We follow more than 200 companies across the kidneyverse. Each quarter, we’ll pull out the results that matter most across diagnostics, therapeutics, dialysis, care delivery, and payers. We’re starting with seven: Natera, CareDx, Outset Medical, DaVita, Fresenius Medical Care, Humana, and UnitedHealth.

There was plenty happening beyond the earnings calls this quarter, too. CMS finalized a Medicare coverage decision expanding transplant surveillance testing, while its proposed CY2027 ESRD payment rule could reshape TDAPA economics across dialysis. We’re also using this cycle to update our kidney VBC dataset, beginning with new results from DaVita’s Integrated Kidney Care business below.

Subscribe now

Q2 2026

• Natera (reported Aug 6): Revenue hit $753M, up 38% year-over-year, on record test volumes of 1.04 million. Clinical MRD/Signatera volume jumped 56%, management raised full-year guidance to $2.85 to $2.91B, and shares climbed 16% after hours. Market cap has more than doubled over the past year, from about $20B in August 2025 to $45B as of August 10th.1 The quarter also came on the heels of a finalized Medicare local coverage determination that expands surveillance coverage for Prospera kidney testing to 6 tests in year one and 4 per year in years two and three, a meaningful reimbursement tailwind for the organ health franchise heading into Q3, one that also extends to CareDx, which reported July 30 (more below).

• Outset Medical (reported Aug 6): The company signed a three-year, $40M agreement with HCA Healthcare to refresh its existing Tablo fleet, its first refresh deal to date. CEO Leslie Trigg said the quarter also included the company's highest number of new site installations in several years. Revenue grew 1% year-over-year to $31.6M (up 14% sequentially), gross margin expanded over 400 basis points to 42.0%, and net loss narrowed slightly to $18.0M. The company held $151M in total cash after using $9.5M during the quarter. Full-year guidance was reiterated at $125 to $130M.

• DaVita (reported Aug 4): Revenue of $3.554B (up 5.2% Y/y) and adjusted EPS of $4.02 beat estimates, though shares still fell about 7.5% on the print. U.S. treatment volume ticked up too: DaVita performed 7.2 million dialysis treatments in the quarter, averaging 92,649 per day, a modest increase from Q1. IKC, DaVita's value-based kidney care arm, generated $40M in adjusted operating income in Q2, up from a $19M loss in Q1, per management commentary on the earnings call. On policy, DaVita flagged that CMS's proposed CY2027 ESRD PPS rule (released late June) tracks below industry cost trends amid complex TDAPA dynamics; the company is submitting comments, with the ultimate impact hinging on the final rule due later this year. CEO Javier Rodriguez pointed to hemodiafiltration (HDF) and the recently FDA-approved expanded HD option from NIPRO, with DaVita planning to deploy the compatible dialyzers across its network in coming quarters after its MOTheR trial showed expanded HD performs comparably to HDF on mortality and cardiovascular outcomes. The company reaffirmed full-year guidance. Find our 4Q 2024 earnings updats here.

• Fresenius Medical Care (reported Aug 3): Adjusted operating income grew 23% (margin expanding to 11.7%) on 5% organic revenue growth, though reported (GAAP) operating income grew a more modest 10% and net income fell 3%. Value-Based Care revenue grew 9% organically to €536M ($617M), with segment operating income swinging to €18M ($21M) from a €9M ($10M) loss a year ago; management guided full-year VBC to land around breakeven. The company's 5008X CAREsystem rollout expanded to 227 U.S. clinics and more than 600,000 treatments, with roughly 170,000 of those using hemodiafiltration, including over 100,000 high-volume HDF treatments, and early data from its BEACON-US research initiative showing 40% fewer muscle cramps. Fresenius reaffirmed full-year guidance.

• CareDx (reported Jul 30): Revenue jumped 52% year-over-year to $132M, driven by a 61% rise in testing-services revenue and 17% growth in testing volume to 58,000 tests. GAAP net income swung to $111M from a $9M loss, though that includes a one-time $113M gain from selling its Lab Products business; the company also closed its acquisition of Naveris, adding the NavDx oncology platform. CareDx raised full-year 2026 guidance to $490 to $500M in revenue and $66 to $78M in adjusted EBITDA. Like Natera, CareDx benefits directly from the finalized Medicare LCD affirming AlloSure Kidney coverage for up to six surveillance tests in year one, reducing reimbursement uncertainty right as demand accelerates.

• Humana (reported Jul 29): Individual Medicare Advantage membership grew by roughly 1.2 million members, or 23%, year-to-date, tracking toward Humana's full-year target of about 25% growth. Adjusted EPS of $7.61 came in at the high end of guidance, with management citing cost favorability concentrated among members in value-based care arrangements; the company affirmed full-year adjusted EPS guidance of at least $9.00. CenterWell Primary Care also grew fast, up 27% to roughly 622,000 patients, aided by the MaxHealth acquisition. Humana’s Stars program metrics improved faster than their historical trend on 11 of 12 tracked measures, as the company works toward top-quartile Stars performance by 2028, a sharp contrast to UnitedHealth's shrinking MA book this same quarter. Find our 2024 Humana Kidney VBC update here.

• UnitedHealth Group (reported Jul 16): Adjusted EPS rose 56% year-over-year to $6.38 as the medical care ratio improved to 86.7% from 89.4%, and the company raised full-year adjusted EPS guidance to $19.50–$20.00. Revenue of $112B was roughly flat. The company’s own language is the most directly value-based-care of any payer this quarter: Optum Health’s release describes the business “recenter[ing] on its integrated value-based care” model, even as Optum Health revenue fell 5% on roughly 700,000 fewer value-based care patients served. Seniors served through Medicare Advantage, including programs serving complex populations covered under Medicaid, contracted by 965,000 since year-end 2025, per the release. Worth tracking as the ACO/risk-based-contracting story develops into ACO LEAD next year. For scale: UnitedHealth’s market cap of roughly $380B is about 3x the combined value of the other six companies in this brief, as of Aug 10, 2026.

Up next

That's the first seven earnings updates from Signals. Tell us what you think, we want to improve our coverage and depth, and make sure we're capturing what these market moves mean for the broader kidney space. Our coverage will rotate each quarter, so the next cycle will bring in more payers, pharma developing therapies for this population, care delivery companies, and other names across the 200+ companies we track.

What are you watching in Q3? Drop a comment below.

Leave a comment

Share

1

https://companiesmarketcap.com/natera/marketcap/

Your curated list of high priority roles across the kidneyverse, delivered straight to your inbox every month. This edition features 11 senior roles across R&D, provider enablement, sales, AI, and population health.

Subscribe now

At A Glance

• Director, Provider Enablement (Interwell Health)

• Medical Director, UM (Gold Kidney Health Plan)

• TLL, Rare Nephrology, North Central (AstraZeneca)

• Adv Account Manager – Nashville (Mozarc Medical)

• Healthcare AI Startups Lead, APAC (NVIDIA)

• Manager, Biomedical Services (Innovative Renal Care)

• Director, Clinical Support Services (Monogram Health)

• Director, Population Health Impact (Aledade)

• VP, Clinical Development (ProKidney)

• Dir, Patient Services Strategy, Rare Neph (Alexion)

• Lead, Health Economics & Outcomes Research (Novartis)
  

  Browse all jobs

Open Roles

1. Interwell Health is hiring a Director, Provider Enablement Success (Multiple locations, Remote) to lead the Acumen® Support and Training functions and mature the provider enablement organization as it scales. Reporting to the VP, Provider Operations & Strategy, this newly created role owns support, training, and customer communications strategy for Interwell Acumen™, the nephrology-specific Epic Connect EHR, working closely with Product, Implementations, and Account Management. Candidates should bring 10+ years in customer success or enablement within healthcare technology, prior Epic experience, and a track record leading cross-functional operational improvement. Apply here.

2. Gold Kidney Health Plan is hiring a Medical Director, Utilization Management (United States, Remote) to provide physician oversight of inpatient and outpatient utilization management for its Medicare Advantage Chronic Condition Special Needs Plan. The role makes medical necessity determinations across prior authorizations, concurrent reviews, retrospective reviews, and appeals, applying CMS coverage guidelines and MCG Care Guidelines. Candidates should bring 5+ years post-residency clinical practice, prior Medical Director experience, and a background in Medicare Advantage managed care and UM accreditation standards (NCQA/URAC). Apply here.

3. AstraZeneca is hiring a Thought Leader Liaison, Rare Nephrology, North Central (Chicago, IL, On-site) to lead commercial KOL relationship engagement and promotional speaker training across the region, reporting to the Director, TLL. The field-based role executes patient program support and requires deep clinical fluency in complex disease states alongside strategic execution under tight timelines. Candidates should bring 7+ years across academia, medical, or bio/pharma, prior thought leader engagement experience, and willingness to travel 50%+ within the territory. Apply here.

4. Mozarc Medical is hiring an Advanced Account Manager (Nashville, TN, On-site) to drive sales for its expanding Renal Access portfolio of clinically differentiated technologies. The role partners directly with clinicians and patients while building territory relationships within a global medical technology organization. Candidates should bring a bachelor's degree, 4+ years of B2B or healthcare sales experience, and medical device sales experience. Apply here.

5. NVIDIA is hiring a Healthcare AI Startups Lead – APAC (Beijing or Shanghai, On-site) to build and scale programs connecting regional healthcare and life sciences AI startups to NVIDIA's technology through Inception, accelerators, and regional hubs. The role also engages VCs and funding entities across APAC to accelerate startup adoption, while serving as NVIDIA's regional subject matter expert and interface with global teams. Candidates should bring 10+ years developing startup engagement or developer relations programs at scale, with deep familiarity in APAC HCLS startup and VC ecosystems. Apply here.

6. Innovative Renal Care is hiring a Manager of Biomedical Services - Dialysis (Texas, Hybrid) to lead biomedical operations across multiple dialysis clinics, overseeing equipment performance, water treatment systems, and multi-site readiness. The role also manages biomedical staff development and coaching while ensuring regulatory compliance across varying clinic needs. Candidates should bring 2-4 years of technical and management experience in dialysis, including machine maintenance and water treatment systems. Apply here.

7. Monogram Health is hiring a Director, Clinical Support Services (Brentwood, TN, On-site) to drive strategic and operational execution across all Clinical Support Service functions, ensuring workflows are scalable and consistently performant organization-wide. Reporting to the VP, Clinical Operations, the role guides CSS Supervisors in translating priorities into actionable processes and leads continuous improvement initiatives. Candidates should bring 5+ years of leadership experience managing remote teams, with healthcare and value-based care experience preferred. Apply here.

8. Aledade is hiring a Director, Population Health Impact (Multiple locations, Remote) to steward the organization's healthcare equity commitment, partnering cross-functionally to close healthcare disparities and drive equitable clinical outcomes. The role leads data analysis, solutioning, and execution on key equity initiatives, collaborating with other leaders on processes, pilots, and partnerships for under-resourced communities. Candidates should bring 12+ years in a clinical environment, including 5+ years leading healthcare equity-focused quality and process improvement programs. Apply here.

9. ProKidney is hiring a VP, Clinical Development (Multiple locations, Remote) to provide strategic and operational leadership for global clinical development programs from IND through Phase III. The role ensures scientific rigor, GxP compliance, and effective collaboration with investigators, KOLs, CROs, and internal stakeholders. Candidates must hold an M.D. with Interventional Radiology or Interventional Nephrology advanced training and bring 10+ years of clinical practice experience. Apply here.

10. Alexion is hiring a Director, Patient Services Strategy, Rare Nephrology (Boston, MA, On-site) to set and govern patient services strategy for the Rare Nephrology franchise, sequencing roadmaps across in-line indications and future launches. The role partners across OneSource, Patient Education, Field Reimbursement, Brand Marketing, Market Access, and IT to ensure a seamless, compliant patient journey and drives performance management for execution teams. Candidates should bring 8+ years of pharmaceutical or healthcare commercial experience, with a track record aligning strategy across cross-functional groups and setting KPI targets. Apply here.

11. Novartis is hiring a Lead, Health Economics & Outcomes Research (Toronto, ON, Hybrid) to develop and execute HEOR strategies that generate evidence supporting reimbursement and market access decisions. The role designs and oversees economic and outcomes research studies, partnering with Medical, Market Access, Commercial, and Global HEOR teams to support product launches. Candidates should bring advanced HEOR experience, strong knowledge of the Canadian reimbursement landscape, and demonstrated expertise in economic modeling and health technology assessments. 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.

Share

Are you hiring? Post a role on Signals Jobs, or if you want help finding and landing your next key hire, join the Signals network or reach out to us. We believe great talent is everywhere, and that the right people in the right roles get us closer to a world without kidney disease. Thanks for being here.

— Team Signals

Three years ago, I started writing this newsletter because I couldn’t find one that covered kidney health the way I thought it deserved to be covered. To be honest, it was mostly a scratch pad to share my thoughts as a first-time founder, trying to navigate the kidney space in all its complex glory. By some stroke of timing and luck, people started reading and sharing it. So I decided to go a bit deeper into the gray areas and began asking people questions: how a policy shift at CMS changes what’s viable for a product or care model, how new therapies reach patients, and why the economics driving kidney care seem vastly disconnected from other areas.

That newsletter became something bigger than I expected. You turned it into a place to learn what’s happening in kidney health, and over time, we built more capabilities around that space: media, research, advisory work, and a jobs board to name a few. Each one exists because people needed it, or because working alongside companies and clinicians made the gap obvious. That’s how we grew from a newsletter that covered a different corner of kidney health each week into a firm called Signals Group.

Today, we're turning everything we've learned, and everyone we've met along the way, into a network built to help people and ideas succeed.

The Signals Member Network

We just launched with 130 founding members across 90 organizations. Nephrologists and frontline clinicians make up about a quarter. Industry, pharma, biotechs, manufacturers, and care delivery organizations make up another quarter. We also have dozens of founders, investors, researchers, regulators, associations, and patient advocates, all in the same room.

Learn more

Here’s the thing I’ve learned running Signals for three years: the hardest problems in kidney health do not get solved by any one of these groups alone. They get solved in the spaces between them, the conversation that doesn’t happen at a conference because the right two people never end up at the same table, the question a founder has that only a clinician on the frontlines can actually answer, the policy nuance an operator needs that a regulator understands but rarely gets to talk about.

That’s what we are building, and we’re building it for you. A place where a nephrologist can find the startup solving their patients’ biggest needs. Where a founder can find the patient voice their work requires. Where patient groups can meet the organizations who want to develop new treatments and tools to support their community, and find the clinician partners to help them do that.

We ask every founding member why they joined. Networking and peer connection tops the list, followed closely by finding industry partners and customers, connecting with patient advocacy groups, research collaboration, early detection and CKD management, value-based care, and policy and regulatory connections. In other words: everything that doesn’t fit neatly into a single conference agenda or a single publication, but matters just as much when it comes to getting solutions to patients.

As we keep shifting toward a cardio-kidney-metabolic lens on this field, having the right people within reach only becomes more important. Understanding how we get from a good idea to a paid-for, adopted, patient-facing reality takes all of us, working together, not any one group alone.

If you’ve been reading or watching Signals for a while, you already know why this matters. Now there’s a place to act on it if you’re looking to meet other readers, or advance your mission in the kidney or CKM space.

Membership is free for patients, advocates, and regulators. If you’d like access, or want to learn more about joining as an industry member, reach out to us or visit members.signalsfs.com.

Thank you for reading Signals from the start, or from wherever you joined along the way. This is just the next chapter, and I’m glad you’re here for it. And to those of you who are already founding members: thank you for saying yes early, before there was much to see. You made this possible, and we can’t wait to see where it leads.

Leave a comment

Share

Subscribe now

Top Stories

1. AHA, ACC, ASN, and ADA released the first clinical guidelines for cardio-kidney-metabolic (CKM) syndrome, formalizing a four-stage system (0-4) that ties obesity, diabetes, CKD, and cardiovascular risk together, with PREVENT risk equations and earlier eGFR/UACR testing at the center. Read more →

2. In IgA nephropathy news, Novartis's iptacopan (Fabhalta) won full FDA approval and Vera's atacicept (Trutakna) won accelerated approval, marking two major regulatory wins in the same indication within weeks of each other. See tracker →

3. CMS released the CY2027 Physician Fee Schedule July 14, which the RPA said “essentially breaks even” for nephrology. It’s worth noting proposed changes to remote monitoring, practice expenses, E/M add-ons, and comment solicitations on primary care and data collection. Read more →

Policy & Payment

• CMS’s CY2027 ESRD PPS proposed rule would raise the dialysis base rate to $299.55, about +1.1% to facilities, and includes increases to home dialysis training as well as technical changes to TDAPA payment calculations. Read more →

• NKF, alongside the American Kidney Fund, ASN, and ASPN, urged OMB to rescind its proposed rule on federal financial assistance regulations. Kidney disease research already receives just $19 per patient in federal funding, versus $423 for cancer and $2,745 for HIV/AIDS. Read more →

• CMS’s ACCESS model officially launched July 5, kicking off a 10-year shift to outcome-based payment for cardio-kidney-metabolic conditions, with nearly 200 organizations in the first cohort. Read more →

• Dexcom was selected as the first participant in FDA's new TEMPO pilot program, which will test an AI-powered glucose health program combining G7 and Stelo data for earlier prediabetes and type 2 diabetes screening. Read more →

Industry & Deals

• FDA granted accelerated approval to Vera’s atacicept (TRUTAKNA) for IgA nephropathy, the first dual BAFF/APRIL inhibitor approved for IgAN, based on a 46% reduction in proteinuria. Read more →

• Novartis’s Fabhalta received full FDA approval for IgA nephropathy (July 16), converting its 2023 accelerated approval into a traditional nod after phase 3 data showed statistically significant eGFR preservation over two years. Read more →

• Kyoto-based Rege Nephro raised ~$10.6M to advance RN-014, its lead candidate for autosomal dominant polycystic kidney disease (ADPKD), toward commercialization. Read more →

• Fresenius launched Fresenius Ventures, a €200M+ corporate VC fund targeting precision nutrition, microbiome research, and digital care. Read more →

• Fresenius Medical Care announced BEACON-US, generating real-world evidence on high-volume hemodiafiltration for US dialysis patients. Read more →

• Nipro cleared FDA for its ELISIO-HX dialyzer, bringing expanded hemodialysis (HDs) to the US. Read more →
  

Subscribe now

Research & Data

• A Nature study found frontier general-purpose LLMs outperformed specialized clinical AI tools like OpenEvidence and UpToDate Expert AI across medical knowledge, clinician alignment, and real-world clinical query benchmarks. (H/t Mark Sendak) Read more →

• JASN research from NYU Langone found that of 720,000+ patients referred for kidney transplant, only 48% started evaluation and 19% reached the waitlist. (H/t Conor Donnelly) Read more →

• A recent Nature study found an engineered IL-2 mutein (mIL-2) promotes long-term transplant tolerance in mice by selectively expanding ST2+ regulatory T cells, improving allograft survival while reducing dependence on conventional immunosuppression. (H/t Leo Riella) Read more →

• New AJKD Core Curriculum reviews reproductive health across CKD, dialysis, and transplantation, noting up to 6% of women of childbearing age are affected by CKD. (H/t Silvi Shah) Read more →

• A new review examines dialysis and transplant challenges in CKM syndrome patients, covering cardiovascular instability on hemodialysis, metabolic complications on PD, and elevated post-transplant cardiovascular risk. (H/t Amir Abdipour) Read more →

This issue is made possible by Nsight Health. An Optum matched-cohort analysis found that high-risk Medicare patients in Nsight's clinically managed Remote Patient Monitoring (RPM) and Chronic Care Management (CCM) programs saw directionally lower first-year medical spending growth than matched controls, with estimated total medical savings of roughly $2,500 to $3,000 per member per year across hypertension, diabetes, and CKD. All six economic comparisons favored Nsight. Download the Optum economic study white paper for the full findings.

See Optum study

Community

• IgA Nephropathy Foundation hosted SPARK 2026 last week, bringing the IgAN patient, caregiver, and research communities together. (H/t Bonnie Schneider) Read more →

• NKF hosted the 2nd Richard Slayman Clinical Xenotransplantation Workshop (July 16), bringing together transplant leaders, including NYU Langone's Robert Montgomery, to discuss the future of pig kidney transplants. (H/t Heather Murphy) Read more →

• HEAR-ALPORT launched, a University of Birmingham-led international project developing the first patient-reported outcome measures for Alport-related hearing loss, ahead of a global recruitment push in the coming months. (H/t Dr. Peipert) Read more →

• NKF’s KDOQI released a US commentary on the KDIGO 2024 lupus nephritis guideline, covering newer therapies including belimumab, voclosporin, and obinutuzumab. (H/t Sayna Norouzi) Read more →

• Upcoming events: GlomCon (Hawaii, this week), Rare KD Drug Development Summit (Boston, Aug 18-20), RPA Advocacy & Innovation Weekend (DC, Sep 25-26), ASN Kidney Week (Denver, Oct 21-25)

• Open roles: Chief Scientific Officer at Travere Therapeutics, Director of Population Health Impact at Aledade, Director of Clinical Support Services at Monogram Health, Nephrology MSL (Western US) at Veloxis, and Field Reimbursement Manager at Vertex. Find dozens more on Signals Jobs here.
  
  

  Share

We tracked 15 key developments during the first half of the year. Here are the signals that stood out.

The Wakely findings. Let’s start with the Kidney Care Choices (KCC) Model, the voluntary model that started in 2022 and runs through 2027. In January, CMS cut KCC’s quarterly capitation payments in half and eliminated its $15,000 transplant bonus, changes that followed CMS’s own finding of a statistically significant $304 million net loss to Medicare in PY2023. In June, Wakely, an independent actuarial firm commissioned by Accountable for Health’s Kidney Care Coalition, modeled what KCC’s PY2022-2024 results would have looked like under the new 2026 rules.1

Figure From Wakely: KCC 2026 Payment Changes Relative to Gross Savings

Subscribe now

Under the updated rules, and using Wakely’s benchmark-relative methodology, the analysis shows KCC would have generated net savings to CMS of $26 million in PY2023 and $90 million in PY2024, rather than a net cost, with savings climbing further under a full-risk scenario. For context, this analysis differs from Lewin’s earlier evaluation, which used a difference-in-differences design to compare KCC participants against a matched population. The two approaches answer related but different questions: Wakely estimates performance against CMS-set savings targets, while Lewin estimates whether the model changed spending relative to what likely would have happened without it.

Net-net: if Wakely’s analysis holds, a model CMS just made less financially attractive may be performing better than the headline numbers suggest. Wakely argues that this would not be unusual: MSSP took five years to produce net CMS savings, suggesting one- and two-year evaluations may reveal more about a model’s early learning curve than its long-term potential.2 With KCC scheduled to end in 2027, the question now is whether CMS incorporates that approach into whatever comes next.3

Meanwhile, operators are posting strong results. DaVita's Integrated Kidney Care division hit its first profitable year and invested in home health platform Elara. Kidneylink posted the largest cost reduction of any KCC participant, and Interwell Health reported high quality scores and elevated optimal dialysis start rates alongside shared savings of its own. Strive Health's model was featured in a national case study showing a 41% drop in hospitalizations and a 62% rise in home dialysis adoption. Blue Cross NC's Advanced Kidney Care program reduced health care costs by $81.5 million over four years, a sign that payers are building direct kidney VBC capabilities, not just contracting them out. The operating evidence is improving just as the financial incentive to produce those results appears to be shrinking.

Share

And the ground is shifting upstream. Earlier this month, CMS launched ACCESS, a 10-year model paying for patient outcomes rather than service volume, with two of its four tracks built for early-stage cardio-kidney-metabolic conditions (e.g. hypertension, obesity, early CKD). These conditions overlap with the populations kidney VBC operators already manage, but ACCESS is designed to intervene earlier through preventive services tied to specific clinical outcomes and markers. None of the major kidney VBC operators appear on the initial list of accepted participants. A small number of renal practices are participating, but the initial list is dominated by a different mix of organizations, including Withings, WHOOP, Noom, Berry Street, Aledade, AristaMD, Devoted, and Story Health across devices, nutrition, primary care, and chronic-care management.

The model leans heavily on technology-supported care, and the participant list reflects that. With fixed payments as low as $7.50 per patient per month, and commercial insurers pledging to align with the model by 2028, low-cost enabling technologies will need to play a central role if this type of outcomes-based payment model is to prove sustainable.

We track all of this closely. Twice a year, and after every major market move, we publish a sourced, dated log covering policy shifts, company milestones, clinical evidence, and funding activity across kidney value-based care (see below). Our mid-year update just went live, covering the items above and a dozen more.

vbc.signalsfs.com

The full sourced log, along with the dataset we maintain year-round across patient counts, managed spend, financing, leadership changes, and clinical outcomes, is available at vbc.signalsfs.com. If you see a development we missed, or are working through what these changes mean for your strategy, let us know.

Leave a comment

Share

This is a working document, and we need your help to get it right. If something’s off, out of date, or missing, tell us in the comments. Subscribe to get our updates, and become a member to download the full dataset and meet other kidney leaders shaping what comes next.

Subscribe now

Pipeline Directory

1. IgA Nephropathy (IgAN)

2. C3 Glomerulopathy / IC-MPGN

3. FSGS

4. ADPKD

5. ANCA-Associated Vasculitis (AAV)

6. APOL1-Mediated Kidney Disease (AMKD)

7. Primary Membranous Nephropathy (pMN)

8. Alport Syndrome

Visual: Tracker At a Glance

IgA Nephropathy (IgAN)

IgA nephropathy is the most common primary glomerular disease worldwide, affecting an estimated 160,000 people in the US. Five years ago it had no approved therapies; today it has six. The entries below track what's in trials or approved today, organized by stage. For the disease biology behind these mechanism classes, including some approaches already tried and unsuccessful, see the figure at the end of this section.

Approved

Tarpeyo (budesonide)

• Sponsor: Calliditas Therapeutics

• Mechanism: Targeted-release corticosteroid

• Timeline: Accelerated approval in 2021; full approval in 2023

• Notes: First approved therapy for IgAN; targeted-release formulation limits systemic steroid exposure.

Filspari (sparsentan)

• Sponsor: Travere Therapeutics

• Mechanism: Dual endothelin (ETA) and angiotensin II (AT1) receptor antagonist; one molecule, two targets

• Timeline: Accelerated approval in 2023; full approval in 2024

• Notes: Also approved in FSGS (2026).

Fabhalta (iptacopan)

• Sponsor: Novartis

• Mechanism: Oral Factor B inhibitor (alternative complement pathway)

• Timeline: Accelerated approval Aug 2024; full approval July 2026

• Notes: APPLAUSE-IgAN: showed a 48% slower eGFR decline vs. placebo over two years, the first complement inhibitor to confirm kidney-function preservation in IgAN rather than just proteinuria reduction. Also approved in C3 glomerulopathy (2025).

Vanrafia (atrasentan)

• Sponsor: Novartis

• Mechanism: Selective endothelin A receptor antagonist

• Timeline: Accelerated approval in 2025

• Study: ALIGN

Voyxact (sibeprenlimab)

• Sponsor: Otsuka

• Mechanism: Anti-APRIL monoclonal antibody

• Timeline: Accelerated approval in 2025

• Notes: Phase 3 VISIONARY two-year results (Jul 2026): statistically significant eGFR stabilization and improvement, confirmatory data already in hand.

Trutakna (atacicept)

• Sponsor: Vera Therapeutics

• Mechanism: Dual BAFF/APRIL binder

• Timeline: Accelerated approval Jul 2026

• Notes: ORIGIN 3 interim: 42% proteinuria reduction vs. placebo at 36 weeks; confirmatory eGFR data expected Q3 2026 (NCT04716231)

Phase 3

Zigakibart

• Sponsor: Novartis

• Mechanism: Anti-APRIL monoclonal antibody

• Trial: BEYOND (NCT05852938)

Telitacicept

• Sponsor: RemeGen / Vor Biopharma

• Mechanism: Dual BAFF/APRIL (TACI-Fc fusion protein)

• Status: Approved in China (NMPA, Jun 2026); not yet filed in the US (NCT05799287)

Povetacicept

• Sponsor: Vertex Pharmaceuticals

• Mechanism: Dual BAFF/APRIL (TACI-Fc fusion protein)

• Status: PDUFA Nov 30, 2026 (NCT06564142)

Felzartamab

• Sponsor: Biogen

• Mechanism: Anti-CD38 antibody (plasma cell depletion)

• Trial: PREVAIL (NCT06935357)

• Notes: The same drug is also in Phase 3 for kidney transplant rejection (TRANSCEND) and Phase 3 for pMN (PROMINENT), three kidney indications in parallel development.

Phase 2

SHR-2010

• Sponsor: Hengrui

• Mechanism: MASP-2 inhibitor (lectin complement pathway)

• Study: NCT05398510

RG002C0106

• Sponsor: Rigerna Therapeutics

• Mechanism: Undisclosed

• Study: NCT07305974

Phase 1

Mezagitamab (TAK-079)

• Sponsor: Takeda

• Mechanism: Anti-CD38 (plasma cell depletion)

• Study: NCT06963827
  

Subscribe now

C3 Glomerulopathy / IC-MPGN

C3G and primary IC-MPGN are ultra-rare kidney diseases, affecting an estimated 5,000 people in the US. Both now have an approved complement inhibitor, a remarkably mature standard of care for a disease this rare. The pipeline behind them is thin, the frontier here has largely moved to real-world use. The figure below shows where in the complement cascade these therapies intervene.

Approved

Fabhalta (iptacopan)

• Sponsor: Novartis

• Mechanism: Oral Factor B inhibitor (alternative complement pathway)

• Timeline: Approved in 2025

• Notes: Also approved in IgA nephropathy (July 2026). (NCT04817618)

Empaveli (pegcetacoplan)

• Sponsor: Biogen (via its 2026 acquisition of Apellis), partnered ex-US with Sobi

• Mechanism: C3 inhibitor

• Timeline: Approved July 2025

• Notes: Phase 3 VALIANT study showed a 68% reduction in proteinuria versus placebo, alongside stabilization of kidney function and substantial clearance of C3 deposits on biopsy. Also advancing into a pivotal FSGS trial. (NCT05809531)

Phase 2

Zaltenibart (OMS906)

• Sponsor: Omeros

• Mechanism: MASP-3 inhibitor (alternative complement pathway) (NCT05972967)

• Notes: Distinct from Omeros’s earlier MASP-2 asset narsoplimab, which did not advance in this indication.

Subscribe now

FSGS

Focal segmental glomerulosclerosis (FSGS) is a progressive glomerular disease characterized by podocyte injury, proteinuria, and risk of kidney failure. Until recently, no medicines had been approved by the FDA or European Medicines Agency, with management focused on supportive care and proteinuria reduction. Filspari changed that in April 2026. Behind it sits a genuinely varied pipeline, more mechanistic diversity than any other disease in this tracker at a comparable stage. The images below show how FSGS changes the structure of the glomerulus.

Approved

Filspari (sparsentan)

• Sponsor: Travere Therapeutics

• Mechanism: Dual endothelin (ETA) and angiotensin II (AT1) receptor antagonist, one molecule with two targets

• Timeline: Approved April 2026

• Notes: First approved in IgA nephropathy (2023). (NCT03493685)

Phase 3

DMX-200

• Sponsor: Dimerix

• Mechanism: CCR2 antagonist

• Trial: ACTION3 (NCT05183646)

Apecotrep

• Sponsor: Boehringer Ingelheim

• Mechanism: Oral TRPC6 inhibitor (podocyte-targeted)

• Trial: PODOMOUNT-FSGS

• Notes: Also in Phase 2 for Alport syndrome via the same company’s basket trial, PODOMOUNT-Basket. (NCT07220083)

Inaxaplin

• Sponsor: Vertex Pharmaceuticals

• Mechanism: APOL1-targeted small molecule

• Trial: AMPLITUDE

• Notes: The original proof-of-concept data for this drug was generated in APOL1-mediated FSGS specifically, before Vertex broadened its framing to APOL1-mediated kidney disease (AMKD) as a category. Also tracked under AMKD below with a second, earlier-stage trial (AMPLIFIED) for patients who don’t qualify for this pivotal study. (NCT05312879)

Empaveli (pegcetacoplan)

• Sponsor: Biogen (via its 2026 acquisition of Apellis)

• Mechanism: C3 inhibitor

• Notes: Approved in C3 glomerulopathy since 2025. Apellis's January 2026 earnings release confirmed pivotal FSGS trial initiation, describing FSGS as a disease with "significant complement pathway involvement and high unmet need." The same release noted a parallel pivotal trial in delayed graft function (DGF), a related post-transplant complication, reflecting a broader push to extend complement inhibition across kidney diseases. (NCT07213960)

Phase 2

Frexalimab / Brivekimig / Rilzabrutinib

• Sponsor: Sanofi

• Trial: RESULT, a basket trial testing all three candidates, each with a distinct immune-modulating mechanism, in FSGS and minimal change disease. (NCT06500702)

Share

ADPKD

Autosomal dominant polycystic kidney disease (ADPKD) is the most common form of PKD and the most common inherited kidney disorder, affecting an estimated 1 in every 400 to 1,000 people. It's caused by a mutation in the PKD1 or PKD2 gene, and typically presents between ages 30 and 50. ADPKD has had an approved therapy since 2018; the two programs now in trials aim to intervene closer to the disease's genetic cause rather than manage symptoms downstream.

Approved

Jynarque/Jinarc (tolvaptan)

• Sponsor: Otsuka

• Mechanism: Vasopressin V2 receptor antagonist

• Timeline: Approved in 2018

• Notes: Approved in 2018 based on TEMPO 3:4 and REPRISE, showing slower kidney volume growth and eGFR decline versus placebo. Still the only approved ADPKD therapy today. Carries a boxed warning for risk of serious liver injury, requiring monitoring. (NCT00428948, NCT02160145)

Phase 3

Farabursen

• Sponsor: Novartis, acquired via its 2025 purchase of Regulus Therapeutics for up to $1.7 billion

• Mechanism: Anti-miR-17 oligonucleotide

• Notes: Phase 1b data showed complete cessation of kidney volume growth. Now in a single pivotal Phase 3 trial. (NCT05429073)

Phase 2

VX-407

• Sponsor: Vertex Pharmaceuticals

• Mechanism: PC1 (polycystin-1) corrector

• Trial: AGLOW

• Notes: Tries to correct the underlying protein defect directly, rather than managing downstream cyst growth. (NCT07161037)

ANCA-Associated Vasculitis (AAV)

AAV already has an approved complement inhibitor, avacopan, cleared in 2021, though the FDA proposed withdrawing that approval in April 2026 over a serious liver injury signal; the drug remains on the market. Two early-stage programs are testing different approaches behind it: one targeting complement further upstream, the other targeting B cells directly.

Approved

Tavneos (avacopan)

• Sponsor: Amgen, via its 2022 acquisition of ChemoCentryx

• Mechanism: C5a receptor antagonist (complement pathway)

• Timeline: Approved in 2021

• Age: Adults only; a pediatric Phase 3 trial (ages 6–17) is ongoing, estimated completion 2028

• Notes: FDA proposed withdrawing Tavneos’s approval in April 2026, citing a serious liver injury signal and disputed elements of the original application. Amgen is contesting the decision; the drug remains on the market pending a ruling. (NCT02222155)

Phase 2

Povetacicept

• Sponsor: Vertex Pharmaceuticals

• Mechanism: Dual BAFF/APRIL (TACI-Fc fusion protein)

• Trial: RUBY-3, Phase 1b/2a

• Notes: The same molecule is in Phase 3 for IgA nephropathy and Phase 2b/3 for primary membranous nephropathy, three separate diseases in active trials simultaneously. (NCT06564142)

NM8074

• Sponsor: NovelMed Therapeutics

• Mechanism: Complement inhibitor

• Notes: Phase 2, not yet recruiting. (NCT06226662)

APOL1-Mediated Kidney Disease (AMKD)

AMKD is a genetic risk category, not a single diagnosis: two copies of a high-risk APOL1 variant, most common in people of West African ancestry, raise the risk of kidney disease and can produce several different clinical pictures, including FSGS. Three companies are developing distinct approaches to blocking the APOL1 protein. The figure below shows how these risk variants are inherited.

Phase 3

Inaxaplin

• Sponsor: Vertex Pharmaceuticals

• Mechanism: APOL1-targeted small molecule

• Trial: AMPLITUDE

• Notes: Also tracked under FSGS above, where its original proof-of-concept data was generated. (NCT05312879)

Phase 2

AZD2373

• Sponsor: AstraZeneca

• Mechanism: APOL1 inhibitor

• Study: APPRECIATE (NCT06824987)

MZE829

• Sponsor: Maze Therapeutics

• Mechanism: APOL1 inhibitor

• Study: NCT06830629

Inaxaplin

• Sponsor: Vertex Pharmaceuticals

• Mechanism: APOL1-targeted small molecule

• Study: AMPLIFIED, Phase 2b

• Notes: Open-label study for patients with diabetes or other comorbidities who don’t qualify for the AMPLITUDE pivotal trial. Same drug, same target, different population. (NCT06794996)

Subscribe now

Primary Membranous Nephropathy (pMN)

pMN has no approved therapy yet, but is closer than any other disease in this tracker without one: obinutuzumab's Phase 3 met its endpoint in February 2026 and is now under FDA Priority Review. Most of the programs behind it share a similar strategy, depleting or blocking the B cells that drive the disease.

Phase 3

Obinutuzumab

• Sponsor: Genentech/Roche

• Mechanism: Anti-CD20 monoclonal antibody (B-cell depletion)

• Notes: Phase 3 MAJESTY trial met its primary endpoint in February 2026. Granted FDA Priority Review in mid-July 2026, with a PDUFA date of November 2026. (NCT04629248)

Felzartamab

• Sponsor: Biogen

• Mechanism: Anti-CD38 antibody (plasma cell depletion)

• Trial: PROMINENT (NCT06962800)

• Notes: The same drug is also in Phase 3 for kidney transplant rejection (TRANSCEND) and Phase 3 for IgA nephropathy (PREVAIL), three kidney indications in parallel development.

Povetacicept

• Sponsor: Vertex Pharmaceuticals

• Mechanism: Dual BAFF/APRIL (TACI-Fc fusion protein)

• Trial: OLYMPUS, Phase 2b/3 (NCT07204275)

• Notes: Also in Phase 3 for IgA nephropathy and Phase 2 for ANCA-associated vasculitis.

B007

• Sponsor: Shanghai Jiaolian

• Mechanism: Anti-CD20 monoclonal antibody (B-cell depletion)

• Timeline: Phase 2/3, China (NCT06470191)

MIL62

• Sponsor: Beijing Mabworks

• Mechanism: Anti-CD20 monoclonal antibody (B-cell depletion)

• Timeline: Phase 3, China (NCT05862233)

Phase 2

SHR-2173

• Sponsor: Hengrui

• Mechanism: Not yet disclosed

• Timeline: Phase 2, China (NCT07354932)
  

  Subscribe now

Alport Syndrome

Alport syndrome is the only disease in this tracker with nothing beyond Phase 2, no approved therapy, and no active Phase 3 program today. That may not last: Vonafexor's January 2026 topline data reversed a historical eGFR decline in Alport patients, and Enyo Pharma has said it plans to move into Phase 3 in the second half of this year. The six programs below represent a fresh set of approaches to a disease that has seen real setbacks in the past.

Phase 2

Vonafexor

• Sponsor: Enyo Pharma

• Mechanism: FXR agonist

• Trial: Alpestria-1, completed

• Notes: Topline data reported a mean functional eGFR gain of +4.8 mL/min/1.73m² during treatment, reversing a historical decline of -6.4 mL/min/1.73m²/yr in the same patients, with 73% maintaining reduced albuminuria three months after stopping treatment. End-of-Phase 2 meetings planned for Q3 2026, with Phase 3 initiation targeted for the second half of the year. (NCT06425055)

Setanaxib

• Sponsor: Calliditas Therapeutics

• Mechanism: Dual NOX1/NOX4 inhibitor, one molecule blocking two related oxidase isoforms

• Timeline: Phase 2a, completed June 2025 (NCT06274489)

Exaluren (ELX-02)

• Sponsor: Eloxx Pharmaceuticals

• Mechanism: Nonsense mutation readthrough therapy

• Trial: EXACT, Phase 2b starting 2026 (NCT07523581)

Apecotrep

• Sponsor: Boehringer Ingelheim

• Mechanism: Oral TRPC6 inhibitor (podocyte-targeted)

• Trial: PODOMOUNT-Basket (NCT07355296)

• Notes: Also in Phase 3 for FSGS under the same company’s PODOMOUNT-FSGS trial.

R3R01

• Sponsor: River3 Renal

• Mechanism: ABCA1 stimulant (restores cholesterol efflux in podocytes)

• Timeline: Phase 2, completed (NCT05267262)

BAY3401016

• Sponsor: Bayer

• Mechanism: Not yet disclosed

• Timeline: Phase 2a (NCT07211685)

Closing

Thanks for reading Signals. This tracker only gets better with your help, so if something's off, out of date, or missing, please leave a comment below. This tracker continues to evolve with the field. Whether you're researching, running trials, or just trying to keep up with this space, we're glad you're here.

Leave a comment

Share

But the work does not end after surgery. After transplant, patients and care teams enter a long period of surveillance. Labs, clinic visits, medication changes, infection monitoring, antibody testing, and sometimes biopsies all become part of the rhythm of life with a transplanted kidney. The goal is simple, but difficult: catch problems early enough to protect the graft.

One of the hardest problems we have yet to solve is antibody-mediated rejection, or AMR. AMR occurs when the recipient’s immune system attacks the transplanted kidney, often involving donor-specific antibodies and inflammation in the kidney’s small blood vessels. It has emerged as a leading cause of late kidney allograft loss, and treatment has historically been limited, heterogeneous, and difficult to standardize.1

That reality sits at the center of this conversation. The future of transplant is not only about getting more people transplanted, it is also about helping every donated kidney last as long as possible.

Participants

• Matthew Cooper, abdominal transplant surgeon, Chief of Transplantation and Director of the Solid Organ Transplant Line at the Medical College of Wisconsin

• Mary Baliker, four-time kidney transplant recipient, public health professional, and longtime advocate for patient-centered transplant care

• Uptal Patel, adult and pediatric nephrologist, former transplant nephrologist at Duke, and head of Biogen’s West Coast Hub focused on kidney disease and transplant innovation
  

  Share

What’s inside

• How post-transplant monitoring works today

• Why kidney rejection can be difficult to detect before damage occurs

• What AMR is and why it matters for long-term graft survival

• How patients experience the lifelong burden of vigilance

• The role of biomarkers, biopsies, and donor-derived cell-free DNA

• Why new therapeutic innovation may change the urgency of early detection

• Biogen’s role in advancing felzartamab to Phase 3 trials for late AMR

• What a more proactive post-transplant model of care could look like

Q&A

How does post-transplant monitoring work today?

Matt: There are standards that all transplant programs follow, but there are also nuances based on training, experience, and the complexity of the patient. Follow-up is much more concentrated early after surgery, then becomes less frequent as patients move further out from transplant. But the desire is always to be proactive rather than reactive.

We are all fond of the kidney because it does so many amazing things, but it often does not give us clinical symptoms when something is wrong. We tell patients, “Let us do the busy work of assuring that everything that feels good and natural continues to look good when we do labs and other investigations.” In our clinic, patients usually come back twice a week for the first couple of weeks. They have blood work drawn, urine samples checked, and we look at markers of kidney health. We also monitor for signs of over-immunosuppression, including BK virus and cytomegalovirus, or CMV.2

We also think about the patient’s risk for rejection, whether cellular rejection or antibody-mediated rejection, and we check donor-specific antibodies at particular time points based on our protocol. Donor-specific antibodies, or DSAs, are antibodies that a recipient may develop against the donor organ and are an important risk factor for AMR and graft loss.3

All of this happens with surgeons, nephrologists, coordinators, and the rest of the transplant team. It is spelled out in the medical record and in the documentation we give patients when they leave the hospital because we want them to understand why we are doing all of these things. We also want them to know this has to be a partnership going forward.

Share

Mary, what was monitoring like from your side?

Mary: My post-transplant monitoring was very rigorous. There was intense surveillance at the beginning, and then it moved into long-term maintenance. At home, I tracked my temperature to check for signs of infection. I checked my blood pressure to watch for medication side effects. I tracked my weight to see if I was retaining fluid.

Then there was the lab work. Early on, I was having labs drawn multiple times a month. Over time, that shifted to monthly. Clinic visits were frequent at first too. I always describe it as having all eyes on me, making sure everything was together. And it really was multidisciplinary. I had the transplant surgeon, transplant nephrologist, pharmacist, transplant coordinator, and dietitian. That monitoring was such an important part of care.

Why is there so much variability across transplant centers?

Uptal: First off, transplant care is incredibly complex. The medical and surgical management is complex, and the tools available to us have been evolving. But there is also incredible variability because we do not always have high-grade evidence for best practices. We have options. We have clinicians who trained in different programs and learned different ways of doing things. Outcomes are not always dramatically different, so people can get stuck doing things the way they have been done around them.

That variability shows up at the system level too. Despite efforts to standardize care through quality oversight, data remain fragmented across health systems. Patients receive care in different parts of the healthcare system, and every transplant center has to deal with that. It also shows up in biomarker use. When we look across centers and try to identify patients, including for clinical trials, we see tremendous variation in which biomarkers are used and how frequently they are used. Variation by itself is not always a problem. But if we are not identifying patients who are developing complications from transplantation, then it is worth reexamining how we can organize ourselves better.

Why is rejection so hard to detect early?

Matt: The immune system is something we continue to learn about all the time. Every time we think we have figured it out, we realize each person responds a little differently to a kidney transplant. The immune system continues to evolve and adapt. As providers, if we are trying to be proactive rather than reactive, we are constantly looking for tools that help us get further upstream in the pathology of rejection.

We have valuable tools now, including biomarkers. But traditional tools like serum creatinine and urine protein are nonspecific and not very sensitive. By the time we see changes, we may already be behind the eight ball. We used to biopsy patients all the time. We had a biopsy protocol where every patient, depending on risk, might receive a biopsy at one month, three months, and one year. As a surgeon, I always say that if you have not seen complications from biopsies, you have not done enough of them.

So we began using tools like cell-free DNA, gene expression profiling, and molecular microscope approaches. We moved away from protocol biopsies as the only standard and started using technology to be better purveyors of biopsies. We biopsy less, but with better indications. That said, we still need better technology and better tools to identify rejection earlier.

Subscribe now

Uptal: The deeper breakdown is the failure to identify immune attacks before irreversible organ damage has occurred. The delay happens because standard monitoring usually falls back on kidney function. But kidney function lags behind the immune injury. There is a period between the time there is enough immune signal to warrant action and the time visible damage has occurred.

That is where evolving tools may help us make more informed decisions about how and when to use biopsies. Biopsy has been the gold standard for a long time, and it remains important. But complications are real. Donor-derived cell-free DNA, or dd-cfDNA, is one example of a noninvasive blood-based biomarker that can signal injury from the transplanted organ, although it does not tell you the cause of that injury by itself.4 Then, once we get into tissue, newer tools like gene expression profiling can complement what we see under the microscope and give us a more refined understanding of immune activity.

Mary, what is it like to live with that uncertainty?

Mary: As a transplant recipient, I feel like I live in this dual state of reality. There is deep gratitude for the gift of life and the second chance at life. But it is paired with a chronic fear that the gift could disappear at any time, at any moment. I know that better than most, having had four kidney transplants. You never lose that fear. I am 27 years out with my fourth transplant, and I know there is still a chance something could happen.

When did you become an activated patient?

Mary: My story may be a little different because I was diagnosed with kidney disease when I was nine years old, and I had my first transplant as a teenager. I became an activated patient with my first transplant. Part of that was because my transplant surgeon said to me, “You know your body better than anyone else.”

That was life-changing. It validated me. It shifted me from being a passive recipient of medical care to being the captain of my healthcare. My early training was learning the visual appearance of my pills, memorizing the signs of rejection, and really owning my care. I think that should be the gold standard for patients.

What should patients ask their care team?

Mary: Patients should see themselves as part of the team. Shared decision-making is important. What are your goals? What do you want from this transplant? What kind of life are you trying to get back to? For me, transplant gave me the opportunity to go to college, which I never thought I would see because I honestly did not think I would live long enough.

Patients should also ask about monitoring. Other than biopsy, what else can we do that is less invasive? What is happening in the field? What tools are available? If you have questions, go to your providers and talk to them. You should feel educated on what you need to know to have the best quality of life possible.

Share

How do you think about shared decision-making?

Matt: The important point is that asking questions is a good thing. I never fear when someone asks questions because it tells me they recognize both the responsibility and the partnership we are engaging in. We try to create that partnership well before surgery. We often have months before a transplant, especially with living donor transplants, so we work to build collaboration ahead of time.

I love what Mary said because we ask the same kind of question: What does transplant mean to you? What are you looking forward to after transplant? Everyone has a different answer. Everyone’s story is a little different. But we want to help them meet that expectation. At the same time, we are not with patients 24/7. We need them to take medications, come to appointments, and get labs drawn. The challenge is that the further people get from transplant, the less frequently we see them. If patients are the captains of their health and are comfortable connecting with us when something is out of the ordinary, the relationship becomes much more seamless.

What would a more proactive model look like?

Uptal: We started with variability, and that variability exists at the system level, provider level, and patient level. Part of moving forward is recognizing the value of early detection. Another part is the availability of new treatments, because new treatments increase attention to early detection.

We have seen that in IgA nephropathy, a relatively common glomerular disease. As disease-modifying treatments become available, practice patterns change. Clinicians act on tests differently. They test more thoroughly. They recognize the disease earlier. Something similar could happen in transplantation if the treatment landscape evolves.

At the system level, centers need access to the right tools, whether locally or externally. At the provider level, there needs to be awareness and comfort with those tools. Then, at the patient level, monitoring should be personalized. Several years after transplantation, one patient may want a different level of noninvasive monitoring than another patient. The point is to use the tools we have to create more informed discussions with patients.

Where do you see the field moving?

Matt: One challenge in becoming more proactive is that even if we identify AMR, we have not historically had great tools to treat it. In some respects, I think the field became a little apathetic. Maybe that is not the best word, but it is real. Over the course of my 25 years, we investigated a number of interventions that did not achieve our goals.

Now it is incredibly exciting to see what is coming. I just spent several days at the American Transplant Congress, where a lot of this science was coming forward. Some of the opportunities we are seeing have re-engaged our interest in early identification because we may now have something to treat people with.

We also have to recognize that our clinics are already full. A lot of this will need to happen in the outpatient setting. There is enthusiasm around urine-based biomarkers that patients could potentially use at home. That would be exciting. But we still need to explain to patients why ongoing monitoring matters. Why do we still want labs monthly when someone is six, seven, or eight years out? Because we want to stay ahead of this. I do not think we should completely get away from biopsies. Biopsy is still the gold standard. But better biomarkers could help us know when a biopsy makes sense.

Mary, what is your reaction to a more proactive model?

Mary: To me, it is exciting. A proactive model shifts the focus from reactive crisis management, where we fix problems after they happen, to anticipatory and integrated care. It is about preventing clinical and systematic failures before they occur. It also validates the patient experience. Instead of forcing patients to fight the system to be heard, the model honors what patients know about their bodies.

Patient self-tracking, physical intuition, and clinical evidence all matter. What patients are saying is not an annoyance. We are bringing something to the table. I think about my own history with antibody-mediated rejection. What could we have done differently? Was there something we could have caught earlier so I would not have lost my third transplant?

There is also a mental burden. Patients often feel like they have to be the project manager, pharmacist, insurer, and everything else. A more proactive system could take some of that weight off patients and allow us to spend more energy living life, not just keeping the kidney alive.

Share

Why did Biogen invest in transplant?

Uptal: It is an interesting story, and it began before my time. The people who deserve the highest credit are Dr. Georg Böhmig at the Medical University of Vienna and Dr. Klemens Budde at Charité University in Berlin. They had the insight that targeted anti-CD38 therapies could be very effective in treating AMR.5

The dominant paradigm at the time was that donor-specific antibodies were the central driver of this disease process. AMR accounts for much of the late allograft loss we see in transplantation. Acute rejection rates have improved dramatically over the past 30 to 40 years, but we have not made a real dent in long-term graft survival. That is likely related to chronic allograft rejection, much of which we recognize as antibody-mediated.

Drs. Böhmig and Budde approached companies that had anti-CD38 therapies and found a small German company called MorphoSys. MorphoSys developed felzartamab, a monoclonal antibody targeting CD38 that was developed specifically for immune-mediated diseases. Anti-CD38 therapies are commonly used in oncology for multiple myeloma, but clinicians have also used these therapies off-label in difficult autoimmune diseases.

In the transplant setting, there was a case where a patient who had been treated with an anti-CD38 therapy for myeloma later underwent a kidney transplant, developed rejection, and the rejection resolved with therapy. That observation helped motivate the proof-of-concept study. MorphoSys supported the study. I later joined a company that licensed felzartamab from MorphoSys. We completed the study and worked closely with the investigators to read out the results.

The proof-of-concept study showed a level of AMR resolution that had not been seen before. Roughly 80% of participants in the small Phase 2 study had resolution of AMR compared with about 20% in the placebo group.6 Two-thirds had microvascular inflammation scores down to zero, which had not been seen with other therapies. Microvascular inflammation means inflammation in the tiny blood vessels of the transplanted kidney and is a key histologic feature of AMR.7

What we have learned since is that the biology is more complicated than antibodies alone. Natural killer cells, or NK cells, appear to play a large role too. CD38 is expressed on antibody-producing cells and on NK cells. By modulating or depleting these cells, we saw near reversal of disease activity in molecular tests on tissue samples before and after treatment.

It was a small proof-of-concept study, but other markers were consistent. Molecular activity scores improved. Donor-derived cell-free DNA went to very low levels, suggesting there was no longer active tissue injury. Kidney function stabilized. If this bears out in the Phase 3 study now underway, it could represent a transformative treatment for patients with AMR.8

Subscribe now

What does this mean for the field?

Matt: I love hearing stories that begin with someone being uncomfortable with the status quo. That has always driven me in transplant. We are constantly saying we have to do better.

The story Uptal presented started with two physicians who were struggling with AMR and said, “I have an idea. Let’s cooperate with industry and figure out how to make this happen.” The results published in the New England Journal of Medicine from the Phase 2 experience are remarkable and something we should all be excited about.

The reason we need to keep innovating is that until we have an unlimited supply of organs, or we identify a mechanism of tolerance, we have to partner with patients and donor families to increase the lifespan of every graft. For a long time, we could identify AMR and give therapies that might keep it at bay, but they were not durable. They did not leave either the patient or provider feeling rewarded in the effort. Now we may be in a place where we have a potential therapy, and that makes us look more aggressively at early identification.

Mary, why does innovation matter so much for patients?

Mary: Innovation is key. I have had four transplants, and my first was in 1980. That was really the beginning of transplant in many ways. There was not a lot out there. If you had rejection, they threw everything and the kitchen sink at you. They thought something might work, but they did not always know.

For me, financial investment and clinical innovation are not just about survival, freedom, or a normal life. They can be a life-saving miracle. I was rare disease until this past year. When I was diagnosed, my parents were told I had six months to live because they did not dialyze or transplant kids at that point. The reason I am here is innovation. Transplant is here because of innovation. And when we find these problems, we need treatments.

Any final thoughts?

Matt: I want patients to know that the success of transplant is cooperation and partnership. That includes providers, patients, and the tools and technologies we use to ensure the health and longevity of the graft. Communication is key. We all want the same thing. If patients are the captains of their health, let’s grab onto that. If something is out of the ordinary, or if they have a question, they should know there is never a closed sign on the transplant program.

Uptal: I share Matt’s enthusiasm. I am excited about the innovation happening in transplantation and the stronger partnerships across patients, systems, providers, and industry. There is a huge opportunity to maximize the gift of life. I am inspired by people like Dr. Cooper and certainly by Mary, who is a true kidney champion.

Mary: The work that both of you do makes it possible for patients like me to be here. People ask me, “You have had four transplants?” And I always say: transplant works. It has given me a quality of life I never thought I would have. Being sick as a child, until my first transplant, I did not remember what it felt like to feel good.

Transplant gave me everything. It gave me the opportunity to go to school, have a career, get married, and grow old, which I never thought would happen. We need to keep the innovation going so people can keep their kidneys longer and say they have had their transplant 27 years or more, like me. Maybe it took four times to get there, but to me they were all successful.

###

If you're working on early detection, monitoring, or treatment in transplant, we'd love to hear what you're seeing. Leave a comment or pass this along to someone who should see it.

Leave a comment

Share

If you missed it, we also published three pieces worth your time this month: Lisa Bonebrake of the Alport Syndrome Foundation on genetic testing and the push toward approved treatments, Janis Naeve and I on why kidney care became the proving ground for healthcare’s trillion dollar accountability transition, and a guest essay from Kidney Research UK’s Gaia Cantelli on why breakthroughs need shared infrastructure. We also shared our conversation with Dallas Renal Group, Michigan Kidney, and Confido Health on what it actually takes to move AI from pilot into patient-facing workflows.

As always, thanks for being here and for sharing these updates with your networks.1

Subscribe now

What’s Inside

• News: BK virus M&A, $1.9B for RNA editing, Travere’s BTK deal, Vera gets accelerated approval, Amgen recall, pediatric CRRT, Aetna VBC expansion, kidney disease education and PKD Cures Act

• Research: Finerenone across the CKD spectrum, CAR T-cell desensitization, Eledon’s long-term Phase 2 data, Renalytix two-year RWE, HDF mortality, PKD pathway discovery, APOL1 in living donors, first-ever CKM guidelines

• Community: FIND-CKD reflections from Glasgow, NKF leadership transition, immunosuppression tolerability, patient-built navigation tools, ANNA’s new micro-credential programs

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

• Jobs: Strive, Monogram, NIPRO, Otsuka, Travere, DaVita, Biogen, Aledade, Siemens, Mozarc + dozens more on jobs.signalsfs.com
  
  

  See open roles

This issue is made possible by Nsight Health. An Optum matched-cohort analysis found that high-risk Medicare patients in Nsight's clinically managed Remote Patient Monitoring (RPM) and Chronic Care Management (CCM) programs saw directionally lower first-year medical spending growth than matched controls, with estimated total medical savings of roughly $2,500 to $3,000 per member per year across hypertension, diabetes, and CKD. All six economic comparisons favored Nsight. Download the Nsight-Optum Economic Study White Paper for the full findings.

View White Paper

News

• Ascidian Therapeutics and Eli Lilly have signed a research collaboration worth up to $1.9 billion to develop RNA exon editing therapies for genetic kidney diseases. Unlike traditional gene editing, Ascidian's platform edits RNA rather than DNA, excising disease-causing exons and replacing them with healthy ones without altering the genome itself. Ascidian will lead discovery while Lilly takes on preclinical and clinical development, pairing Ascidian's editing platform with Lilly's renal disease expertise and commercial infrastructure. (H/t Will Maddox)

• Ipsen has agreed to acquire Memo Therapeutics for up to 700 million EUR, adding potravitug, a first-in-class monoclonal antibody targeting BK virus, to its rare disease pipeline. BK virus is a serious and common complication in kidney transplant recipients that can lead to graft loss, yet has no approved targeted treatment. Phase II data showed potravitug meaningfully reduced biopsy-proven disease by week 20 with a clean safety profile, and the SAFE KIDNEY III trial is planned for later this year. (H/t Kevin Fowler)

• Travere Therapeutics has licensed civorebrutinib, an oral BTK inhibitor, from Everest Medicines in a deal worth up to $1.14 billion, adding a potential pipeline-in-a-product to its rare kidney disease portfolio. The $112.5 million upfront payment gives Travere exclusive global rights outside China and parts of East and Southeast Asia, with initial development focused on primary membranous nephropathy, where proof-of-concept data already exist, followed by FSGS and minimal change disease.

• The FDA granted accelerated approval to TRUTAKNA (atacicept), making it the first therapy to target both BAFF and APRIL in adults with primary IgA nephropathy, based on a 46% reduction in proteinuria from baseline and a 42% reduction versus placebo at 36 weeks in the ORIGIN 3 trial. The self-administered weekly subcutaneous injection addresses the immunological drivers of IgAN at the source, with approximately 160,000 U.S. patients estimated to be affected. Full approval remains contingent on eGFR results from the ongoing ORIGIN 3 trial, expected in Q3 2026.

Signals Download: Rare KD Landscape

• The FDA has again declined to approve Unicycive's drug for hyper-phosphatemia in dialysis patients, citing manufacturing deficiencies at a third-party facility for the second consecutive year. The company said the complete response letter raised no new concerns about the drug's safety or efficacy, and Unicycive contends the FDA did not inspect the manufacturing site during its review of the resubmitted application. Analysts at Piper Sandler characterized the setback as a manufacturing hurdle rather than a clinical one, and continue to see a path to approval.

• Amgen has voluntarily recalled nearly 944,000 bottles of two prescription medications due to foreign substance contamination and manufacturing deviations, including Sensipar (cinacalcet), commonly used to manage secondary hyperparathyroidism in CKD and dialysis patients, and Corlanor (ivabradine), used to treat heart failure. Affected lots include 30 mg Sensipar tablets with expiration dates through late 2028. Patients and providers can check affected lot numbers via the FDA enforcement report.

• CareDx has completed the sale of its Lab Products business to Eurobio Scientific for $171.2 million, shedding its global IVD kit portfolio to sharpen focus on U.S. precision medicine testing services and patient and digital solutions. The divested business includes HLA typing and NGS-based monitoring assay kits for solid organ and stem cell transplant recipients outside North America.

• Xeltis has surpassed 50% enrollment in its U.S. pivotal trial for aXess, a bioabsorbable vascular access implant designed to transform into a living vessel for hemodialysis, across 20 sites with a target of 140 patients. The device holds FDA Breakthrough Device Designation, and 12-month EU data showed secondary patency comparable to matured fistulas with lower reintervention rates and stronger infection resistance than conventional grafts.

• Mozarc Medical has launched the Amecath pediatric short-term catheter, a hemodialysis-validated vascular access solution designed specifically for neonates, addressing a longstanding gap in NICU-based continuous renal replacement therapy. The catheter is engineered for small anatomy and validated for CRRT workflows. Paired with Mozarc's existing Carpediem system, it completes a dedicated pediatric CRRT pathway for the smallest patients.

• Nephrodite's Holly implantable continuous dialysis system has been accepted into the FDA's Total Product Lifecycle Advisory Program (TAP), making it one of a select group of companies to hold both Breakthrough Device Designation and TAP acceptance. The program provides structured, ongoing engagement with FDA experts to accelerate clinical and regulatory planning, and Nephrodite is now preparing for GLP studies as a precursor to first-in-human trials. (H/t Nikhil Shah)

CARE DELIVERY

• Monogram Health has expanded its partnership with Aetna Medicare Advantage into West Virginia, bringing in-home, multispecialty care to eligible members managing CKD, diabetes, heart failure, hypertension, and other chronic conditions. The program now covers more than 53,000 attributed patients across six states, with further expansion planned. West Virginia’s shortage of healthcare professionals makes it a notable target for this model of care delivery. (H/t Bill Frist)

• Strive Health has named two senior executives as it scales its model nationwide. Jamie Sharp, M.D., joins as Chief Medical Officer, bringing experience from value-based organizations including Rippl, Aetna, and Evolent Health, with a focus on holistic care for patients managing kidney disease alongside diabetes, heart disease, and hypertension. Chris Rigg takes the CFO role, most recently from Elevance Health, where he oversaw financial strategy for a commercial health plan serving over 32 million members. (H/t Kendall Rejent)

• Istios Health has partnered with Americare Kidney Institute to embed clinical research infrastructure into the 15-location Northeast Ohio nephrology practice and expand virtual nephrology coverage for hospitals facing specialist shortages. Istios will handle study operations, regulatory coordination, and sponsor engagement, allowing Americare physicians to participate in cardiorenal-metabolic trials without disrupting patient care.

POLICY & REGULATORY

• CMS's ACCESS payment model launched July 5th, enrolling more than 150 healthcare organizations in a pilot that pays providers based on measurable patient outcomes rather than services rendered, with fixed payments as low as $7.50 per patient per month. The model targets chronic conditions including hypertension, heart disease, and diabetes, and is widely seen as a test of whether tech-heavy, AI-enabled care delivery can generate enough value at low reimbursement rates to be sustainable. Commercial insurers have pledged to align outcomes-based payments with ACCESS by 2028, potentially extending the experiment well beyond Medicare. (H/t Axios)

• Reps. Suzan DelBene and John Joyce have introduced bipartisan legislation to expand Medicare's kidney disease education benefit beyond its current Stage 4 CKD threshold to reach patients earlier, including those at risk due to diabetes or hypertension. The Kidney Disease Education Access Expansion Act addresses a striking gap: 37 million Americans have CKD, but 87% are unaware. The bill has broad support from across the kidney community, including ASN, NKF, AKF, and more than a dozen other organizations. (H/t Rep. Suzan DelBene)

• The PKD Cures Act, the first federal legislation ever introduced specifically targeting polycystic kidney disease, was introduced by a bipartisan group of four House members in early June. The bill directs NIH to expand and intensify PKD research across basic, translational, and clinical science, and establishes a dedicated working group to develop a comprehensive research roadmap. PKD affects more than 500,000 Americans, frequently causing kidney failure and impacting multiple generations within families. (H/t PKD Foundation)

• NIH's All of Us Research Program has released data from more than 747,000 participants, making it the world's largest integrated genomics and electronic health record database. The latest release includes over 535,000 whole genome sequences, 1.3 billion genetic variants, and for the first time, proteomics and RNA sequencing data, with more multiomics releases planned. Notably, 86% of participants come from communities historically under-represented in biomedical research, strengthening the dataset's value for studying conditions like CKD and cardiometabolic disease that disproportionately affect those populations. (H/t Josh Denny)

The value-based kidney care market is moving fast. Our VBC Market Intelligence covers 500+ data points across 10 leading models, tracking $40B in managed spend across 1.5M patients. Whether you're operating in the VBC space or building products for these workflows, this is your guide to who's doing what and where the market is heading.

Get access

Research

ERA Congress

• A pooled analysis of 14,574 participants across three randomized trials finds finerenone reduces kidney failure risk and cardiovascular death across a broad spectrum of CKD, regardless of disease cause, glycemic status, baseline eGFR, or albuminuria level. The INFINITY analysis, published in The Lancet, found a 24% reduction in the composite kidney outcome and meaningful reductions in heart failure hospitalization, cardiovascular death, and all-cause mortality versus placebo. Effects were consistent even among patients already on SGLT2 inhibitors, strengthening the case for finerenone as a foundational therapy layered alongside existing treatments. (H/t Brendon Neuen, Hiddo Heerspink & Vlado Perkovic)

• The FIND-CKD trial shows finerenone slows kidney function decline in non-diabetic CKD, extending the drug's proven benefits beyond its original diabetic kidney disease indication. Among 1,584 adults with CKD and albuminuria, finerenone reduced the annual eGFR decline rate from 4.0 to 3.3 mL/min/1.73 m² versus placebo, with a 23% lower risk of a composite kidney or cardiovascular outcome. The NEJM paper adds important breadth to the finerenone evidence base alongside the INFINITY pooled analysis and a companion JAMA study in glomerular disease, collectively making a strong case for finerenone across the CKD spectrum. (H/t Hiddo Heerspink)

• A Swedish cohort study of 6,174 adults validates current CKD diagnostic thresholds using directly measured GFR rather than estimates, finding that an mGFR of 60 mL/min/1.73 m² was associated with meaningfully higher rates of all-cause mortality and kidney failure compared with 90 mL/min/1.73 m². The JAMA study also found that the combined creatinine-cystatin C equation tracked most closely with measured GFR in predicting mortality, while creatinine alone underestimated risk and cystatin C alone overestimated it. The findings offer direct empirical support for the 60 mL/min threshold that underpins CKD staging. (H/t Edouard Fu & Antoine Créon)

• New research presented at the ERA Congress used UK Biobank and All of Us whole-genome sequencing data to quantify how different COL4A3 and COL4A4 variants affect risk of blood and protein in the urine, finding meaningful differences in pathogenicity between the two genes and across variant types. The findings could support more precise, variant-specific management of Alport syndrome and related type IV collagen (COL4 genes) kidney diseases as genetic testing becomes more widely available. (H/t Alport Syndrome Alliance)
  

Subscribe now

TRANSPLANTATION

• CAR T-cell therapy enabled kidney transplantation in two highly sensitized candidates who would otherwise have had few viable options, according to a Phase 1 study published in the New England Journal of Medicine. Both patients had panel-reactive antibody scores of 99.9% or higher, where conventional desensitization has largely failed. The dual CAR T-cell approach targeted CD19 and BCMA to eliminate the cellular sources of preformed anti-HLA antibodies, and Nature called the results ‘transformative.’ (H/t Yasir Qazi)

• Long-term data from Eledon's Phase 2 BESTOW trial show tegoprubart maintaining significantly better kidney function than tacrolimus at 18 months post-transplant, with a roughly 12 mL/min/1.73 m² eGFR advantage (74 vs. 61; p<0.05) and no biopsy-proven acute rejection events after the six-month mark. Patient-reported symptom burden also favored tegoprubart at 52 weeks on two validated measures. Eledon completed an FDA End-of-Phase 2 meeting and plans to initiate a Phase 3 trial in late 2026, with non-inferiority to tacrolimus on a composite of rejection, graft loss, and death as the primary endpoint.

• A new analysis from the KOAR registry links elevated donor-derived cell-free DNA levels to significantly worse three-year allograft outcomes in 1,258 kidney transplant recipients across 56 U.S. centers, published in JASN. High dd-cfDNA states were associated with 3.7- to 6.4-fold higher adjusted hazards of graft loss, and critically, most elevations occurred while eGFR remained preserved, suggesting the test can detect subclinical injury before function visibly declines.

• Daratumumab rescued graft function in all six kidney transplant recipients with recurrent FSGS who had failed standard therapy, with four achieving complete remission and two partial remission, per a case series in Transplant International. One patient who relapsed at 12 months responded to a single retreatment dose. The authors note anti-nephrin antibodies were negative across the board, suggesting other circulating factors may drive disease in some patients, and call for prospective trials. (H/t Parthenopi Avaniadi)

• Black kidney donors with high-risk APOL1 genotypes had more than twice the risk of reduced kidney function nearly two decades after donation compared to Black donors without high-risk genotypes, according to a cohort study in JAMA Internal Medicine. The study of 445 Black and 208 White donors found 15% of Black donors carried high-risk APOL1 variants, and the authors recommend routine APOL1 genotyping for all Black living donor candidates as part of the evaluation process.

• Deceased donor organ donation fell by 494 donors in 2025, the largest single-year decline in U.S. history, according to a letter in Clinical Transplantation from NYU Langone researchers analyzing OPTN data. Brain-dead donors fell 13.6% while circulatory death donors rose 11.3%, and the steepest declines were among younger donors aged 19 to 30. The authors point to a convergence of high-profile media scrutiny, increased regulatory oversight, and broader erosion of public trust in science as likely contributors. (H/t Macey Levan)

CKD & CARDIOMETABOLIC

• A nationally representative study in JACC finds that roughly half of U.S. adults with CKM syndrome are not being treated for hypertension or high cholesterol, and among those who are treated, fewer than half achieve blood pressure or glycemic targets. Gaps were most pronounced among younger adults, women, and Hispanic adults, and risk factor control was worst in those at highest cardiovascular risk. The findings, drawn from NHANES data spanning 2015 to 2023, underscore that getting patients onto therapy is only half the battle. (H/t Rishi Wadhera)

• The American Heart Association and American College of Cardiology have issued the first-ever clinical practice guideline on cardiovascular-kidney-metabolic (CKM) syndrome, published simultaneously in Circulation and JACC. The guideline introduces a four-stage framework to assess interconnected heart, kidney, and metabolic risk, with nearly 90% of U.S. adults carrying at least one CKM risk factor. Key recommendations include earlier screening using the PREVENT equations, attention to social determinants of health, and treatment with GLP-1 therapies and SGLT2 inhibitors for appropriate patients.

• Two-year real-world data from 2,470 patients across Mount Sinai and Wake Forest/Atrium Health show Renalytix’s kidneyintelX.dkd test durably shifting disease trajectories in diabetic kidney disease. High-risk patients were 10.4 times more likely to experience significant kidney decline than low-risk patients, and among those retested at one year, 29% moved into a lower risk category. In high-risk patients over two years, eGFR decline improved by 43%, UACR decreased by 23%, and HbA1c dropped by 7.6%. The study, published in Diabetes, Obesity and Metabolism, also found that patients who initiated SGLT2i or GLP-1 therapy had nearly double the odds of achieving risk reduction. (H/t Elise Wilfinger)

• UCLA researchers have found that blocking a protein called ENPP1 accelerates kidney repair and reduces scarring after injury in mice, building on prior work showing the same mechanism aids heart tissue recovery after heart attack. ENPP1, produced by injured kidneys, disrupts energy production in damaged cells and impedes regeneration. A drug called AD-NP1, already approved for Phase 1 cardiac trials, showed improved kidney function just seven days after administration in mice, and the team plans to apply for kidney trials.

• Mayo Clinic researchers have identified a previously unrecognized kidney pathway for regulating water balance after a 1940s gout drug unexpectedly slowed PKD cyst growth instead of accelerating it. The study, published in the Journal of Clinical Investigation, shows that urate acts as an intracellular signal that concentrates urine independently of vasopressin. In a small clinical trial, adding probenecid to tolvaptan reduced urine volume by roughly 30% and cut nighttime urination significantly, and the team is now working to develop more targeted therapies based on the newly described pathway. (H/t Fouad Chebib)
  

  Subscribe now

DIALYSIS

• A real-world cohort study of 18,515 incident dialysis patients finds high-volume hemodiafiltration associated with 20% lower all-cause mortality and 29% lower cardiovascular mortality compared with conventional hemodialysis. The study, which followed newly initiated patients across Fresenius NephroCare clinics over a median 15.7 months, found consistent benefits across demographic and clinical subgroups. Prior evidence for HDF's survival advantage has come largely from prevalent patients with longer dialysis exposure, making this incident-patient focus a meaningful addition to the literature. (H/t Kamyar Kalantar-Zadeh)

• A narrative review in CKJ argues the case for hemodiafiltration is settled and the field should shift from more trials to implementation, citing the CONVINCE trial's 23% all-cause mortality reduction and consistent cardiovascular benefits across meta-analyses. The review calls for formal clinical guidelines rather than consensus statements, and outlines a research agenda centered on real-world implementation, patient-reported outcomes, mechanistic understanding, and personalized HDF regimens. The authors pointedly warn that nephrology's track record of 10 to 15 year delays in translating evidence to bedside practice is a risk the HDF field cannot afford to repeat. (H/t Giovanni Strippoli)

POLICY & PAYMENT

• A coalition of major U.S. pharmacy organizations and the National Kidney Foundation is calling for a nationwide shift from the Cockcroft-Gault equation to the 2021 CKD-EPI race-free eGFR formula for medication dosing decisions. The Cockcroft-Gault equation, developed from just 249 white male participants, has known accuracy and equity limitations that modern eGFR equations address. The transition aligns with current FDA guidance and is already gaining traction across research and clinical settings, though broad implementation will require coordinated action across health systems, labs, and educators. (H/t Wendy St Peter)

• An AJKD editorial argues that dialysis facility closures are fraying a fragile lifeline for the more than 550,000 Americans dependent on in-center hemodialysis, with contraction falling hardest on rural and Medicaid-heavy facilities. The piece traces the pressures driving closures: tight Medicare FFS margins, unpredictable commercial and MA revenue, labor costs, and a dialysis population that has shifted but not grown. The authors warn that absent regulatory intervention, further consolidation favoring large publicly held providers is likely, leaving patients in rural and underserved areas with longer travel times or no local option at all. (H/t Allison Reaves, Caroline Hsu & Daniel Weiner)

Share

Community

FROM THE FIELD

• The FIND-CKD team marked a milestone week at the ERA Congress in Glasgow, where three companion analyses were published simultaneously in NEJM, JAMA, and The Lancet, collectively showing finerenone reduces kidney failure, cardiovascular events, and mortality across the full spectrum of CKD regardless of diabetes status or disease cause. Lead investigator Brendon Neuen said he hopes the data "will forever change how kidney disease is treated," while Bayer's Meike Daniela Brinker credited the years of coordinated effort across 24 countries that made it possible. (H/t Brendon Neuen & Meike Daniela Brinker)

• KidneyCure, the research arm of ASN, named 34 new grant recipients this month, joining 22 continuing grantees in a cohort representing over $4 million invested in the kidney research pipeline for 2026. Projects span CYP24A1 targeting for secondary hyperparathyroidism, immunomodulatory mechanisms in polycystic kidney disease, and cardiovascular risk after transplantation.

• The Kidney Health Initiative’s Patient and Family Partnership Council is building a tolerability framework for immunosuppression drug development, modeled on approaches from oncology and grounded in a landmark survey of over 10,000 transplant recipients. A recent workshop at the Kidney Innovation Conference surfaced the lived reality behind the data: infection risk limiting career choices, fatigue and brain fog affecting work and family life, and patients who periodically reduce their own doses to function. The effort reflects a broader push to move beyond one-size-fits-all immunosuppression toward personalized regimens that reflect individual quality-of-life priorities. (H/t Mark David Lim)

• Tufts Medicine welcomed Phillipe Abreu, MD, PhD, as Director of Transplant Robotic Surgery as its team participated in the Solid Organ Robotic Transplant Symposium at Cleveland Clinic. Abreu brings expertise across abdominal transplant surgery, robotic techniques, and transplant oncology as Tufts continues building out its robotic transplant platform. (H/t Sharon Klarman)

• Monogram Health’s Chief of Palliative Care Alan Chiu argues in Becker’s Healthcare that palliative care’s potential is stunted by its persistent association with end-of-life care, and that value-based models offer the financial environment needed for it to thrive earlier in the disease course. Chiu outlines how Monogram integrates geriatric medicine principles with palliative care frameworks for patients managing CKD, heart failure, diabetes, and other chronic conditions in the home.

• The American Nephrology Nurses Association has launched a new Microcredential Program, starting with a CKD-focused offering covering the full continuum from early detection through kidney replacement therapy and conservative management. The competency-based program awards 12 continuing education contact hours and is priced at $200 for ANNA members and $250 for nonmembers. Future microcredentials in palliative care and vascular access are planned. (H/t Bridget Wilson)

COMMUNITY VOICES

Subscribe now

• The National Kidney Foundation marked a leadership transition on July 1st, as Dr. Marc Hurlbert officially began his tenure as CEO, succeeding Kevin Longino who led the organization for 11 years. Hurlbert brings more than 25 years across research, patient advocacy, and health equity, and a personal connection to the mission as a CKD care partner for his brother. In a farewell letter, Longino reflected on a decade that saw NKF become debt-free, advance landmark legislation including the Immuno Bill and Advancing American Kidney Health Act, and build CKDintercept into a national early detection movement. He signed off simply: "¡Viva la Revolución!" (Fair winds and following seas, Kevin!)

• Elizabeth Schumacher, a kidney transplant recipient on her fourth transplant, wrote a Patient Voice essay in CJASN reflecting on what the SMART trial did and didn't capture about GLP-1 therapy. The trial reassured her that standard kidney function tests remain reliable during significant weight loss on semaglutide, but she pushes further, noting that lean mass loss is the finding clinicians and patients should sit with. Her own experience: GLP-1 plus five-days-a-week strength training post-transplant left her off blood pressure medications and stronger than before. "The trial answered the kidney-safety question," she writes. "The body-composition question is only half answered by the medication." (H/t Elizabeth Schumacher)

• Biogen is advancing a Phase 3 clinical study targeting CD38 to address antibody-mediated rejection (AMR), the leading cause of long-term kidney transplant failure affecting an estimated 23,000 U.S. transplant recipients annually. Current treatments focus on suppressing donor-specific antibodies, but emerging research implicates CD38-positive natural killer cells as an independent driver of rejection, even in patients without detectable antibodies. Targeting CD38 aims to deplete both cell types simultaneously, potentially addressing the two principal mechanisms of rejection in one approach. (H/t STAT)

• The American Kidney Fund voiced strong opposition to Medicaid work reporting requirements included in CMS's interim final rule stemming from H.R.1, warning that the requirements are administratively burdensome and could cause patients with ESRD and other serious conditions to lose coverage. AKF specifically flagged that the rule lacks adequate protections for people with complex health needs. NKF also expressed strong concerns when the bill passed the Senate last July.

• Deepti Bahel, a kidney transplant recipient and senior data engineer, built the Patient Navigator Hub, a free directory connecting kidney patients and caregivers to trusted support organizations covering financial assistance, peer support, education, and advocacy resources in one place. Deepti shared the site drew more than 700 visitors in its first four weeks. If you know of a resource that should be listed, reach out through the site. (H/t Deepti Bahel)
  

Share

Events Calendar

• Rare Kidneys on the Hill Day (July 22-23)

• GlomCon Hawaii (August 3-7, Maui)

• RPA APP Workforce Solutions Webinar (August 18, online)

• Rare & Genetic KD Drug Development Summit (August 18-20, Boston)

• RHA Annual Conference (September 23-26, Savannah)

• ASN Kidney Week (October 21-25, Denver)

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

• NephCure Support Groups (Ongoing)
  
  

  Subscribe now

Jobs

• Sr. Network Engagement Partner (Detroit, MI) — Strive Health

• Director of Sales (US) — NIPRO

• Senior MSL, Nephrology (Multiple) — Otsuka

• VP, Enterprise Effectiveness (Remote) — Travere Therapeutics

• Director, Risk Intel & Analytics (Cambridge, MA) — Biogen

• Business Strategy Associate (Remote) — DaVita

• Global Health Economics Director (Remote) — Siemens

• Senior Analyst, Provider Partnerships (TN) — Monogram

• Executive Director, Brand Marketing (Remote) — Amgen

• Manager, Transformation (Remote) — Aledade

• …plus hundreds more at jobs.signalsfs.com
  

Find your next role

Work with us

Signals Group and Bright Frontier Capital are building the connective tissue of the kidney health ecosystem. Whether you're looking to increase visibility for your work, find strategic partners, navigate and grow your business, we'd love to hear from you.

1. Learn — Hundreds of articles and interviews in our Data Room

2. Analyze — Apply our VBC research to your strategy or business

3. Sponsor — Share your mission with 15,000+ kidney leaders

4. Connect — A sneak peek at something new launching next month… =)

If something in this month’s recap sparked a thought, question, or you just want to learn more, hit reply. We read every note. Thanks for being here.

Leave a comment

Share

Your curated list of senior level, high priority roles across the kidneyverse, delivered straight to your inbox every month. This edition features senior roles across marketing, medical affairs, sales, strategy, and engineering.

Subscribe now

At A Glance

• Director, US Patient Marketing, Nephrology (Biogen)

• Executive Director, Brand Marketing & Reputation (Amgen)

• Senior Medical Science Liaison, Nephrology (Otsuka)

• Global Health Economics Director, Cancer Care (Siemens)

• Vice President, Enterprise Effectiveness (Travere)

• Senior Analyst, Provider Partnerships (Monogram Health)

• Sr. Network Engagement Partner (Strive Health)

• Business Strategy Associate (DaVita)

• Director of Sales (NIPRO)

• Director, Human Factors Engineering (Vantive)

• Manager, Transformation (Aledade)
  

  Browse all jobs

Open Roles

1. Biogen is hiring a Director, US Patient Marketing, Nephrology (hybrid, Cambridge MA) to own the patient engagement strategy for a high-visibility nephrology launch, driving patient activation, diagnosis acceleration, and long-term brand affinity across diverse kidney disease communities. The ideal candidate brings 10+ years of US commercial experience, including 5+ years in pharma or biotech marketing, with a track record in rare disease, integrated consumer marketing, and omnichannel strategy. Biogen is a global biotech with a growing nephrology portfolio targeting IgA nephropathy and other rare kidney diseases. Apply here.

2. Amgen is hiring an Executive Director, Brand Marketing & Reputation (remote, California) to lead integrated brand strategy, corporate storytelling, content operations, and reputation initiatives for one of the world’s leading biotechnology companies. The ideal candidate brings 12+ years of corporate communications or brand marketing experience, 6+ years of people management, and a track record of building scalable content and creative organizations. Amgen is a global biotech with a significant and growing presence in cardiometabolic and kidney disease. Apply here.

3. Otsuka is hiring a Senior Medical Science Liaison, Nephrology (field-based, Northeast US) to serve as a credible clinical and scientific partner to key opinion leaders, healthcare providers, and patient groups across nephrology and immunology, supporting Otsuka’s ecosystem-based engagement model. The ideal candidate brings an MD, PharmD, or PhD, 5+ years of medical affairs experience, and prior MSL or clinical experience in nephrology or immune-mediated kidney disease. Otsuka is a global pharmaceutical company with a growing rare kidney disease portfolio including treatments for IgA nephropathy. Apply here.

4. Siemens Healthineers is hiring a Global Health Economics Director, Cancer Care Value Programs (remote, Seattle) to lead global growth strategy and health economic evidence generation across radiation oncology, theranostics, and related programs, engaging payers, HTA bodies, and hospital procurement committees worldwide. The ideal candidate brings 8+ years in strategic healthcare finance or health economics, deep knowledge of US reimbursement, and a track record of building sophisticated financial models for complex oncology programs. Siemens Healthineers is a global medical technology leader advancing diagnostics, imaging, and cancer care solutions. Apply here.

5. Travere is hiring a Vice President, Enterprise Effectiveness (remote) to help the organization scale thoughtfully following multiple FDA approvals, leading enterprise transformation, organizational design, governance, and operating effectiveness across a growing rare disease portfolio. The ideal candidate brings 15+ years of leadership experience in biotech, pharma, or consulting, with a proven track record of large-scale enterprise transformation and the ability to influence and align leaders across a complex organization. Travere is a rare disease biotech with a focused kidney and metabolic disease portfolio. Apply here.

6. Monogram Health is hiring a Senior Analyst, Provider Partnerships (onsite, Brentwood TN) to support the growth and optimization of Monogram's provider network, translating data-driven insights into actionable strategies across clinical, operations, and client partnership teams. The ideal candidate brings 3+ years of experience in value-based care or healthcare operations, advanced Excel and PowerPoint skills, and exposure to provider networks or ACOs. Monogram Health is a leading multispecialty provider of in-home, evidence-based care for patients with chronic kidney disease and related conditions. Apply here.

7. Strive Health is hiring a Sr. Network Engagement Partner (hybrid, Detroit MI) to own external provider and network relationships — PCPs, nephrologists, hospitals — as Strive launches and grows in new markets, ensuring continuity of care for CKD and ESRD patients. The ideal candidate brings 8+ years of combined relevant experience and strong relationship-building skills across provider networks. Strive Health is a value-based kidney care company partnering with nephrologists to deliver comprehensive, coordinated care for patients with chronic and end-stage kidney disease. Apply here.

8. DaVita is hiring a Business Strategy Associate (remote, Denver CO) to support the development of integrated kidney care strategy and help prepare the organization for value-based care, blending strategic analysis with operational execution across clinical transformation initiatives. The ideal candidate brings 1–3 years of experience in management consulting, investment banking, or corporate strategy, with a strong interest in healthcare delivery. DaVita is one of the largest kidney care providers in the US, operating thousands of dialysis centers and integrated kidney care programs nationwide. Apply here.

9. NIPRO is hiring a Director of Sales (remote) to lead the US Renal Products commercial business, driving revenue growth, building high-performing sales teams, and shaping commercial strategy across a complex healthcare market. The ideal candidate brings 10+ years of progressive commercial experience in renal products, 5+ years leading national or regional sales teams, and deep expertise in dialysis and nephrology customer models. NIPRO is a global medical device and pharmaceutical company with a significant renal care product portfolio. Apply here.

10. Vantive is hiring a Director, Human Factors Engineering (onsite, Plymouth MN) to lead the global HFE function across user research, usability, UX design, and validation for a kidney-focused medical device company, ensuring therapy systems are safe, effective, and user-centered across the product lifecycle. The ideal candidate brings 12+ years of human factors or UX leadership in medical devices, 10+ years of people management, and a track record working with regulatory agencies. Vantive is a kidney-focused medical device company spun out of Baxter, specializing in peritoneal dialysis, hemodialysis, and acute renal therapies. Apply here.

11. Aledade is hiring a Manager, Transformation (remote) to support high-priority transformation initiatives out of the Office of the CEO, with an initial focus on scaling value-based care insights into partner practice EHR workflows across Aledade's network. The ideal candidate brings 5+ years of experience in healthcare strategy or operations consulting and hands-on familiarity with AI tools beyond basic chatbots. Aledade is one of the largest independent primary care enablement companies in the US, supporting physicians in value-based care models across thousands of practices. 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.

Share

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.

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.

Subscribe now

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?

Share

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.

###

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?

Leave a comment

Share

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.

Share

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.

Subscribe now

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.

Leave a comment

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.

Subscribe now

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.

Leave a comment

Share

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.
  

  Share

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.

Share

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.

Subscribe now

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.

Subscribe now

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.

Leave a comment

Share

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.

Subscribe now

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)
  
  

  Browse all jobs

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.

Share

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.

Subscribe now

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

Share

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?

Subscribe now

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?

Leave a comment

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

Subscribe now

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
  
  

  See open roles

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.

View White Paper

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)

The value-based kidney care market is moving fast. Our VBC Market Intelligence covers 500+ data points across 10 leading models, tracking $40B in managed spend across 1.5M patients. Whether you're operating in the VBC space or building products for these workflows, this is your guide to who's doing what and where the market is heading.

Get access

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)

Share

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.

Share

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)
  
  

  Subscribe now

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
  

Find your next role

Work with us

Signals Group and Bright Frontier Capital are building the connective tissue of the kidney health ecosystem. Whether you're looking to increase visibility for your work, find strategic partners, navigate and grow your business, we'd love to hear from you.

1. Learn — Hundreds of articles and interviews in our Data Room

2. Analyze — Apply our VBC research to your strategy or business

3. Sponsor — Share your mission with 15,000+ kidney leaders

4. Share — Tell us what you’re building and explore working together
   

If something in this month’s recap sparked a thought, question, or you just want to learn more, hit reply. We read every note. Thanks for being here.

Leave a comment

Share

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.

Subscribe now

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)
  
  

  Browse all jobs

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.

Share

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.

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

Subscribe now

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.

Share

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.

###

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

Leave a comment

Share

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.

Subscribe now

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.

Share

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

Subscribe now

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?

Leave a comment

Share

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.

Subscribe now

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.

Subscribe now

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

Share

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.

Leave a comment

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.