translate, care to reach patients, and outcomes to feed back into the system.

Signals Group is what makes that work possible. It provides a real-time map of where the system is breaking and where it is beginning to come together, informed by a community of more than 15,000 readers across 65 countries. That perspective shapes how we identify opportunities, test assumptions, and build our thesis. The work of closing these gaps and building these bridges will define the next phase of kidney and cardiometabolic care. We are building Bright Frontier to catalyze that future.

Where are the most important gaps? Which bridges matter most to you? The work is already underway. Our goal is to learn from the people doing it and to help accelerate what works.

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This series will continue with deeper looks at each bridge, perspectives from the people building them, and the science shaping what comes next. If you are working in these spaces, we want to hear from you.

We covered what the program is, why it matters, and how its mentor model helped them reach their personal goals as physicians. For a field navigating reimbursement pressure and shifting care models, understanding this side of nephrology is becoming just as important as practicing within it. Thanks for being here with us.

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Q&A

Let’s start with quick introductions. Tell us a bit about you and your practice.

Kinjel: I’m a private practice nephrologist outside Detroit. I trained in Michigan and stayed there. I’m about five years in and just made partner, so I’m right at that transition point where you start thinking more about the business and long-term direction of the practice. We’re a larger group. About 25 physicians, 15 APPs, and we cover over 1,300 dialysis patients. For me, the timing of this program was huge. I was going through partnership while also getting exposure to leadership and advocacy.

Aman: I’m in Southern Oregon. This is my first job out of fellowship, and I’m about four years into practice. We’re a smaller group. Six full-time nephrologists, a few part-time, covering around 400 ESRD patients across five dialysis units. We’re also the only nephrology group in this part of the state, so that was a big driver for me. I wanted to meet other nephrologists, compare experiences, and understand what’s happening nationally, especially on the policy side.

Romin: I’m in Durham, North Carolina, in a smaller private practice. Five full-time, one part-time nephrologist, plus APPs. We cover multiple dialysis units and a couple hospitals. We’re also in the backyard of a major academic system. That creates a different kind of pressure. You’re constantly thinking about how to stay independent and relevant. I’d had some exposure to RPA through my group, but this was my first time really being inside it. And honestly, probably got more out of it because of that.

What is the RPA Leadership Development Program?

Aman: At a high level, it’s about exposure. Exposure to policy. Exposure to advocacy. Exposure to how RPA operates. The idea is if you introduce nephrologists early in their careers to how these systems work, they’re more likely to stay engaged long term. And that ultimately helps both patients and practices.

Kinjel: We were paired with a mentor from RPA leadership right away. That part is underrated. You sit down early and say: what do I actually want out of this? Not just what RPA wants from me. Then there are three main touchpoints between the annual meeting in April, advocacy weekend in October, and board level meetings in the summer. And the board meetings are a big deal. Most physicians never see that side of things, and you’re sitting in the room where real decisions are actually being discussed.

Why did you apply? What were you hoping to get out of it?

Kinjel: For me, it was advocacy. During training, especially with COVID, we lost a lot of exposure. You’re just trying to survive clinically. Then you get into practice, and it’s the same thing. You’re grinding. Covering hospital, clinic, dialysis. You don’t stop to think about the system around you.

But that system is what determines whether your patients can access care. Telehealth is a perfect example. If coverage changes, my patients who live four to six hours away are suddenly impacted. I wanted to understand that layer better.

Romin: My motivation was a little more existential. Independent practices are getting squeezed. In our area, a lot of specialties have already been absorbed into large systems like Duke. We’re still independent, but for how long? So I wanted to learn how to think about innovation, strategy, and advocacy in a way that helps us stay competitive and continue to exist.

Aman: For me, it started with the business side. Once I became partner, I started seeing the numbers more clearly. Costs are rising every year. Staffing, operations, everything. Reimbursement hasn’t kept up. So effectively, margins are shrinking. That made me step back and ask: what are other groups doing? What’s happening at a national level? Are there levers we’re not pulling? And then there was also just a personal interest in policy. Being able to go to D.C., meet representatives, and see how decisions get made - that is a great experience and was definitely a draw.

What surprised you most about the experience?

Kinjel: That you can actually make a difference. It sounds simple, but I didn’t believe it before. You hear “advocate for your patients,” but it feels abstract. Then you’re in D.C., talking to staffers, discussing real legislation, and you see how things move. Then you realize, okay, this isn’t just symbolic. This actually matters.

Romin: I was struck by how few physicians get this experience. Most people are just too busy, which is understandable. But it means a small group ends up shaping a lot of the conversation.

How much do most nephrologists understand about policy today?

Kinjel: Honestly, not much. There were people who didn’t even realize telehealth coverage had changed.1 They’re just busy practicing, which is part of the challenge. These decisions are happening in D.C. that affect our patients and practices, whether we’re paying attention or not.

Romin: I agree, I think it’s limited to people actively involved in organizations like RPA. Otherwise, it’s not part of the day-to-day.

How does this tie back to the reality of running a private practice?

Aman: The economics are probably the biggest pressure. Over the last 20–25 years, reimbursement hasn’t kept pace with inflation. Meanwhile, costs keep rising, so you’re constantly trying to do more with less. And unless you understand policy and broader trends, you’re reacting instead of planning.2

Romin: And in some markets, you’re also competing with large systems that have very different resources. So the question becomes: how do you stay viable? How do you differentiate? That’s where this kind of exposure helps.

Kinjel: The biggest thing is mindset. It’s very easy to just grind. See patients, go home, repeat. But if that’s all you do, you’re not building anything, you’re just maintaining. Programs like this force you to zoom out. To think about your role not just as a clinician, but as part of a system. And the people who don’t adapt are going to struggle.

What would you say to early-career nephrologists considering this program?

Romin: Do it. Even if you’re unsure. You’ll learn something valuable, no matter what your long-term goals are. And you’ll meet people who genuinely want to help you grow.

Kinjel: I agree, it makes you better. As a physician, as a leader, and as an advocate for your patients.

What about residents or trainees thinking about pursuing nephrology?

Aman: Explore it properly. Most people don’t get enough exposure. And what they do see is often skewed to acute dialysis.

Kinjel: Exactly. In training, you mostly see the sickest patients. The ones who keep getting admitted. That’s not the full picture. If you really want to understand nephrology, you have to go outpatient. See a CKD clinic and home dialysis unit. See transplant patients. That’s where you understand the upside and true relationships with patients.

Romin: And at a minimum, every internist should have a strong nephrology foundation. It’s core to patient care.3

Final takeaways

What stood out from this conversation is how much of the future of nephrology sits outside the clinic, and how few early-career physicians get real exposure to it. The fellowship gives participants a window into the policy, economic, and organizational forces that shape how care is delivered, not just how it is practiced. For a field navigating reimbursement pressure and shifting care and payment models, that perspective is increasingly important. The clinicians who take the time to understand and engage with these dynamics will be better positioned to build sustainable practices, advocate effectively for their patients, and contribute to how the field evolves over time.

These same themes were on display at last year’s RPA Advocacy and Innovation Weekend, where conversations around policy, practice, and emerging technologies are increasingly overlapping. The AI Summit explored how these tools are beginning to influence clinical and operational decision-making, and I look forward to continuing that discussion in Atlanta later this week. If you’ll be there and want to connect, let me know.

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If you’re a nephrologist or practice leader attending RPA, we’re hosting a small dinner on 4/18 from 6–8pm ET with Confido Health to bring together ~20 peers to talk about what’s top of mind in growing and operating practices today. If you’d like to join us, please reach out below.

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Your curated list of high priority open roles across the kidneyverse, delivered straight to your inbox every two weeks. You can opt in or out anytime. Thanks for being here.

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At A Glance

• Principal Engineer, AI Products & Platform (Aledade)

• Manager, Reporting & Analytics (Evergreen Nephrology)

• Executive Director, Scientific Communications (Travere)

• Sr. Principal Engineer, Device Innovation (Edwards Lifesciences)

• Kidney Nurse Navigator (Conviva Senior Primary Care)

• Transplant Hepatologist (University of Rochester)

• Director, U.S. Market Access Marketing (AstraZeneca)

• Deputy Director, Nephrology (The Royal Melbourne Hospital)

• Business Coordinator, Intelligent Care (UC San Diego Health)

• Lead Analyst, Risk Adjustment Analytics (Strive Health)

• Senior Manager, Clinical Project Manager (Akebia)

• Senior Buyer (Diality)
  
  

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Open Roles

• UC San Diego Health is hiring a Business Coordinator, Intelligent Care (San Diego, CA, On-site) to support the CMO’s office and the West Health Accelerator, a partnership focused on advancing technology-enabled care for older adults. UC San Diego Health is one of the country’s leading academic health systems, and this role sits at the center of several high-priority strategic initiatives. The ideal candidate brings 7+ years of related experience in executive administration, project management, or business coordination, with strong analytical skills and the ability to manage competing priorities in a complex environment. Apply here!

• Aledade is hiring a Principal Engineer, AI Products & Platform (Remote) to shape the technical foundation of one of value-based care’s most recognized companies. Aledade partners with independent primary care practices across the country to help them succeed in value-based contracts, and is now building the next generation of AI-powered tools to support that mission at scale. This is a senior technical leadership role reporting to the SVP of Engineering, with scope to influence dozens of engineering teams and architect systems from the ground up. The ideal candidate brings 10+ years of production engineering experience, deep expertise in distributed systems, and a track record of technical decision-making at scale. Apply here!

• Evergreen Nephrology is hiring a Manager, Reporting & Analytics (Remote) to lead a small analytics team building the data infrastructure that drives clinical outcomes and business performance across their value-based nephrology practice. Evergreen is one of the fastest-growing kidney care companies in the country, partnering with nephrologists to deliver coordinated, value-based care to patients with chronic kidney disease. The ideal candidate brings 5+ years of experience in healthcare analytics, strong SQL skills, and hands-on experience with Power BI or Tableau. Python experience is a plus. This role reports to the VP of Analytics and comes with real room to grow. Apply here!

• Travere Therapeutics is hiring an Executive Director, Scientific Comms (San Diego, CA, Hybrid) to lead portfolio-wide scientific communications strategy as a senior member of the Global Medical Affairs leadership team. Travere is a biopharmaceutical company focused on rare kidney and liver diseases, with an approved therapy for IgA nephropathy and an active pipeline. This is a portfolio-level leadership role spanning publications, medical education, and congress strategy across multiple assets. The ideal candidate holds a PharmD, PhD, or MD and brings 12+ years of experience in scientific communications or medical affairs, ideally with rare disease or nephrology experience. Apply here!

• Edwards Lifesciences is hiring a Senior Principal Engineer, Device Innovation (Irvine, CA, On-site) to join a hand-picked incubation team tackling the hardest unsolved problems in structural heart disease. Edwards is one of the most respected names in cardiovascular medtech, known for its leadership in heart valve therapies and hemodynamic monitoring. This team is starting with a blank canvas and the mandate to potentially define an entirely new business vertical for the company. The ideal candidate brings a strong entrepreneurial background, cardiovascular medical device or diagnostics experience, and at least a decade of engineering experience. Apply here!

• Conviva Senior Primary Care is hiring a Kidney Nurse Navigator (Coconut Creek, FL, On-site) to support patients with chronic kidney disease, dialysis, and transplant care within a senior-focused primary care setting. Conviva is a CenterWell company and one of the largest senior primary care providers in the country, built around value-based care for Medicare patients. This is a care coordination role for an experienced RN who can guide patients through complex care pathways and collaborate across multidisciplinary teams. Nephrology nursing certification and experience in value-based care or population health are strongly preferred. Apply here!

• University of Rochester Medical Center is hiring a Transplant Hepatologist (Rochester, NY, On-site) to join a collaborative team of transplant surgeons and hepatologists managing end-stage liver disease across the full continuum of care. URMC is one of the leading academic medical centers in the Northeast, with a robust transplant program and strong ties to the University of Rochester School of Medicine and Dentistry. Candidates should be board-certified or board-eligible in Transplant Hepatology, eligible for New York State medical licensure, and at a level commensurate with appointment at the Associate Professor level. Apply here!

• AstraZeneca is hiring a Director, U.S. Market Access Marketing (Boston, MA, On-site) to lead payer and provider marketing strategy for Alexion's rare disease portfolio. Alexion, an AstraZeneca company, is the global leader in complement biology and rare disease therapeutics, with a portfolio that includes treatments relevant to kidney and hematologic disease. This role sits at the intersection of brand marketing, health economics, and access strategy, building campaigns across payers, specialty pharmacies, and channel partners. The ideal candidate brings 5-7 years of U.S. managed care or pharmaceutical marketing experience and a working knowledge of medical and pharmacy benefit reimbursement. Apply here!

• The Royal Melbourne Hospital is hiring a Deputy Director of Nephrology (Melbourne, Australia, On-site, Part-Time) in a senior clinical leadership appointment designed for a nephrologist who excels in operational strategy and systemic improvement. The Royal Melbourne is one of Australia's premier academic health systems, with a renal service that spans inpatient, outpatient, and community-based care. This role balances administrative and governance responsibilities with dedicated clinical commitments. Candidates must hold FRACP (Nephrology), a PhD, and be registered or eligible for registration with the Medical Board of Australia. Apply here!

• Strive Health is hiring a Lead Analyst, Risk Adjustment Analytics (Denver, CO, On-site) to drive financial performance and clinical strategy across one of the most prominent kidney care companies in the value-based care space. Strive partners with health plans and health systems to manage high-risk kidney disease patients in value-based arrangements, and this role sits at the core of how they evaluate and optimize that performance. The ideal candidate brings 4+ years of risk adjustment analytics experience, deep familiarity with MMR, MOR, and MAO-004 data, strong SQL and Excel skills, and at least 3 actuarial exams passed. Apply here!

• Akebia Therapeutics is hiring a Senior Manager, Clinical Project Manager (Cambridge, MA, On-site) to oversee the full lifecycle of clinical trials at a nephrology-focused biotech with an approved therapy for anemia in chronic kidney disease. Akebia is one of the few companies with deep, dedicated focus on the biology of kidney-related anemia, and this role is central to how they advance their pipeline. The ideal candidate brings 5+ years of clinical research operations experience, including at least 3 years managing Phase 1-4 studies directly, with a strong track record of running trials in-house with limited CRO support. Apply here!

• Diality is hiring a Senior Buyer (Irvine, CA, On-site) to optimize procurement and supply chain operations for a medical device company developing a portable home hemodialysis machine. Diality is building technology designed to give kidney disease patients more freedom and flexibility in how they manage dialysis, and this role supports the operational backbone of that mission. The ideal candidate brings 5-8 years of supply chain experience in an FDA-regulated medical device environment, with strengths in supplier relationship management, new product introduction, and life cycle management. CPIM or CPM certification and Six Sigma experience are a plus. Apply here!

Every one of these roles is a chance to move the needle on kidney health. We hope you find yours. More roles added weekly at jobs.signalsfs.com.

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Every four minutes, someone in the United States reaches kidney failure. That is more than 130,000 people each year crossing into the most advanced and costly stage of disease. Most never get there. They die first, most often from cardiovascular complications, before the system ever registers them as a kidney patient.1

Thirty-seven million Americans have chronic kidney disease, and ninety percent do not know it. The United States spends more than $150 billion per year managing the consequences and over $50 billion on dialysis alone.2 Against that, the NIH invests just $19 per patient annually in understanding how to treat and prevent it.3 The system is not ignoring kidney disease, it is paying for it at the worst possible moment.

Kidney disease is one of the most common, expensive, and invisible chronic conditions in modern medicine. It sits in plain sight, shaping outcomes across cardiovascular disease, diabetes, and metabolic health, yet remains largely undiagnosed until its latest stages. This is not a niche problem confined to nephrology. If you develop drugs for cardiometabolic disease, manage risk in a payer organization, operate a primary care network, or build diagnostics and data infrastructure, you are already positioned at the center of one of healthcare's most significant market shifts in decades. The only question is whether you are seeing it clearly enough to act on it.

The Signal Nobody’s Reading

Two simple and widely available tests, eGFR from a blood draw and albuminuria from a urine sample, can detect kidney damage years before symptoms appear. These markers often signal risk earlier than cholesterol, blood sugar, or body mass index, capturing decline before it becomes visible in more familiar ways.4 In that sense, kidney function does not just track disease, it anticipates it.

Figure: The kidney sits at the center of the cardiometabolic system

Heart disease, metabolic disease, and kidney disease are deeply interconnected. They share biology and reinforce each other over time. Kidney function is often where that shared decline surfaces first, making it one of the clearest indicators of where a patient is heading.5

Miners carried canaries because they needed a signal sensitive enough to detect danger before humans could. The kidney serves a similar role in medicine today, offering an early warning that something in the broader cardiometabolic system is beginning to fail. The difference is that we have built a system that consistently ignores the warning.

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A System Designed Around the Wrong Endpoint

The reason this signal goes unaddressed is not scientific, it is structural. In 1972, Congress established a Medicare entitlement for end-stage renal disease, making it the only conditions in U.S. history to receive guaranteed coverage regardless of age.6 The decision was grounded in compassion for patients facing certain death, and it fundamentally reshaped the economics of kidney care for the next fifty years.

When payment is guaranteed at the point of failure, the system organizes around that endpoint. Dialysis infrastructure expanded rapidly. Clinical training focused on late-stage disease. Research investment followed areas with clear reimbursement pathways. Over time, the system became highly effective at sustaining life once kidney failure occurs, but far less capable of preventing patients from reaching that point in the first place. For patients, this means the first time they hear ‘kidney disease’ is often when there’s only one option in front of them.

Figure: A 50-fold increase in dialysis patients since the Medicare ESRD entitlement

The dialysis chair is a life-saving intervention for more than 550,000 Americans. It is also the endpoint toward which decades of incentives have been aligned. Outcomes on dialysis remain sobering, five-year mortality exceeds 50%, worse than many common cancers, yet the system continues to optimize around it. The same incentive structure that built the dialysis industry has made it difficult to expand alternatives. While nine in ten nephrologists report they would choose home dialysis for themselves, fewer than 15% of patients receive dialysis at home.7 Annual kidney transplants reach only a fraction of those who need them.8

This dynamic was reinforced by specialization. Nephrology, cardiology, and endocrinology evolved in parallel, often managing the same patients through disconnected care models. No single part of the system owned the full trajectory of risk. Earlier stages of disease, where intervention could slow or prevent progression, received far less attention.

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Science, Data, & Policy

The science has advanced in a meaningful way. Therapies now exist that can slow kidney disease progression, which means finding patients earlier is no longer just a diagnostic exercise, it is an actionable one. SGLT2 inhibitors and GLP-1 receptor agonists have demonstrated consistent benefits across both cardiovascular and kidney outcomes. At the same time, new therapies targeting conditions such as IgA nephropathy and APOL1-mediated disease are establishing new paths for precision medicine in nephrology. Kidney endpoints are becoming central to how therapies are developed, evaluated, and commercialized.910

The data environment is shifting, but not in the way the technology optimists usually describe it. The bottleneck was never the absence of data. Across the operators, payers, diagnostic companies, and policymakers we have spoken with over the past year, the same problem surfaces in different language: the signal exists, can be detected, and is routinely generated by tests that cost less than a co-pay. What doesn’t exist is the infrastructure to keep that signal alive as a patient moves through the healthcare system. A risk flag created under one employer’s insurance plan disappears when that patient changes jobs. A lab result sits in one system while the treating physician works in another. A kidney decline visible in the data years before a crisis arrives triggers no intervention because no one in the care chain is accountable for connecting the signal to a response. This is fragmentation, and it is not a technology problem. It is a coordination and incentive problem, which means solving it requires more than better software. It requires someone to own the patient’s trajectory across the gaps the current system leaves open.

Policy is the most powerful lever in this system, and the hardest one to move quickly. The people working on it are not the problem. The structure is. Payment model design runs on multi-year cycles by necessity: build a model, run it, wait for the data, analyze it, and iterate. The Kidney Care Choices model, the federal government’s most ambitious experiment in rewarding earlier kidney intervention, just reported that participating care entities generated $311 million in gross savings in its most recent performance year. That is a real signal, produced by real operators doing real work. But that result took years to generate, and the model itself sunsets in 2027. Meanwhile, leadership priorities shift every four years. What the field actually needs, and what we do not yet have, is a policy infrastructure capable of learning and adjusting in closer to real time: one that treats early intervention as a reimbursable act rather than an act of goodwill.

The Canary for the System

Kidney disease is not just a clinical problem. It is a diagnostic for how the healthcare system behaves. It reveals how early signals can be present and measurable, yet fail to drive action. It shows how payment structures shape behavior more consistently than clinical evidence. It highlights how preventable progression becomes normalized when incentives are misaligned.

These dynamics extend far beyond kidney care. They are simply easier to observe here because the signal appears earlier and the consequences are well defined. If these patterns can be addressed in kidney disease, they can be addressed elsewhere. If not, they will continue to repeat across other chronic conditions.

Figure: Cardiovascular costs are projected to reach $1.4 trillion by 205011

Kidney disease rarely appears in isolation. It sits at the center of cardiovascular disease, diabetes, and metabolic health, conditions that together represent some of the largest and fastest-growing cost categories in American medicine. That is precisely why kidney disease remains undercounted and underprioritized. The costs are visible, but they are attributed elsewhere. The signal is present, but no single part of the system owns it.

This is where the canary analogy earns its weight. The kidney is not just another downstream consequence of diabetes and hypertension. It is the earliest measurable indicator that those conditions are winning. Finding and managing kidney disease earlier does not just change the kidney trajectory. It changes the cardiovascular trajectory, the metabolic trajectory, and ultimately the cost trajectory for the entire system. The burden of these conditions is already large and growing fast, with direct costs projected to reach $1.4 trillion by 2050. If we want to bend that curve, we should be looking more closely at the kidneys. That is where the earliest signals emerge, where disease pathways converge, and where the opportunity to intervene still exists.

Why This Moment Matters

The United States spends more than five trillion dollars annually on healthcare, yet outcomes across chronic disease continue to lag behind peer nations.12 This gap is not due to a lack of scientific capability or clinical expertise. It reflects a system built to respond to late-stage illness rather than act on early signals.

Figure: Treating kidney disease at the wrong stage costs ten times more

The cost curve is not an abstraction. A patient identified at Stage 2 costs the system roughly $15,000 per year. The same patient at end-stage kidney disease costs nearly eight times that, driven by dialysis and hospitalizations that earlier intervention could have prevented. The system is not failing to spend money on kidney disease. It is spending it at precisely the wrong moments. In 2024, the NIH invested just one half of one percent of what Medicare spends managing the disease each year. The payment system rewards the crisis, not the prevention.

The Value Capture Problem

The economics of kidney care have never been broken, they have been working exactly as designed. A system built around guaranteed payment at the point of failure created a fifty-year business model for managing end-stage disease. What it has not done is create returns for the organizations willing to invest upstream, where the actual prevention happens.

That dislocation is what this series is about. Value is being created across the cardio-kidney-metabolic (CKM) continuum by drug developers, diagnostics companies, data platforms, and care delivery innovators doing the hard work of finding patients earlier, getting them on the right therapies, and keeping them out of the most expensive and least effective stages of disease. But the financial architecture still routes disproportionate returns toward late-stage intervention.

The science has moved. The payment models are beginning to move. The data infrastructure is being built. What has not moved fast enough is capital; specifically, the capital willing to fund companies working upstream, before the crisis, in the spaces the current reimbursement system does not yet adequately reward. The window between when the science is proven and when the payment system fully catches up is where the best returns in health innovation have historically been built. That window is open right now in kidney and CKM care, but it will not stay open indefinitely. The question is who will be positioned to lead it when it does.

In Part Two, we map where the gaps are largest and where a new generation of companies is beginning to close them.

We want to hear from you. If you are building, investing, or working in kidney or cardiometabolic care, leave a comment below.

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What Happened in PY24

PY24 was supposed to be the KCC Model at full stride. Both cohorts were operational, the provider network had grown to over 9,200 participants, and aligned beneficiaries reached 282,335, the largest patient panel the model had covered to date. The full incentive structure was in place: the CKD Quarterly Capitation Payment, the $15,000 Kidney Transplant Bonus, and shared savings available across all risk tracks.

Figure: KCC model participation and beneficiary alignment, PY22–PY26

Then, after the May termination date, twenty entities exited based on participant lists provided by CMS in subsequent years.1 Effective participation dropped to 103 KCEs and 186,948 aligned beneficiaries. What makes this significant is the timing: it happened before CMS announced any changes to the model’s incentive structure. Whatever drove that decision, it was a judgment about the economics of the program and selected risk tracks for those participants.

What makes PY24 worth examining closely is that we now have entity-level reconciliation data for it. Combined with comparable PY22 data, we have a before-and-after picture of 116 unique entities operating under the model’s original financial architecture. Signals assembled this dataset from publicly available CMS reconciliation files. It is the most granular look we will have at how the model performed when fully funded and incented, and we think it warrants synthesis, analysis, and discussion.

Reading between the lines

The headline most people know is that the KCC Model cost Medicare roughly $304 million in net losses in PY23. That number is important, but it’s only part of the larger story, as I've shared before. The breakdown of where that $304.8M actually went tells a different story than the headline suggests. When you look beneath it at what individual entities actually did: how they performed against their benchmarks, how quality scores moved, how the cohorts compared, the picture is far more complete and compelling.

Table: How Medicare calculates net KCC spend (PY23)

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Let’s start with the math behind that $304M figure. The Lewin Group’s PY23 evaluation showed that more than 60% of that loss came from the incentive payments themselves - that’s the QCP, shared savings distributions, transplant bonuses, and high performers pool. These weren’t wasteful spending, they were what CMS deliberately designed to change behavior, and they did. The gross Part A&B claims impact was $115.6M. Significant, yes, but a different story than the net headline. Most of the “losses” in the headline number were planned incentives from CMS, not overspending by providers. In other words, CMS paid providers to change behavior, and those payments show up as “losses” in the program-level accounting.

The chart below shows how those components stack up across PY22, PY23, and PY24. In PY23, the hatched green bar drops below zero, that is the claims impact, not a savings figure. In PY22 and PY24, the solid green bars represent gross savings generated by entities against their benchmarks.

Figure: KCC model financial performance, PY22–PY24

The PY24 reconciliation data adds another layer. The 80 KCEs active in PY24 generated $311 million in gross savings against their risk-adjusted benchmarks, nearly five times the $63 million generated by 55 KCEs in PY22, and a ~3x jump in gross savings rate from 1.2% to 3.6% of benchmark. That trajectory matters, and it may be one of the clearest signals this model is working as intended.2

At the entity level, 67 of 80 KCEs generated positive net savings in PY24. That’s 84% of the shared-risk entities in the model, at a mean savings rate of 1.9% of benchmark. The Cohort 1 entities, two full years in, averaged 2.0% with 40 of 45 in positive territory. The Cohort 2 entities, in just their second year, averaged 1.8% with 27 of 35 positive. A gap of less than a quarter point between experienced and newer participants is not a steep learning curve. It suggests the model's financial logic is fairly accessible once the infrastructure is in place.

Performance varied by affiliated organization in ways that are worth examining closely, both for what improved and for what the patterns might suggest about different approaches to building sustainable kidney VBC infrastructure. Here is where things stood for Cohort 1 entities with data in both years:

Table: Top 10 Entities by Gross Savings ($) and Net Savings (%)

A few observations stand out. Interwell entered PY24 with the strongest quality scores and held them. DaVita showed meaningful improvement on both quality and savings. DCI improved substantially on quality scores across all three of its entities, with one achieving a perfect score by PY24 and earning recognition in the high performers pool. US Renal Care had the highest net savings rate in PY24, a trajectory of improvement that raises good questions about what changed operationally and what others can learn from it. In my view, these are the kinds of patterns worth tracking as PY25 data eventually becomes available. Behind these numbers are hard won lessons from delivering care locally.

Among top performers clearing 3.6% of benchmark in PY24, DaVita accounted for four entries, with Evergreen and US Renal Care each contributing two. On quality, Interwell led with five entities scoring in the top decile. The two measures don’t always travel together, and that gap is worth watching as the field matures. One exception is worth calling out. The green-highlighted entity appearing in both tables operates across Iowa, Kansas, and Nebraska. With roughly 2,000 aligned beneficiaries, a quality score of 85%, $10 million in gross savings, and a net savings rate of 4.4% of benchmark, it was among the model's top performers on both dimensions in PY24. And it did so in its second year of participation.

Taken together, these patterns suggest there isn’t a single path to success in kidney VBC. Some organizations are winning through care infrastructure and consistency. Others are improving through their scale and iteration cycles. And a few appear to be unlocking step-changes in performance that aren’t yet fully understood. As more data becomes available, the key question won’t just be who performed best, but which of these approaches proves most durable under changing incentives.

One thing worth dwelling on before we move to the policy picture: kidney care VBC is uniquely challenging compared to many other risk-bearing models, especially those further upstream where patient panels are large and risk tends to average out. These specialty ACO entities are managing populations defined by advanced, multimorbid disease. A single patient progressing from CKD Stage 5 to ESRD mid-year, or a cluster of high-cost hospitalizations in one quarter, can move a small entity’s financials materially. Risk adjustment helps, but those swings matter for KCEs and the patients they serve. Comparing a 500-beneficiary independent practice in rural Mississippi to a 3,000-beneficiary entity in metropolitan Texas on a single savings percentage misses most of what is actually happening. I’m consistently impressed by what these practices are doing on the ground: managing extraordinarily complex patients in a new payment paradigm while still generating measurable savings. That context is important to keep in mind when reading these numbers.

We need to talk about hospitalizations

There is one metric worth addressing honestly: hospitalizations. Reducing those costs is a central quality mandate of the model, and it is a downstream outcome that would most clearly validate the long-term investment thesis, alongside reducing total cost of care and increasing optimal starts.3 We don’t have claims data here. What we do have is the Lewin Group’s PY23 evaluation, which found no statistically significant impact on hospitalizations, readmissions, or emergency department visits.

That finding deserves context rather than alarm. The clinical investments the model drove upstream are exactly the kind of interventions that should reduce acute care events over time.4 We saw a 31% increase in optimal ESRD starts, 10% more home dialysis use, a 69% jump in preemptive transplants, and 29% fewer hemodialysis catheters. Each of these is significant on its own, and together they’re a strong positive signal. The PY24 financial data suggests those investments are beginning to translate into measurable cost management, even before seeing hospitalization trends. The open question is whether reducing the QCP and eliminating the transplant bonus will slow the clinical progress that was supposed to produce those reductions in the first place. You cannot cut the upstream investment and expect the downstream savings to show up on schedule, if at all.

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Why this timing matters

In May 2025, CMS announced a set of changes to the KCC Model effective in 2026. These included a 50% cut to the CKD QCP and elimination of the Kidney Transplant Bonus. Benchmark discounts of 1% were added for both the Professional and Global tracks. The KCF option was terminated a year early. The CKCC options were extended through 2027, but under this restructured design. Everything is a balancing act: CMS needs to experiment with model incentives to find sustainable ways to drive down costs, while model participants need incentives to finance and scale care models that deliver better outcomes. That is why the CMS innovation center exists, and it’s also why more than $2 billion in private capital has flowed into value-based kidney care models in recent years.

PY24 and PY25 were the last two years in which the model operated under its original incentive architecture. Since PY25 entity data is not yet public, PY24 is the last complete picture we have of what the model looked like when fully funded under this incentive design structure. The participation trajectory makes this sharper: from 130 entities at peak in PY23 to 74 in PY26, a 43% decline over three years, all happening while clinical outcomes were improving. The entities that remain built infrastructure and scale needed to continue growing. With over 1.5 million lives and nearly $40 billion in medical spend under management, the kidney VBC entities have grown well beyond the ~237,000 beneficiaries currently aligned to the KCC model. The question most operators are sitting with now is this: how do we plan for what comes next, and how do we sustain what we've built until we know?

What we’re watching now

July 2026 marks roughly 18 months from the model’s current end date. That is historically the window in which CMS signals what comes next, whether that means a successor model, a certification pathway, or a sunset.

Figure: KCC incentive payment components, PY22–PY245

Here is what we will be watching:

1. What will a full PY24 evaluation show? The reconciliation data tells us what entities recorded. A Lewin-style evaluation would tell us what the model actually caused, including whether hospitalizations finally moved and whether the savings are there. That distinction matters enormously for what CMS decides to do next.

2. Can entities sustain care coordination infrastructure under reduced incentives? The QCP funded the coordinators, navigators, and modality educators that drove quality gains. A 50% cut is steep, so time will tell whether clinical progress holds or erodes.

3. What happens to transplant access in future innovation center models? The KTB is gone and the IOTA model shifts focus to transplant hospitals rather than the nephrologists who identify and navigate transplant-eligible patients. It’s hard to run a controlled experiment in the “real” world, so keep an eye on both models.

4. How does MA growth change the calculus? Several organizations in KCC are running parallel MA-based kidney care strategies. For many, it’s their primary growth strategy. While federal APMs set the tone for private payer alignment, MA operates under different constraints. How organizations navigate those tradeoffs while chasing what remains a large pool of unmanaged spend will be worth watching.

5. What does consolidation look like from here? The model has an end date. Capital raised by kidney VBC organizations over the past several years is maturing, investment timelines are tightening, and the public markets are watching what companies like Omada, Hinge, and Virta demonstrate about the tech-enabled path to scale and profitability.6 I’d wager the dozen or so organizations operating in this space will look a bit different in 18 to 24 months.

Final thoughts

We are still working through the details, and a full PY24 evaluation will add important context if and when it arrives. We don’t yet know whether CMS plans a KCC 2.0, a certification pathway, or something else entirely. We expect the second half of this year to tell us a great deal. In the meantime, PY24 is the most complete picture available of what this model produced under the conditions it was designed for.

Based on the information we have, PY24 suggests the model can work. The question now is whether the system has what it needs to continue funding the next generation of accountable care.

We’d like to hear what you’re seeing. If you’re operating in this model, what are we getting right, what are we missing, and what should others know as they interpret these results?

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Signals Advisory built a full entity-level year-over-year tracker covering PY22 and PY24 KCC reconciliation data: 116 unique entities, 35 metrics, and the financial and quality trends underlying the findings in this brief. It is part of our broader value-based kidney care research offering, which tracks more than 1.5 million lives and nearly $40 billion in medical spend under management across the kidney VBC landscape. Available to operators, startups, industry, investors, and those looking to go deeper on these topics.

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By popular demand, we're bringing a curated list of high priority open roles to your inbox every two weeks. The range of companies and positions reflects the full breadth of this ecosystem, from the lab to the bedside, and everyone building in between. You can opt in or out anytime. Thanks for being part of Signals.

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At A Glance

• Sr. Laboratory Auditor, Quality Assurance GLP (Travere)

• Associate Director, Tax Operations (Natera)

• Program Manager (Vantive)

• Advanced Account Manager (Mozarc Medical)

• Associate Director, Environmental Health & Safety (ProKidney)

• National Business Director, Thymoglobulin West (Sanofi)

• Sales and Account Representative (RenalEdge GPO)

• AI Innovator in Residence (PRINE Health)

• Clinical Registry Research Coordinator (GlomCon Foundation)
  
  

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Open Roles

• Travere is hiring a Sr. Laboratory Auditor, Quality Assurance GLP (remote, San Diego) to lead execution of GLP quality audits and support the integrity of data generated across preclinical and clinical development programs. The ideal candidate brings 6+ years in drug or biologics development, at least 5 years of GLP/QA experience, and deep knowledge of global regulatory frameworks including FDA, EMA, and OECD guidelines. Travere is a rare disease biotech with a focused kidney and metabolic disease portfolio. Apply here!

• Natera is hiring an Associate Director, Tax Operations (remote) to lead multi-state tax strategy, governance, and execution for a publicly traded genomics company. The ideal candidate brings 10–15+ years of experience in state and local taxation, payroll tax, and equity compensation, with a background in Big 4 or large multinational environments and hands-on SOX compliance experience. Natera is a leading genetic testing and diagnostics company with a significant and growing presence in kidney health through its Renasight gene panel and Prospera transplant monitoring portfolio. Apply here!

• PRINE Health is hiring an AI Innovator in Residence (hybrid, New York) to own and execute their AI and digital transformation strategy, building and deploying solutions across clinical operations, revenue cycle, and patient workflows. The ideal candidate is early to mid-career with a CS, data science, or health informatics background, someone who has shipped real things in production and moves fast without waiting for permission. PRINE Health is a physician-owned and led nephrology supergroup that has expanded into a unique independent multispecialty network spanning primary care, care management, and a range of specialties, all built around a value-based kidney care model. Simon Prince, PRINE’s founder, wrote a great piece for us last year on what makes their model different. It’s worth a read if you want to understand the vision behind this role. Apply here!

• Sanofi is hiring a National Business Director, Thymoglobulin West (remote) to serve as the medical policy and product expert across kidney transplant centers, health systems, and IDNs, driving access and adoption of Thymoglobulin in the transplant setting. The ideal candidate brings 6+ years of field-based pharma or biotech experience with a background in solid organ transplant, payer strategy, and health system engagement. Thymoglobulin is a cornerstone immunosuppressive therapy used in kidney transplantation, and this is a high-visibility commercial role on a team we know well. Adam and Todd are building something special here. Reach out if you think you’re a fit and want an intro. Apply here!

• Vantive is hiring a Program Manager (onsite, Plymouth MN) to lead project execution across product development initiatives, owning timelines, budgets, and cross-functional coordination from identification through implementation. The ideal candidate brings 10+ years of product lifecycle experience, 5+ years of project management in medical devices, and PMP certification. Vantive is a kidney-focused medical device company spun out of Baxter last year, specializing in peritoneal dialysis, hemodialysis, and acute renal therapies. Apply here!

• Mozarc Medical is hiring an Advanced Account Manager (hybrid, San Francisco) to drive sales growth across a vascular and dialysis access portfolio, building relationships with interventional radiologists, nephrologists, and vascular surgeons. The ideal candidate brings 4+ years of B2B or healthcare sales experience and a background in medical devices. Mozarc Medical is a kidney-focused med tech company formed from equal investments by DaVita and Medtronic, focused on reimagining holistic kidney health technology. Apply here!

• ProKidney is hiring an Associate Director, Environmental Health & Safety (onsite, Winston-Salem NC) to lead EHS programs across all company sites, ensuring regulatory compliance and a culture of safety across manufacturing, quality, and laboratory operations. The ideal candidate brings 7–10+ years of EHS experience in biotech or pharma manufacturing, with a background in GMP environments and multi-site operations. ProKidney is a clinical-stage biotechnology company developing an autologous cell therapy designed to slow the progression of chronic kidney disease. Apply here!

• RenalEdge GPO is hiring a Sales and Account Representative (remote) to educate members on GPO partnerships and drive engagement across a growing renal-focused group purchasing organization. The ideal candidate brings 5+ years of medical sales experience, with GPO and renal sales experience strongly preferred. RenalEdge serves independent dialysis providers and health system members, helping them access better pricing and services across the renal care supply chain. Reach out if you think you're a fit and want an intro, who wouldn’t want to work with Glenn Davis?! Apply here!

• GlomCon Foundation is hiring a Clinical Registry Research Coordinator (remote) to support the day-to-day operations of a global clinical data registry and real-world evidence studies focused on rare kidney disease. The ideal candidate brings 2–4 years of clinical research coordination experience, with a background in registry-based or observational studies preferred. GlomCon is a global nephrology education and research platform dedicated to advancing the understanding and treatment of glomerular diseases. Apply here!

Every one of these roles is a chance to move the needle on kidney health. We hope you find yours. More roles added weekly at jobs.signalsfs.com.

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Are you hiring? Post a role on Signals Jobs. Looking for your next opportunity? Browse the full board. We believe great talent is everywhere, and that the right people in the right roles get us closer to a world without kidney disease.

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In this conversation, we discuss the stagnant state of transplant therapeutics, what patients still face after transplant, the promise of surrogate endpoints like iBox, and why stronger alignment across patients, clinicians, industry, and regulators could help unlock a new era of innovation.

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This is the first in a series of conversations exploring the transplant therapeutics landscape and what it will take to unlock a new era of innovation in the field.

Q&A

Let’s start with introductions. What is your background and connection to this space?

BF: I spent most of my career in the pharmaceutical industry, focused on drug development and regulatory affairs. I started working on the development of tacrolimus for transplant immunosuppression in 1990. Since retiring from industry, I’ve been active on the executive committee of the Transplant Therapeutics Consortium, a public-private partnership working to advance tools and processes that can help bring more innovation into transplantation.

KF: I spent more than 25 years in the pharmaceutical industry, and Bill and I crossed paths during our time at Astellas. In 2014, I started my own consulting business, where I work with pharma companies on earlier intervention in kidney disease and better treatments in transplant. I’ve also been living with a kidney transplant since August 2004, so this is both professional and deeply personal for me.

Bill, how do you see the current state of transplant therapeutics and innovation?

BF: Unfortunately, innovation in transplant therapeutics has been fairly stagnant. There are drugs in development, but very few have made it across the goal line and into clinical use. The last novel immunosuppressant approved by the FDA was in 2011. So we have gone roughly 15 years without a truly new immunosuppressant reaching the field.

Figure: FDA Drug Approvals by Year and Therapy Area, 2000-22

Our current standard of care, tacrolimus in combination with mycophenolate mofetil, has been around for more than 30 years and is still used in 80% to 90% of new transplants globally.1 So while there has been scientific activity, there has not been much innovation that has actually reached patients over the last decade, or really the last three decades.

Kidney more broadly has seen progress in recent years. Why has transplant lagged behind?

BF: One of the main reasons is that the current regimen performs well in the short term. We have low acute rejection rates and strong patient and graft survival at one year. That creates a high bar for showing superiority over standard of care in a traditional trial design.

But the long-term picture is still not where it needs to be. Kidney graft survival at 10 years is only about 50% to 60%, and patients still carry a heavy burden from side effects and tolerability issues related to chronic immunosuppression.2

Compare that with IgA nephropathy. In 2017, there were no approved therapies for IgAN. But through close engagement among FDA, sponsors, researchers, and patients, a more workable development pathway emerged, including the use of proteinuria as a surrogate endpoint for accelerated approval. That changed the field. Since 2021, five new drugs have been approved for IgAN, and several more are in late-stage development. It is a strong example of how regulatory partnership can unlock investment and therapeutic development in kidney disease.3

Figure: Landscape of IgAN clinical trials over the last 3 decades (2022)4

So the challenge is not just scientific or clinical. It is also regulatory?

BF: Exactly. The short-term outcomes are good enough that the field has been stuck. That is a good problem in one sense, but it also becomes a barrier if it keeps us from improving long-term outcomes and quality of life.

There is a real opportunity for transplant to follow a model similar to what happened in IgAN and other areas like HIV, oncology, and liver disease. Those fields benefited when regulators and stakeholders aligned around tools that made development more feasible. Transplant has not yet been able to do that in the same way.

Kevin, where do you see the patient voice in this landscape today?

KF: There has been progress, and I think it is important to acknowledge that. CMS is now working on a patient-reported outcome measure, which is a big step. The American Society of Transplant Surgeons has also launched a patient voice initiative to better educate and engage patients on legislative issues and public policy.

That said, I still think there is a major opportunity to more directly engage the patient community with the FDA around the issues Bill is describing. I served on the Kidney Health Initiative for more than a decade and saw firsthand what can happen when patients, clinicians, industry, and regulators are all at the table together.

I would love to see a listening session between the FDA and the transplant patient community this year so we can have an honest conversation about what life after transplant is really like and what patients still need.

What are some of the biggest misconceptions about life after transplant?

KF: One of the biggest misconceptions is that transplant is a cure. It is not. As Bill said, long-term outcomes remain a major problem. If 50% to 60% of grafts fail within 10 years, that is not a cure.

The other issue is quality of life. Even for people doing relatively well, transplant can still come with a heavy treatment burden. My experience is not the norm.

There is also something I have written about called the “gratitude paradox.” Many transplant recipients are understandably grateful to be alive and to have received an organ. I feel that too. But that gratitude can sometimes make it harder to speak openly about ongoing burdens, side effects, fear of loss, and the reality that life after transplant is still medically complex.

And the broader public often does not understand the full picture. A recent Office of Inspector General report showed how hard it is even to get onto the waitlist, let alone get transplanted.5 If you are one of the few who makes it through years of dialysis and then receives a kidney, you may not feel like complaining, even if the system still has major shortcomings.

March 2026 OIG Report

Bill, what are some of the realities patients face after transplant that the field still has not solved?

BF: One major issue is that we still do not have enough tools to individualize treatment. Most patients get essentially the same drugs, but not everyone will tolerate the same regimen equally well.

Current immunosuppressive regimens bring significant toxicities. New-onset diabetes after transplant, for example, occurs in more than 30% of recipients on current regimens.6 These are not minor side effects. They affect both quality of life and long-term graft and patient outcomes.

That is why we have focused so much on finding better tools. We need ways to predict what will happen long term without waiting five or ten years to find out.

Have there been real developments on that front?

BF: Yes. That is where the concept of a surrogate endpoint comes in. The goal is to measure something at one year post-transplant that is both prognostic and predictive of what will happen to the graft over five years and beyond.

That is what iBox is designed to do. It combines commonly measured lab tests for kidney function, immunologic response to the graft, and biopsy histology into a single score. That score can then help predict long-term graft function and survival. In practical terms, it gives you a number at one year that tells you a great deal about what is likely to happen over time.

KF: I would add that surrogate endpoints were not universally embraced in nephrology when these conversations started. I was part of National Kidney Foundation discussions on this back in 2018. But many of us came to support their use because we felt the potential upside for patients and innovation was worth it. The process was transparent, and patients had a chance to be part of that discussion.

What would broader use of iBox make possible?

KF: From the patient side, the biggest thing it provides is hope. I lose friends every year to premature graft loss. So when I think back to those early discussions about surrogate endpoints, what stayed with me was the possibility that things could actually change.

A clear regulatory pathway matters because companies need confidence before they invest. If there is a real pathway, more companies are going to take transplant seriously. That is what patients need. The unmet need is there.

BF: From the development side, iBox could help companies show superiority over current standard of care using an earlier, validated endpoint. That would make it possible to use expedited FDA pathways, including Accelerated Approval.7

There are innovative immunosuppressants out there, but many have been developed for autoimmune diseases rather than for transplant. We want to make it easier for companies and investors to bring those therapies into transplantation. If they can see a feasible path, that changes the equation.

Walk us through the development and qualification process for iBox.

BF: The original iBox model was developed by the Paris Transplant Group as a prognostic tool for individual patients, and it was published in 2019. They used data from roughly 4,000 kidney transplant recipients to build the model.

Through the Transplant Therapeutics Consortium, we took that patient-level prognostic model and adapted it into a trial endpoint. Then we brought it into the regulatory qualification process.8

Figure: iBox Regulatory Timeline with FDA and EMA (2023)9

With the European Medicines Agency, that process moved relatively quickly. iBox was qualified through the EMA in 2022, so it can already be used in kidney transplant development in Europe.10

With the FDA, we made our first submission in 2019 and are still in the process. There are three major steps in the qualification pathway, and we are now in the third. A big part of the work has been validation. We had to show that what was seen in the Paris dataset could also be replicated in other settings, including single-center datasets like Mayo Clinic and Helsinki, and randomized trials such as BENEFIT and BENEFIT-EXT. The answer has been yes, and that body of validation is central to what we submitted.

KF: I attended the 2018 FDA meeting where Alexandre Loupy presented the iBox concept, and I came away feeling hopeful that there was finally a path forward. It has been a long process. From my perspective as an advocate, one challenge is that the process has not always felt very clear from the outside. That is a contrast with some of the nephrology work, where patient participation in the discussion felt more visible.

What are the possible outcomes of the FDA’s current review?

BF: The best-case outcome is that iBox is qualified by the FDA as a reasonably likely surrogate endpoint that can be used in the Accelerated Approval pathway. That is the goal.

The FDA could also reject it outright and decide not to qualify it at all. Or they could say it is acceptable as a secondary endpoint, but not as a surrogate endpoint for accelerated approval.

Figure: Regular vs. Accelerated FDA Approval

Why would a secondary endpoint designation fall short?

BF: Because it would not accomplish what the field really needs. It would not create an expedited pathway, and it would not give companies the ability to promote superiority in the way that a validated surrogate endpoint could.

It would be better than nothing, of course. But it would not send the signal we need. What we are really trying to establish is that the FDA is partnering with the field to help jumpstart innovation in transplant. A secondary endpoint does not do that.

Kevin, where do you see the unmet need most clearly?

KF: It is everywhere. There is unmet need in BK virus, in antibody-mediated rejection (AMR), in highly sensitized patients still waiting on dialysis, and across the broader challenge of chronic nephrotoxicity from current standard of care.11

The fact that standard of care has barely changed in 30 years should tell us something. I struggle to think of another field where that would be considered acceptable.

And again, this is personal. I have had friends lose kidneys prematurely because of the toxicities of current treatment. Then they go back to dialysis and hope they survive long enough to get another transplant. That is real human suffering. We need better tools for physicians and better options for patients.

What should the transplant community be watching over the next few months?

BF: The FDA decision is obviously central. But just as important will be how the community responds to that decision.

If iBox is accepted as a reasonably likely surrogate endpoint, that would be a sign that the FDA is willing to partner with the community to move the field forward. Then the question becomes what happens next over the next five to ten years as companies, investors, and researchers respond.

If the decision falls short, then the community has to decide whether it is willing to accept the status quo. I do not think we should be. Transplant carries a unique moral obligation because every functioning graft represents a donated organ, whether from a living or deceased donor. We owe it to donors and recipients to do everything we can to preserve those gifts and improve long-term outcomes.

KF: What has happened in nephrology over the last decade has been remarkable. I honestly never thought I would see this level of change in my lifetime. That is why this moment matters.

However this turns out, I will not be quiet. If the outcome is positive, I will be celebrating it loudly. If it is not what the community hopes for, I will have a lot of questions. That is how I approach this. I keep coming back to the friends I have lost. That is what drives me.

Is there still an opportunity for people to speak up before a decision is made?

BF: From the TTC side, we are continuing to engage decision-makers at the FDA. We want to make sure there is awareness of the issue at every level of the organization. Beyond that, this is something patients and stakeholders can raise with their representatives. If this matters to them, they should say so. That is how public priorities are communicated through government.

Find Your Legislators

Any final thoughts to leave people with?

BF: Kidney transplant patients deserve safer, newer, better therapies, just like patients in any other serious and life-threatening condition. In fact, I would argue the obligation is even greater here because these therapies are meant to protect a donated organ. We are not asking anyone to lower the bar for safety or efficacy. We are asking the field to raise the bar for long-term outcomes.

KF: Success depends on partnership. Patients, industry, physicians, and the FDA all need to be working in the same direction, with trust and open communication. That is how nephrology started to change. We need the same kind of honest alignment in transplant if we want to see real progress.

###

If this conversation resonates, we’d love to hear from you. Join the discussion in the comments and share your perspective, questions, or experience.

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Continue learning

• Too Grateful to Complain? A guest essay by Karin Hehenberger MD, PhD on why organ transplantation lags behind oncology in innovation and public voice.

• Life on Immunosuppression. The largest survey of its kind reveals the daily toll of transplant drugs, and the case for rewriting the playbook through advocacy, policy, and innovation.

• Unboxing the next frontier in transplant medicine. A Signals brief on the novel iBox score; how it works; and why it might change the course of decision-making and drug development in kidney transplantation.

• Mapping the Xeno Immune Response With PITOR’s Erwan Morgand and Alessia Giarraputo. How researchers from Paris Transplant Group, NYU, and MGH are using multimodal diagnostics to uncover the earliest immune response signatures in pig-to-human xenotransplantation.

• Signals KOLs with Dr. Ben Hippen, a conversation about IOTA, incentives, and how to build a transplant-inclusive kidney care model.

Refer a friend

Earlier this week, Alexa Mikhail wrote in Second Opinion that if you want to understand how AI will change medicine, look at cardiology. She’s right. Cardiology is out front. But nephrology is rarely far behind, and often already in the room. Thirty to sixty percent of patients with heart failure also have chronic kidney disease. More than half of patients with CKD ultimately die from cardiovascular causes. The cardio-renal link is structural. If AI reshapes one field, the other will feel it.123

Kidney care, however, has its own dynamics. Much of it lives in primary care before it is labeled, if it is labeled at all. It is deeply data-driven yet historically underdiagnosed. Signals accumulate across years and settings before anyone connects them. Most people think of dialysis or transplant when they think of kidney economics, but tens of millions sit upstream of that decision

That combination makes nephrology uniquely dependent on longitudinal pattern recognition. The specialty runs on data; AI simply makes that dependence explicit. What we are seeing across research and commercialization is not a single narrative, but convergence around a handful of clinical and economic realities.

After dozens of conversations with nephrologists, dialysis leaders, startups, payers, and policy experts, and a review of the emerging evidence, I see five recurring themes. They are less about technological novelty and more about economic alignment.

Five Observations

1. Make hidden risk visible

2. Align with payment pathways

3. Prevent high-cost events

4. Move upstream, early

5. Improve the human experience
   

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Observation #1: AI is most believable in kidney care when it makes hidden risk visible early enough to change payment, utilization, or modality.

Kidney disease is expensive long before it is obvious. Chronic kidney disease is frequently underdiagnosed and under-coded, especially in its earlier stages. Much of it lives in primary care, cardiology, and endocrinology before a nephrologist ever sees the patient. By the time someone reaches advanced CKD or dialysis, years of risk accumulation have already passed through the system with little recognition.

That invisibility has consequences, and now shows up in newer payment models. Risk scores can become understated, benchmarks drift, and shared savings opportunities shrink. Effective therapies do exist, but more often than not they’re stuck on the sidelines without adequate guideline-directed treatment plans in place. Patients progress without anyone fully appreciating how fast they are moving. That is the story we all know, and the one we all agree must end.

Figure: Distribution of U.S. adults by eGFR and albuminuria category (USRDS)4

This is where AI’s most credible early contribution lies: not in replacing clinical reasoning, but in surfacing what is already there.

Machine learning models have demonstrated strong performance in predicting CKD progression, identifying rapid eGFR decline, forecasting dialysis initiation, and flagging hospitalization risk. Commercial tools now embed these capabilities directly into longitudinal records to surface undocumented stages and high-risk phenotypes in real time.5

We have seen similar arcs in cardiology and oncology. AI gained traction in heart failure not because it was novel, but because it helped identify decompensation risk before readmission. In oncology, predictive tools became economically meaningful when they influenced protocol adherence and outcomes tied to payment models.

As specialty-based total cost of care models expand, nephrology is increasingly evaluated not just on dialysis volume, but on risk-adjusted performance across the disease continuum (including non-nephrology spend, see below).

Figure: Potential savings from managing high-cost specialties in value-based payment models6

Kidney care is structurally suited to this kind of visibility. It spans long time horizons. It relies on repeated lab measurements. It generates dense data streams across years. The signals are there; they are just scattered. When AI consolidates those signals into actionable risk visibility, it changes three things at once: how patients are categorized, how clinicians intervene, and how payment models interpret performance.

That is why risk visibility is the most believable entry point for AI in nephrology today. It does not require reinvention of care delivery. It requires clearer recognition of what is already unfolding, and alignment with systems that increasingly reward accuracy in documenting and managing that risk. The harder problem is not the AI model itself, it is behavior: awareness, workflow integration, and clinical buy-in.

Observation #2: Durable kidney AI companies will align with existing payment pathways before trying to invent new ones.

The AI applications that have endured in other specialties embedded themselves within existing reimbursement systems rather than attempting to reshape them. Radiology tools improved detection inside established imaging payment models. Diabetes technology scaled once it aligned with covered device and pharmacy benefits. In cardiology, remote monitoring gained traction when reimbursement codes and risk arrangements supported managing heart failure outside the hospital. Then insurers stepped in to pay for more of these devices and scans. In each case, alignment, not novelty, drove adoption.

Figure: Calculator inputs, KPIs, and outputs for the return on investment (ROI) calculator for [Radiology AI App]

Nephrology looks similar in some cases. Kidney care sits within a layered and often fragmented payment landscape that includes traditional Medicare, Medicare Advantage, commercial contracts, bundled dialysis payments, shared savings arrangements, and kidney-specific value-based models. It is not a “clean” system, and it is not likely to become one in the near term. The AI tools most likely to endure are not those attempting to bypass that complexity, but those that work within it. Technologies that integrate into reimbursed diagnostics, improve risk adjustment accuracy under Medicare Advantage, strengthen performance in shared savings arrangements, or measurably influence quality metrics tied to payment are structurally advantaged. Novel algorithms alone are insufficient; clinical performance must intersect with economic relevance.

This is particularly important in nephrology because so much of revenue remains concentrated in advanced disease and dialysis. Any upstream or longitudinal AI solution must demonstrate how it connects back to that downstream financial structure, whether by delaying progression, improving contract performance, or reducing costly acute events. Alignment may not be the most glamorous strategy, but I believe it is the most durable. The companies that recognize this early and build for the system that exists, rather than the one they hope will emerge, are the ones most likely to last.

Observation #3: Preventing expensive events in advanced CKD and dialysis is the most immediate ROI case for kidney AI.

If there is a single area in nephrology where the economic case for AI is most straightforward, it is in preventing expensive acute events among patients with advanced CKD and end-stage kidney disease.

Hospitalizations drive cost in kidney care. Admissions for fluid overload, access complications, infections, cardiovascular events, and missed dialysis sessions are frequent and financially consequential.7 They influence total cost of care under risk contracts, shape shared savings performance, and materially affect margins for providers and payers alike. Unlike some upstream interventions that require long time horizons to demonstrate impact, hospitalization avoidance produces measurable economic effects almost immediately.

Figure: Mean annual per patient health care costs covered by commercial payers and Medicare, stratified by eGFR and UACR (Dark Blue = Hospitalization)8

The literature reflects this focus. Machine learning models have been developed to predict hospitalization risk, intradialytic hypotension, rapid hemoglobin shifts, and other destabilizing events in dialysis populations. Some interdisciplinary programs that incorporate predictive analytics into dialysis workflows have reported reductions in hospitalization rates and shortened hospital stays. AI-supported anemia management has been associated with more efficient ESA utilization and fewer adverse events.9 These findings are still evolving, but the direction is consistent: when predictive insight is embedded into care delivery, trajectories can change.

Other specialties moved here first. Cardiology embraced predictive monitoring in heart failure because readmissions were costly and highly visible under reimbursement reforms. The logic is simple: detect deterioration earlier, intervene sooner, avoid costly admissions. Pulmonary programs adopted remote monitoring when COPD exacerbations proved financially punishing. In both cases, the ROI equation was simple: prevent a costly admission, and the technology begins to pay for itself.

Figure: Remote monitoring (RM) technologies and the potential value of remote management throughout the natural history of heart failure (HF)10

Nephrology shares that clarity. A single avoided hospitalization in a dialysis patient can offset significant operational investment (see above chart). In a risk-bearing environment, reductions in admission frequency or length of stay translate directly into contract performance. Even in fee-for-service settings, fewer destabilizing events reduce downstream complications and improve quality metrics that increasingly influence payment.

This does not mean every predictive model will deliver durable savings. Evidence generation, workflow integration, clinician trust, and operational follow-through remain critical. But of all the domains where AI is appearing in kidney care today, preventing high-cost events in advanced CKD and dialysis presents the cleanest economic logic. It is where clinical risk and financial risk overlap most visibly, and where near-term sustainability is most likely to take hold.

Observation #4: Upstream kidney care is becoming economically viable because of advances in predictive analytics and AI.

For decades, the financial center of gravity in kidney care sat at dialysis. Upstream CKD mattered clinically, but economically it was harder to see. That appears to be shifting, slowly but meaningfully.

Measures like KED (Kidney Health Evaluation for Patients with Diabetes) illustrate the change.11 Albuminuria testing in diabetes is now embedded in Medicare Advantage performance frameworks, making early kidney risk visible in ways that influence plan ratings and incentives. Proteinuria often precedes significant GFR decline. When detected and treated earlier, progression slows and cardiovascular risk falls. The cardio-renal connection is structural: early kidney management affects heart failure outcomes and downstream cost.

Figure: Use of CKD tests by health insurer12

That shift creates a new economic surface for AI. Tools that close albuminuria testing gaps, flag rising risk in diabetic populations, or identify patients eligible for guideline-directed therapies are no longer purely preventive aids. They increasingly intersect with measurable incentives. Earlier recognition affects quality scores, risk adjustment, and long-term cost trajectories under value-based arrangements.

Other specialties followed a similar path. Diabetes platforms scaled once prevention translated into measurable cost reduction.13 Musculoskeletal programs expanded when delaying surgery produced employer savings.14 Prevention became durable once it became financially legible.

Kidney care is entering this phase. Tens of millions of patients sit upstream of dialysis, and their risk is increasingly visible to payers and health systems. AI does not create that shift, policy and evidence do. But AI may make it feasible to build these upstream models at scale.

The open question is leadership. Chronic care management platforms are expanding across cardiometabolic, MSK, heart failure, and diabetes. The writing is on the wall: kidney will not remain siloed indefinitely. Whether the next wave is led by nephrology, primary care, health plans, or diversified chronic care platforms remains unclear. Early signals from ACCESS and similar initiatives may help clarify the direction.15

Observation #5: Administrative AI brings real human benefits, but its financial impact in nephrology remains uneven and its governance questions are just beginning.

Ambient documentation and administrative AI are among the most visible applications of AI in medicine today. Early peer-reviewed evidence supports meaningful clinician benefit, including a recent multicenter quality improvement study in JAMA Network Open that showed a ~14% reduction in burnout and ~6% reduction in severe burnout after adoption of an ambient AI scribe. Clinicians described lower cognitive load and greater ability to focus on patients.

Time savings, however, appear modest. Peak reductions in daily EHR time have reached roughly 20 minutes in some evaluations, while after-hours documentation improvements have been small. The primary benefit may be cognitive relief and patient experience rather than dramatic workflow compression, a theme echoed at last fall’s RPA AI Summit and captured well in Season Two of The Pitt.

In nephrology, the financial implications remain variable. Documentation gains can improve risk adjustment and coding accuracy, but their impact depends heavily on payer mix, contract structure, and whether margin is driven by E&M or bundled dialysis revenue. Administrative AI improves the human experience of care. Its economic durability is more context-dependent.

Figure: Challenges in AI Implementation

At the same time, governance is moving to the foreground. A recent Kidney News editorial highlights growing concerns about algorithm transparency, bias, training data provenance, and the risk of automation without specialty oversight. The American Society of Nephrology’s Responsible AI roadmap underscores this point, calling for clinician involvement in model development, validation in kidney-specific populations, post-deployment monitoring, and guardrails around equity and safety.

This is an important distinction. Administrative AI may improve how nephrologists work. But how kidney AI is governed, validated, and aligned with specialty standards will determine whether it strengthens the field or simply layers new tools onto fragile systems.

Closing thoughts

Kidney care has always been a specialty defined by complex physiology, data-driven decision making, and long time horizons. AI does not change that. What it does is expose where risk is hiding, where incentives are misaligned, and where behavior still slows progress even when evidence is clear. The early signals suggest that durability will not come from novelty alone, but from economic alignment, governance, and clinical trust. To me the question is which use cases will earn the right to stick around.

If you’re building, deploying, using or evaluating AI in kidney care, I’d like to hear from you. Where is it working? Where is it stalling? Where do we go next?

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This month’s news begs a bigger question: what was our kidney care system made for? In the Barbie film, Billie Eilish’s “What Was I Made For?” becomes a quiet reckoning about purpose. The title feels like a fitting frame now. Was this system built to manage late-stage failure, or to intervene earlier? To reward volume, or to align around outcomes? To operate in silos, or to treat cardiovascular, kidney, and metabolic disease as the connected reality they are?

Let’s get into it.

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What’s Inside

• News: ACCESS model details, OPTN modernization update, DCD expansion, HHD innovation, major industry bets, Ivenix recall;

• Research: Finerenone Phase 3 data, precision transplant tools, AI in workflow, upstream CKD screening gains

• Community: RPA preview, AI-ready practices, dialysis innovation debate, CKM unification voices, transplant stories

• Events: World Congress of Nephrology, Renal Physicians Association, NKF Spring Clinical Meetings, ANNA National Symposium, Columbia CKM, and more

• Jobs: Ardelyx, Travere, Strive, Monogram, Takeda, Boehringer, Vertex, Revalia, Trestle, CVS Health, Getinge, Natera + dozens more on jobs.signalsfs.com…

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2026 Reader Survey!

Help shape the future of Signals. We’re expanding across research, data, community, and new tools for the kidney and CKM space. Take 5 minutes to share what would be most valuable to you here. Ten people will receive a $50 digital gift card as a thank you.2

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News

POLICY & REGULATORY

• CMMI’s new ACCESS model introduces outcome-aligned payments for early CKM care. The 10-year voluntary model allows organizations to participate in four tracks, including early cardio-kidney-metabolic (eCKM) and CKM (CKD stage 3a or 3b), shifting Medicare FFS reimbursement from volume to outcome-aligned payments (OAPs). For the CKM track, participants can receive $420 per beneficiary in the initial 12-month period and $210 in follow-on years, with an additional $15 rural adjustment. Payments are tied to clinical improvement thresholds and reduced duplicative services, with semiannual reconciliation and potential downward adjustments if fewer than 50% of patients meet outcome targets. CMS will also introduce a co-management payment (~$30 per beneficiary, quarterly) for care coordination. Advocates say the model signals a serious federal push to fund technology-enabled, accountable upstream CKM management rather than waiting until dialysis. Author’s note: I’ll be writing about this in more depth soon, with performance scenarios tailored for both neph practices and tech vendor partners focused on e/CKM. As a reminder, to be considered for the model’s first performance period beginning July 5, 2026, applications must be submitted via the Participant Portal by April 1, 2026. Applications received after this date will be considered for a January 1, 2027 start.

• HRSA’s February update outlines continued modernization of the OPTN, focused on governance reform, technology infrastructure, transparency, and oversight across the transplant system. Key developments include launch of a new OPTN 411 call line (handling 300+ calls in its first month), expanded financial assistance for living donors with income limits removed, addition of 144 new volunteers to OPTN policy committees, rollout of a government-managed Transplant Data Services (TDS) platform, a new Ventilated Patient Form to improve OPO referral visibility, and forthcoming quarterly public reports on transplant center registration fees. The modernization effort signals continued federal pressure to realign transplant infrastructure with current clinical and public health realities.

• Fresenius Kabi recalled certain Ivenix large volume infusion pumps after a software issue that can delay or interrupt therapy and misreport battery life, prompting the FDA to classify the action as Class I, its highest risk level. The issue has been linked to two serious injuries, and the company is directing providers to update to the latest software version. The recall follows multiple prior safety actions and a 2024 FDA warning letter related to the Ivenix platform, which Fresenius acquired in 2022 for $240 million.

• Healthy People 2030 is calling renewed attention to dialysis vascular access, as central venous catheter use rises and mortality worsens. Despite arteriovenous fistulas (AVFs) being the gold standard, nearly 85% of new dialysis patients start with a catheter, which carries a fourfold higher mortality risk. USRDS data show catheter rates climbing post-pandemic, alongside Medicare reimbursement pressures and Medicare Advantage policies that may delay timely access creation. Advocates argue that reaching catheter reduction goals will require payment reform, stronger support for vascular access centers, and renewed focus on infection prevention. (Healio, H/t Terry Litchfield)

INDUSTRY MOVES

• DaVita announced a strategic investment in Elara Caring to co-develop a kidney-specific home-based care model, signaling a push beyond the dialysis clinic and into coordinated in-home support. The partnership pairs DaVita’s risk-based care arm (IKC), which turned profitable in 2025 and now manages roughly $5.6B in annualized medical spend, with Elara’s multistate home health platform. The goal: reduce preventable hospitalizations and lower total cost of care by building the operating layer around kidney patients at home. It’s a bet that value-based economics can fund the next phase of at-home kidney care. Read my full analysis here.

  

• CareDx announced VANTx™, a cloud-native, AI-powered clinical data and analytics platform built on its large-scale longitudinal transplant datasets, unveiled at the 2026 Precision Medicine World Conference. The platform enables secure cohort analysis across patient timelines to support clinical research, real-world evidence generation, and transplant program insights, integrating de-identified molecular, clinical trial, EMR, and remote monitoring data. Built on Databricks and leveraging Llama 3 and proprietary predictive models (KOAR, SHORE, ALAMO, MAPLE), VANTx is designed to help transplant centers and pharma partners generate actionable insights across kidney, heart, lung, and liver transplantation. (H/t Jenny Sato, Hal Gibson)

• SeaStar Medical reported post-approval data showing its selective cytopheretic device (Quelimmune) was safe and may benefit children with life-threatening sepsis-associated AKI requiring kidney replacement therapy. In the first 21 pediatric patients treated under its FDA humanitarian device exemption, 90-day survival was 71%, with no device-related adverse events reported. The device, which works alongside CRRT to modulate hyper-inflammation, is currently the only FDA-approved therapy for this critically ill pediatric population, with additional studies ongoing in both children and adults. (H/t Kevin Chung)

• Cedars-Sinai performed its first fully robotic kidney transplant, joining a small group of U.S. centers offering robot-assisted implantation for recipients. The minimally invasive approach uses smaller incisions, which may reduce pain, infection risk, and recovery time, particularly for patients with higher BMI who face greater wound complication risk. The program aims to expand robotic procedures to as many as 40% of kidney transplants over the next 3–5 years, while emphasizing that patient selection remains individualized.

• Digital health M&A wave gains momentum in 2026. MedCity News reports a sharp uptick in targeted acquisitions, including Sword Health’s $285M purchase of Kaia Health and OpenAI’s $60M acquisition of Torch, as digital health companies seek scale, AI capabilities, and stronger payer leverage. Investors expect continued consolidation, particularly in primary care, post-acute care, ancillary services, revenue cycle management, imaging/radiology, robotics, and consumer health. With IPO markets uncertain, M&A may become the dominant exit path this year.

DATA & INFRASTRUCTURE

• Springer Nature and GlomCon launch Rare Kidney Diseases journal. Springer Nature will publish Rare Kidney Diseases, a fully open access journal from the GlomCon Foundation dedicated to research and innovation in rare and complex kidney disorders. Submissions are expected to open in early 2026, with a focus spanning clinical insights, pathology, and AI applications.

• AST pushes for iBox biomarker qualification at Congressional briefing. The American Society of Transplantation hosted a Capitol Hill briefing focused on patient-centered innovation in transplant immunosuppression, highlighting the burden of current therapies and the need for safer options. A key priority was FDA qualification of the iBox composite biomarker, developed through the Transplant Therapeutics Consortium, as a reasonably likely surrogate endpoint for long-term kidney graft survival. If qualified under the accelerated approval pathway, iBox could modernize transplant trial design and speed access to new therapies while maintaining scientific rigor. Watch it here. (H/t Kevin Fowler)

• Eledon’s Tegoprubart pilot study in islet transplantation completed enrollment (N=12), with 7 patients achieving sustained insulin independence and the earliest participant remaining insulin-free for up to 18 months. The tacrolimus-free immunosuppression regimen has been well tolerated with no observed toxicity, and a related study in patients with type 1 diabetes and chronic kidney disease is expected to open soon (LinkedIn, h/t Piotr Witkowski)

• Dr. Adebowale Adebiyi at the University of Missouri received a $2.8 million NIH grant to study a newly identified contributor to acute kidney injury in premature infants. His research suggests overactivation of voltage-gated sodium (NaV) channels in kidney blood vessels may restrict oxygen delivery during injury, worsening organ dysfunction. The project will explore how nitric oxide interacts with these channels and whether targeting this pathway could restore blood flow and protect kidney function in vulnerable NICU patients.
  

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Research

THERAPEUTICS

• Finerenone shows first positive Phase 3 data in Type 1 diabetes and CKD since 1993. In a Phase 3 trial published in NEJM, finerenone reduced UACR by 34% over six months in adults with Type 1 diabetes and CKD, compared to a 12% reduction with placebo — a 25% greater reduction overall (P<0.001). eGFR declined modestly at 6 months (–5.6 vs –2.7 ml/min/1.73m²), but values approached baseline after washout, suggesting a hemodynamic effect. Hyperkalemia occurred in 10.1% of finerenone patients vs 3.3% with placebo. This is the first positive Phase 3 trial in this population since the Captopril trial in 1993, and it uses a bridging-biomarker approach to extrapolate albuminuria reductions to long-term outcomes based on prior Type 2 diabetes data. (H/t Robert Lawatscheck, MD, PhD)

• Finerenone reduces heart failure hospitalizations within months, with kidney benefits accruing over time. A participant-level analysis of FIDELITY and FINEARTS-HF published in JACC found that heart failure hospitalization was the earliest event prevented with finerenone. In FIDELITY, sustained statistical significance for HF hospitalization emerged at ~6 months, compared with ~10 months for the composite kidney outcome. In FINEARTS-HF, HF hospitalization reached significance as early as 0.9 months. The findings suggest that finerenone delivers near-term cardiovascular risk reduction, while kidney protection becomes more apparent with longer follow-up, reinforcing the case for earlier implementation in high-risk CKM patients. (H/t Brendon Neuen)

PRECISION MEDICINE

• KPMP biopsy data reveal diagnostic blind spots in diabetic CKD. In a preprint from the Kidney Precision Medicine Project, only 56% of participants enrolled as diabetic kidney disease (DKD) had biopsy-confirmed diabetic nephropathy, underscoring substantial diagnostic heterogeneity. Molecular profiling showed immune and inflammatory pathway upregulation and oxidative phosphorylation downregulation in confirmed diabetic nephropathy, alongside more severe fibrosis and tubular injury. A clinical-biomarker model (age, HbA1c, UACR, KIM-1, sTNFR1) predicted biopsy-confirmed diabetic nephropathy with an AUC of 0.82 and was associated with CKD progression in CRIC (HR 1.48 per 10% higher predicted probability). The findings strengthen the case for precision diagnostics beyond clinical labels alone.

• iBox accurately predicts graft loss in African American transplant recipients. In a multicenter North American preprint study of 3,588 kidney transplant recipients, including 866 African American patients, the iBox prognostication system showed similar discrimination for graft loss across groups (C-index 0.81 vs 0.83; p=0.25) with no significant interaction by race. Although African American recipients had higher baseline risk and a greater 7-year hazard of graft loss (HR 2.14; p<0.001), calibration and overall performance remained robust up to 7 years post-evaluation. The findings support iBox as a relevant surrogate endpoint across diverse transplant populations. (H/t Amanda Klein)

• Microvascular inflammation extends beyond classic antibody-mediated rejection. A review by Alexander Loupy and colleagues highlights that microvascular inflammation (MVI) includes DSA-negative and C4d-negative forms now recognized in updated Banff criteria and linked to worse graft outcomes. Donor-derived cell-free DNA is emerging as a leading noninvasive marker of active injury, and therapies such as CD38-directed agents are under study. The authors call for integrating histology, molecular diagnostics, and AI tools to better classify and treat alloimmune injury. (H/t Alex Loupy)

• A new review in Kidney News outlines rapid automation and design advances across seven FDA-approved home hemodialysis (HHD) machines, highlighting features such as on-demand dialysate production, cloud-based monitoring, automated saline flushes, and enhanced needle dislodgement detection. Despite rapid device innovation, only 0.4% of incident kidney failure patients initiate HHD in the U.S., underscoring that technology alone hasn’t shifted modality adoption.. (H/t Osama El Shamy)

Figure: Comparison of conventional HD with the low dialysate volume approach

AI & REAL-WORLD EVIDENCE

• Clinical Kidney Journal lays out a roadmap for AI integration in nephrology.
  A new state-of-the-art review outlines how AI is moving from pilot projects to clinical integration across AKI, CKD, dialysis, and transplantation. Predictive AKI models, CKD risk stratification tools, AI-enabled dialysis management, and transplant platforms such as iBox are highlighted as leading use cases, though workflow integration and real-world validation remain uneven. The authors flag data bias, interpretability, and regulatory uncertainty as key barriers, and point toward multimodal data integration, reinforcement learning, and digital twins as the next frontier in precision nephrology. (H/t Davide Garrisi)

• A new preprint shows that simple EHR design changes dramatically improved albuminuria screening in patients with hypertension. At Geisinger, UACR testing rose from ~3% in 2020–2021 to 9.7% in 2022 and 17.5% in 2023 after implementing two clinical decision support tools, compared to only ~3% in control health systems. An initial advisory increased testing roughly 3-fold, while a redesigned health maintenance prompt drove ~6-fold improvement from baseline. The findings suggest that thoughtful CDS design, not just guideline awareness, can meaningfully close upstream CKD screening gaps. (H/t Alex Chang)

• AI-triggered interventions reduced short-term hospitalizations in ESKD. A Medicare- and EMR-linked analysis in NEJM Catalyst evaluated AI models that flagged dialysis patients at risk of hospitalization within 7 days for fluid or infection-related events. Among 10,294 patients and 83,928 risk scores, AI-triggered case reviews were associated with an 8% reduction in the odds of hospitalization. The effect was strongest in patients with moderate-to-high risk scores and not significant in the highest-risk group. The findings suggest targeted, workflow-integrated AI may help bend near-term admission risk in value-based kidney care settings.

EPIDEMIOLOGY

• Oral disease tracks closely with CKD progression and systemic inflammation.
  A BMC Nephrology narrative review synthesizing observational studies and trials finds that periodontal disease severity rises alongside CKD stage, with higher DMFT scores and clinical attachment loss correlating with lower eGFR and elevated CRP and IL-6. Non-surgical periodontal therapy modestly improves inflammatory markers, though renal outcomes remain mixed. The authors argue oral health is a measurable, modifiable contributor to CKD progression and call for integrating dental assessments into routine nephrology care, particularly in low-resource settings where fragmentation is most pronounced. (H/t Prakash Gudsoorkar)

• A review in Nature Reviews Nephrology highlights how social determinants of health (SDoH) shape acute kidney injury (AKI) risk and outcomes worldwide. Factors such as socioeconomic status, race, education, environmental exposure, climate change, and conflict influence AKI incidence, recognition, access to care, and long-term outcomes, with disparities widening in low-resource settings. Pediatric populations face unique vulnerabilities, and gaps in data further limit targeted intervention. The authors argue that reducing AKI burden will require policy reform, interdisciplinary strategies, and alignment with broader public health and Sustainable Development Goals to address structural inequities driving disease risk. (H/t Rolando Claure Del Granado)

• A large study in Nature Communications Medicine found that COVID-19 infection is associated with significantly higher kidney risk compared to influenza. In more than 3 million working-age adults, COVID-19 was linked to increased rates of acute kidney injury, chronic kidney disease, end-stage kidney disease, and glomerular disease, while influenza showed no significant association with CKD or ESRD. AKI risk was highest in the short term, while CKD risk persisted over time. The findings support closer kidney monitoring after SARS-CoV-2 infection.

TRANSPLANT TRENDS

• Global transplants hit record high in 2024, but access gaps persist. The Global Observatory on Donation and Transplantation reports 173,727 solid organ transplants worldwide in 2024, a 2% increase from 2023 and the highest number ever recorded. Growth was largely driven by deceased donation, with donations after circulatory determination of death accounting for 28% of all deceased donor activity (47,180 total deceased donations). Despite progress, major geographic disparities and ongoing organ shortages remain central global challenges.

• DCD donation continues to expand in the U.S. A research letter in JAMA reports growing use of donation after circulatory death (DCD) as transplant programs respond to persistent organ shortages. Although DCD organs carry higher risks of dysfunction and require more complex recovery logistics than donation after brain death, technological advances and mounting demand have driven increased adoption. The findings highlight DCD as a key lever for expanding the deceased donor pool in the U.S.

• A companion JAMA perspective piece traces the broader evolution of deceased organ donation, from the 1968 Uniform Anatomical Gift Act to the modern transplant system — offering historical context for how today’s DCD expansion fits into decades of policy and infrastructure development. (H/t Aleah Brubaker & Gabe Schnickel)

• A prospective study in American Journal of Transplantation found that eliminating allocation out of sequence (AOOS) for 30 days increased kidney nonuse. When one OPO (New England Donor Services) strictly followed the national match-run without rescue pathways, nonuse rose from 29.1% to 43.2%, particularly among higher KDPI (more medically complex) kidneys. An estimated 13 additional kidneys might have been transplanted during the study month if prior utilization rates had held. The findings suggest that removing AOOS without a standardized national rescue alternative may increase organ wastage and highlight the need for transparent, policy-driven solutions for hard-to-place kidneys. (H/t Alex Glazier)

• Patients favor flexibility in automated peritoneal dialysis prescriptions. In a national survey of 203 people on automated peritoneal dialysis (APD), most respondents reported starting PD at 7 days per week (73%), yet preferences leaned toward more flexible, incremental approaches that reduce treatment burden. Incremental APD options such as fewer weekly sessions, shorter cycler time, or eliminating daytime dwells were ranked based on perceived impact on quality of life. The findings reinforce that incremental PD is not just clinically viable but aligned with patient-centered care, emphasizing life participation alongside adequacy metrics. (H/t Michael Spigler)

Community

INNOVATION MILESTONES

• Roivios enrolls first European patient in GRADIENT pivotal study. The GRADIENT trial (NCT07017933) evaluating the JuxtaFlow® Renal Assist Device has enrolled its first patient in Europe, marking a key milestone for the company and its partners at American Heart of Poland. The study is testing whether perioperative use of the device can help sustain or enhance kidney function during high-risk procedures. Congrats, team!

• ARPA-H launched ADVOCATE, a new “agentic AI” program aimed at delivering autonomous specialty heart failure care to address clinician shortages, with 46% of U.S. counties lacking a cardiologist. The initiative seeks FDA-authorized AI systems that can provide direct patient care, prescribe medications, integrate with EHRs and wearables, and operate under a novel supervisory AI oversight model. If successful, ADVOCATE could create a regulatory and deployment blueprint for AI-enabled specialty care beyond cardiology, with projected savings of $50B annually. (H/t Haider Warraich)

• Blake Madden spotlights Arbital Health’s “Actuarial AI” for VBC. In a new Hospitalogy deep dive, Blake Madden highlights how Arbital Health is building a real-time actuarial operating system for risk-bearing organizations. Its Merlin AI assistant integrates contract logic, claims data, and predictive models into auditable next-best actions built for actuaries and finance leaders. The argument: VBC struggles less from vision and more from missing infrastructure. I think that’s a message many of my VBC readers can relate to (see our recent report here).

• A Q&A in Healio highlights the University of Washington’s inpatient “Kidney-Heart” service, a specialized cardio-nephrology model for patients with complex cardiovascular-kidney-metabolic disease. In its first 2.5 years, patients treated under the service had lower rates of AKI dialysis (36.7% vs. 42%) and mortality (16.5% vs. 25%) compared to a prior general nephrology cohort. The program embeds nephrologists with cardiac expertise directly into cardiology and cardiac surgery teams to improve early diuretic management and interdisciplinary coordination. Leaders say the model is feasible with sufficient patient volume and institutional support, and are now expanding into a multidisciplinary outpatient clinic.

PROFESSIONAL DEVELOPMENT

• Katie Kwon outlines what to expect at this year’s RPA Annual Meeting (April 16–19, Atlanta), including a new AI-Ready Nephrology Practice certificate, clinical research programming for private practices, and policy discussions with MedPAC Chair Dr. Michael Chernew. The agenda blends practical clinical updates with candid conversations on payment, workforce, and practice management. Will I see you there? Register here.

• ASN launches AI-focused podcast for nephrology leaders. The American Society of Nephrology has introduced Rewired: Navigating AI’s Role in Kidney Health, hosted by Karandeep Singh and Navdeep Tangri. The first episode explores generative and agentic AI and how these technologies are beginning to shape nephrology practice.

• NephMadness 2026 is officially underway! The free, CME-granting, evidence-based tournament (inspired by March Madness) pits top nephrology topics against each other, from IgA nephropathy (B-cell targets vs complement inhibitors) to AI (computational pathology vs NLP) and transplantation (BK vs CMV). This year features eight regions with two subtopics each, blending serious science with creative flair. Brackets are due by March 31 at 3pm ET. Submit your picks here. (H/t Kenar Jhaveri)

  

ADVOCACY / SYSTEM VOICES

• In Health Affairs, Dr. Suzanne Watnick argues that U.S. dialysis has become an “innovation desert” despite being uniquely positioned for research. Nearly 500,000 patients receive highly standardized, data-rich care, yet core treatment protocols have changed little since the 1980s, shaped in part by Medicare’s bundled payment system and industry consolidation, with two for-profit companies controlling ~80% of the market. Although kidney disease costs the federal government more than $150 billion annually, it receives less than 2% of NIH funding, limiting transformative research. She calls for congressional and CMS action to realign incentives, including broader value-based payment models across CKD and transplant, financial incentives for research participation, regulatory support for pragmatic trials, modernization of dialysis IT infrastructure, and reimbursement pathways that explicitly reward innovation rather than cost neutrality.

• ASN’s #LoveYourKidneys campaign ramps up national media push. ASN President Samir Parikh and the ASN team recently wrapped a 17-interview satellite media tour spanning local and national outlets, including CBS News Radio, CNN Newsource, and iHeartRadio, to promote kidney health awareness ahead of National Kidney Month. The campaign bridges the transition from American Heart Month and aims to elevate public understanding of kidney disease risk, prevention, and early detection. Great work Samir, Christine, Tony and Zach— let us know if you’ve seen the message in your local area!

• ASSENT launches push to validate surrogate endpoints in Alport syndrome.
  The Alport Syndrome Foundation’s ASSENT Initiative (Alport Syndrome Surrogate Endpoint Network) is building an international effort to establish evidence-based surrogate endpoints to accelerate clinical trials in rare kidney diseases. Led by a multidisciplinary steering committee, including Committee Co-Chair Dr. Alex Chang, ASSENT brings together patients, regulators, nephrologists, statisticians, and global datasets to evaluate markers such as proteinuria and eGFR as trial endpoints. With multiple rare kidney trials underway across Alport syndrome, ADPKD, IgA nephropathy, AMKD, FSGS, and C3G, now is the time to shorten timelines and strengthen the path to approval for targeted therapies!

• Viet Le calls for unified CKM care, not siloed disease management. In his recent LinkedIn perspective, Viet Le shares that cardiovascular-kidney-metabolic (CKM) syndrome now affects ~90% of U.S. adults, yet we continue to treat A1c, eGFR, and LDL-C in isolation. He lays out a practical framework for staging CKM 0–4, aligning therapy early, and using cross-organ pillars including RAS inhibition, SGLT2 inhibitors, nonsteroidal MRAs, and GLP-1 therapies. The core message: CKM is a shared disease state, and fragmented care is the real risk factor.

TRANSPLANT STORIES

• Former Bengals All-Pro Willie Anderson underwent a successful kidney transplant this month, with his longtime girlfriend serving as his living donor.

• Alex Berrios received a kidney transplant in New York City this month and is now recovering post-surgery (post). After years on dialysis, he shared updates from the hospital and thanked his family for supporting him through the first days of recovery.

• Ben Street, a kidney advocate and OPO leader in San Diego, is seeking a living kidney donor as his kidney function declines to 9% (post). Ben works with UCSD’s Lifesharing and serves as a National Kidney Foundation Region 9 leader, and is asking the community to share his story to help find the right donor match. Apply to be Ben’s donor here.
  

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Events Calendar

• Kidney Cancer Patient Summit, March 15 / San Diego, CA

• CKD Drug Development Summit, March 16-18 / Boston, MA

• LSI USA ‘26, March 16-20 / Dana Point, CA

• WCN, Mar 28-31 / Yokohama, Japan

• RPA Annual Meeting, Apr 16-19 / Atlanta, GA

• ANNA National Symposium, April 25-28 / New Orleans

• Columbia CKM: Evolving Frontiers May 1 / Virtual

• NKF Spring Clinical Meetings, May 6-10 / New Orleans

• NephCure Support Groups (Ongoing)
  

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Jobs

• Nephrologist (Miami, FL) — Kaüna (Say hello!)

• Manager, State Government Affairs — Takeda

• Director, Partner Success — Strive Health

• Sr Analyst, Medical Economics — Monogram Health

• Senior Product Manager, Clinical AI — CVS Health

• Director, Alliance Management — Ardelyx

• Organ Health Specialist (Albany) — Natera

• Sr. Medical Director (Nephrology) — Travere

• Director, Donor Recovery — Donor Network of AZ

• Early Pipeline Forecasting — Vertex

• Analytics Technical Product Manager — Aledade

• Health AI Product Manager — UC San Diego Health

• Director of People — Avo

• Director, Transplant Services (Norfolk, VA) — Sentara

• Globalization Product Manager — Getinge

• …plus hundreds more at jobs.signalsfs.com

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Eight months ago, I published Five Charts That Explain the Current State of Kidney Care. It was an attempt to paint a clear picture of where the kidney world stood at that moment. As you may remember, the story was mixed. Real progress in some areas, stubborn inertia in others, especially early screening, home dialysis, and living donation.

Today kicks off Kidney Month. The burden of kidney disease remains enormous, and hundreds of millions of people still do not know they have it. But as I look across therapeutics, value-based care, primary care integration, and federal payment policy, the center of gravity feels different. The dialysis-centric story is no longer the only one shaping the conversation. Kidney care is being pulled upstream, earlier in the disease journey, and more tightly into cardiometabolic strategy. It’s early, but the signs are there.

We see it in prescribing patterns. We see it in risk-bearing contracts. We see it in how health systems and primary care groups are beginning to think about CKM populations as a risk profile rather than a collection of siloed diagnoses scattered across the medical record. Yes, it’s early innings, but the question is no longer whether kidney disease matters to the broader system. It is shifting to how quickly the system can reorganize around that reality, and who will lead the charge.

So this Kidney Month, I want to highlight four areas that give me reason for optimism. Not because the story is finished. It is not. But because the step-by-step direction of travel from here is already clearer than it was this time last year.

What’s Inside

1. Kidney moves upstream into CKM strategy

2. Risk-bearing care scales beyond nephrology

3. Primary care becomes the leverage point

4. Federal models continue to iterate

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#1

First, the kidney is now at the center of cardio-metabolic care. For years, chronic kidney disease sat as an afterthought, downstream of diabetes, heart disease, and obesity. That dynamic has shifted considerably, with recent examples from the Super Bowl and the American Heart Association’s CKM Initiative reinforcing the message. But the shift is most visible in medication management. Considering most adults with CKD stages 3 to 5 are still more likely to die than progress to kidney failure, any movement toward earlier detection and treatment is meaningful.1

The 2025 USRDS Annual Data Report shows how prescribing patterns have evolved over the last decade.2 While traditional diabetes drugs have steadily declined, SGLT2 inhibitors and GLP-1 receptor agonists have accelerated since 2018. Nearly one in five Medicare beneficiaries with CKD and diabetes were receiving an SGLT2 inhibitor in 2023, and uptake was even higher among those who also had heart failure. GLP-1 use has followed a similar upward trajectory. Even among patients with stage 4 and 5 CKD, these newer classes are increasingly part of the treatment mix.

Figure: Percentage of older adult Medicare FFS beneficiaries with CKD and type 2 diabetes receiving diabetes medications, 2013-2023

These trends reflect more than incremental changes in diabetes care. They track closely with major cardiovascular and renal outcomes trials that established SGLT2 inhibitors and GLP-1 receptor agonists as organ-protective therapies.3 Clinical guidelines have incorporated those findings across specialties. The ADA and KDIGO emphasize early use in high-risk populations. The AHA now includes kidney function in its updated cardiovascular risk algorithm. Kidney endpoints are embedded in cardiovascular trials, and cardiovascular outcomes are central to renal studies. The therapeutic goal has shifted from glucose control alone to preservation of heart and kidney function across a connected cardio-kidney-metabolic axis.4

But who is actually writing these prescriptions? National prescribing data show that cardiology, primary care, and endocrinology account for the vast majority of SGLT2 and GLP-1 use, with nephrology representing only a small fraction of overall volume (see below).5 The inflection in prescribing aligns closely with major outcome trials and subsequent label expansions (here, here, and here). Kidney protection is being absorbed into mainstream cardiometabolic practice rather than remaining siloed within nephrology.6

Figure: (A) SGLT2 and (B) GLP‐1 use across clinician specialties

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Adoption remains uneven. Patients with CKD who do not also carry diagnoses of diabetes or heart failure still have very low exposure to these agents. That’s important because many adults with advanced CKD do not see a kidney doctor. In 2023, only 41% of adults with Stage 5 CKD had a nephrology visit. But the direction is clear. Kidney preservation is no longer confined to specialty clinics. It is increasingly part of routine risk management in primary care and cardiology.

When cardiologists, endocrinologists, and primary care physicians are actively prescribing therapies that slow kidney decline, responsibility for CKD no longer sits with one specialty. That shared ownership is foundational to the integrated risk models now expanding across the country, especially as models differ in terms of who ultimately manages the outcomes and costs of that care.

#2

Second, integrated care is scaling through a specialty lens. The growth in kidney value-based care over the past several years is significant. In our latest review of the landscape, ten leading kidney-focused value-based organizations collectively manage more than 1.5 million patient lives and nearly 40 billion dollars in annual managed medical spend. That figure has roughly doubled from prior updates and now represents about 20 percent of fee-for-service Medicare spending across CKD and ESRD populations.

By our count, the number of lives under management has grown by nearly 50 percent in just the past year. Today, close to one-third of kidney disease patients are cared for within some form of value-based arrangement. Contract design varies greatly, but the scale alone is notable. Kidney care, long viewed as fragmented and reactive, is increasingly being managed under structures that hold organizations accountable for total cost of care. The financial risk is shifting from public to private payers; and further, from larger payers to specialized risk managers in the form of these VB kidney care entities (and not just in nephrology).

Figure: Ten companies manage ~1.5M patients and $37B in annualized medical spend across value-based nephrology models

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Equally important is how these organizations are evolving. The largest players, including Somatus at roughly 500,000 lives, Panoramic at 330,000, Monogram at 200,000, and both Strive and Interwell at approximately 145,000 each, are no longer operating as kidney-only entities. Several have expanded aggressively into cardiology and broader multi-chronic populations. The top three now account for roughly two-thirds of total lives under management, and the mix increasingly reflects patients with overlapping heart failure and metabolic disease.

The financial layer reinforces this integration. Among providers reporting this data, estimated managed spend per patient ranges from roughly $15,000 to $75,000 annually, with an average near $33,000. That range reflects differences in acuity and contract structure, but it also illustrates the economic surface area under management. When tens of billions of dollars in annual spend sit inside risk-bearing arrangements for a population that historically represents one-quarter of Medicare spend, the importance of care coordination cannot be overstated.

The story is not simply that value-based care is growing. It is that kidney value-based care is integrating outward and aligning with cardiology and primary care in the process. The unit of accountability is shifting from the dialysis chair to the whole patient. But that shift raises a natural question. Is it happening in the other direction, and if so, what is driving it?

#3

Third, primary care remains best positioned to stop kidney disease in its tracks. If CKD is going to be detected earlier and managed differently, primary care has to be center stage. It is where most patients with diabetes, hypertension, and cardiovascular disease already receive care, and where early-stage kidney risk is most likely to surface. Yet despite clear guidelines, the gap persists. The recommended tests, estimated GFR and urine albumin-to-creatinine ratio, are inexpensive, widely available, and embedded in most lab panels. They are guideline recommended for high-risk populations. Still, fewer than half of people with diabetes receive both tests, and albuminuria testing among patients with hypertension alone remains strikingly low. The tests are cheap, available, guideline recommended, and still not happening.

Figure: Proportion of people with chronic kidney disease (CKD) who are aware of their diagnosis and are receiving appropriate guideline-recommended care

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Even when labs are ordered, CKD often remains invisible inside the medical record. Prior analyses suggest that nearly 80 percent of patients with moderate CKD lack a formal diagnosis in their chart. Risk is present but unmanaged, and referrals are inconsistent. The result is predictable: sixty percent of patients still initiate dialysis through an unplanned hospitalization, a moment that is clinically destabilizing and financially expensive.

Figure: Average Medicare spending on patients initiating dialysis, 2017-2018

The economic consequences are clear. Data from Kidney Medicine show a sharp spike in inpatient hospital spending in the first 30 days of dialysis initiation, with per patient monthly costs far exceeding later periods. Federal spending on kidney failure now exceeds $50 billion annually.7 Hospitals often lose money on Medicare dialysis patients, and care remains fragmented across dialysis clinics, transplant centers, vascular access programs, and primary care. No single provider has holistic responsibility. Perhaps health systems should.

The question is whether the surrounding model makes prevention rational. In fee-for-service environments, screening and coordination can feel like friction. When a health system or primary care organization assumes responsibility for total cost of care, the equation changes. Avoiding unplanned starts, reducing hospitalizations, and coordinating specialty care move from being aspirational goals to economic imperatives. Models like ChenMed and Intermountain demonstrate how aligned incentives, embedded specialty access, and kidney-focused navigation can translate early detection into smoother transitions and fewer crisis-driven dialysis starts.

Primary care can anchor this shift, but only if it operates inside an integrated model that aligns clinical responsibility with financial accountability. That is where policy and payment design begin to matter most.

#4

Federal payment models are increasingly aligned with the clinical reality of kidney and cardiometabolic diseases. For more than a decade, CMMI has tested ways to move kidney care away from reactive dialysis spending and toward earlier, coordinated intervention. The pattern is not random. It reflects a steady recognition that late-stage payment structures produce late-stage care. If prevention is the goal, accountability has to move upstream to intervene earlier in the disease progression.8

Figure: Annual CKD Costs By Stage (2007-2012)

The ESRD Treatment Choices model focused on home dialysis and transplant incentives. Kidney Care Choices pushed further by bringing advanced CKD and transplant populations into risk-based arrangements. The model was extended through 2027, giving participants additional runway to translate infrastructure investments into measurable results. In its second performance year, 15 of 21 outcomes moved in a favorable direction (see below), with roughly half of eligible patients, about 225,000 people, aligned to KCC. The lesson was not that transformation is easy. It was that building care coordination, analytics, and staffing capacity requires upfront capital before downstream savings appear.9

Figure: KCC Model Outcomes, Second Performance Year (2023)

At the same time, kidney policy has been embedded inside broader accountable care structures. Chronic disease management cannot be isolated from primary care, cardiology, and population health systems. When kidney risk sits inside total cost of care arrangements, the incentives shift. Hospitalizations, unplanned dialysis starts, and transplant delays are no longer siloed specialty problems. They become financial events for the entire organization.

The next generation of models continues that evolution. ACCESS builds on kidney-specific coordination lessons by extending tech-enabled accountability earlier into CKM risk (CKD stages 3a and 3b), while LEAD introduces a ten-year accountable care pathway with improved benchmarking, population-based payments, and a focus on high-needs and dually eligible patients. A longer runway changes behavior. Organizations are more likely to invest in prevention when the contract horizon matches the biology of chronic disease. Digital tools and outcomes-aligned payments may make earlier, lower-touch interventions economically viable at scale.

Taken together, these models show that CKM is not only a clinical framework. It is becoming embedded in payment architecture. Public models often set the direction for how private payers structure risk, including Medicare Advantage and commercial plans. This broader coordination across payers is often referred to as multi-payer alignment, and it matters. When Medicare, Medicaid, and private insurers align around common measures, payment approaches, and data-sharing standards, it becomes easier for providers to invest in prevention and integrated care. When federal policy begins to price prevention, integration, and long-term accountability, the broader market tends to follow. Over time, the financial system begins to reflect the biology of chronic disease rather than react to its complications.

Note: I’m working on a piece for participants in the ACCESS model, with a few modeled scenarios for the e/CKM tracks. Please reach out if you’d like to share any insights, comments, or questions.

Forward, March

This Kidney Month, I am encouraged by how far the system has moved in the short time I’ve been paying attention.

And yet, real gaps remain. Data still struggles to move cleanly across the ecosystem: primary care, cardiology, nephrology, dialysis, and transplant. Attribution models can blur responsibility rather than clarify it. Many practices lack the physician-level tools, analytics, and care team support needed to manage CKM risk in real time. Incentives may be aligning, but operational capacity is still uneven.

These are not reasons for skepticism. They show us where to focus next. I am hopeful we will get there because of the hard work of so many of you across this ecosystem. Thank you for what you do and for helping move this progress forward.

I’d love to hear from you. What is making you optimistic right now, and what are you celebrating this Kidney Month?

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