Trial Updates Brief
- ORIGIN 3 and Atacicept
- FINE-ONE and Finerenone
- PISCES and Fish Oil
- Setanaxib in Alport Syndrome
- MIL62 in Membranous Nephropathy
- RUBY-3 and Povetacicept
- BESTOW and Tegroprubart
- Telitacicept in IgAN
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Kidney Week 2025 Recap: 8 Trial Updates to Know in Nephrology
A curated recap of 8 impactful trial updates from the American Society of Nephrology Kidney Week 2025.
At a moment when nephrology is experiencing one of its most rapid periods of therapeutic evolution, American Society of Nephrology (ASN) Kidney Week 2025 arrived in Houston, Texas as both an opportunity for reflection of extraordinary progress and a preview of what may soon redefine care further. The past year alone has seen long-awaited FDA approvals in IgA nephropathy (IgAN) and C3 glomerulopathy, alongside expanding evidence for upstream immune-targeted strategies that are reshaping expectations for disease modification. With an anticipated regulatory decision in FSGS on the horizon in early 2026, the field is entering a new era marked by unprecedented mechanistic diversity and clinical ambition.
This year’s meeting spotlighted this momentum, highlighting advances across glomerular disease, transplant immunology, inherited kidney disorders, and cardiorenal medicine. From deeper biologic insights to maturing late-stage pipelines, Kidney Week 2025 showcased a discipline moving beyond supportive care frameworks and toward targeted interventions capable of altering long-term kidney trajectories. In this recap, we highlight 8 trial updates to know from the meeting.
Kidney Week 2025 Recap: 8 Trial Updates to Know in Nephrology
1. ORIGIN 3 Sets the Stage for Atacicept in IgA Nephropathy
Interim 36-week data from the phase 3 ORIGIN 3 trial show atacicept, a dual BAFF/APRIL inhibitor, reduced UPCR by 45.7% from baseline, yielding a 41.8-point placebo-adjusted advantage in adults with IgAN.
Secondary outcomes demonstrated strong biologic and clinical effects, including a 68.3% drop in Gd-IgA1, 81.0% hematuria resolution, and a 47.3% reduction in UACR by week 36. Safety data revealed greater rates of injection-site reactions but fewer serious adverse events than placebo (0.5% vs 5.1%) and no deaths.
Related Content: Kidney Compass: Atacicept and ORIGIN 3 at Kidney Week 2025, with Richard Lafayette, MD
2. FINE-ONE: Finerenone Proves Benefit in Type 1 Diabetes and CKD
Finerenone produced a 25% relative reduction in UACR over 6 months versus placebo in adults with type 1 diabetes and chronic kidney disease, meeting the primary endpoint of the FINE-ONE trial (LSGM ratio 0.75; 95% CI, 0.65 to 0.87; P = .0001).
Of note, 68.1% of finerenone-treated patients achieved a ≥30% UACR reduction compared with 46.6% on placebo, aligning with ADA thresholds linked to slower kidney disease progression. The safety profile, including hyperkalemia incidence, was consistent with prior finerenone programs, with no new safety signals identified across 242 participants.
Related Content: Diabetes Dialogue: FINE-ONE and Finerenone in Type 1 Diabetes at Kidney Week 2025
3. PISCES: Fish Oil Slashes Cardiovascular Event Risk in Maintenance Dialysis
In the phase 3 PISCES trial, 4 grams of n−3 polyunsaturated fatty acids (n-3 PUFA) (1.6 grams EPA, 0.8 grams DHA) daily in adults on maintenance hemodialysis reduced the rate of serious cardiovascular events to 0.31 vs 0.61 per 1000 patient-days compared with placebo (Hazard Ratio [HR], 0.57, 95% CI 0.47–0.70; P < .001). Benefits were consistent across cardiac death (HR, 0.55), MI (HR, 0.56), stroke (HR, 0.37), peripheral vascular disease requiring amputation (HR, 0.57), and first CV event or all-cause death (HR, 0.73), with similar adverse-event rates between groups. Effects were observed in both patients with and without prior cardiovascular events, and no major safety signals emerged in the 1228-person cohort.
4. Setanaxib Clears Hurdle in Phase 2 Alport Syndrome Trial
In this 24-week phase 2a trial of 20 patients with genetically confirmed Alport syndrome, setanaxib was safe and well tolerated, with adverse-event rates similar to placebo and a single unrelated serious adverse event. Setanaxib produced a 15% mean reduction in UPCR versus placebo, with 15.4% of patients achieving ≥25% reduction and 38.5% achieving ≥10% reduction despite already optimized RAASi and SGLT2 inhibitor therapy. Notably, a 27% mean UPCR reduction persisted 4 weeks after treatment discontinuation, suggesting sustained pharmacodynamic activity.
Related Content: Kidney Compass: Setanaxib, Alport Syndrome, and RaDaR Updates at Kidney Week 2025
5. MIL62 Increased Remission and Reduced Relapse in Membranous Nephropathy
MIL62, a glycoengineered type II anti-CD20 antibody, achieved greater complete remission rates than cyclosporine A in a 153-patient, 2-year randomized phase 3 trial of biopsy-proven primary membranous nephropathy (MN), with 49.4% vs 3.9% remission at week 76 (P < .0001). MIL62 also produced faster and deeper disease control, including 87.5% vs 10.5% immunologic remission and a median time to complete remission of 14.1 months, which was never reached in the cyclosporine arm.
Risks of treatment failure and relapse were significantly reduced (HR, 0.04 and 0.07, respectively), alongside improvements in eGFR and quality-of-life measures. Safety was comparable between groups with no new signals, supporting MIL62 as a strong therapeutic option for primary MN.
6. Povetacicept Data Validate APRIL/BAFF Inhibition in IgAN and pMN
In the phase 1/2 RUBY-3 trial, povetacicept, a dual BAFF/APRIL inhibitor, produced substantial 48-week proteinuria reductions in both IgAN and primary MN, including a 64% mean UPCR reduction in IgAN (with 65% achieving <0.5 g/g and 77% declines in Gd-IgA1) and an 82% UPCR reduction with 100% immunologic remission in pMN.
Hematuria resolved in 90% of IgAN patients, over half achieved clinical remission, and kidney function remained stable across cohorts. Reductions in pathogenic biomarkers (Gd-IgA1 and anti-PLA2R) were early, deep, and sustained, supporting a potential disease-modifying effect through upstream interruption of B-cell biology. Safety data suggested povetacicept was generally well tolerated, with monitored IgG reductions but no serious infections or evidence of clinically meaningful immunosuppression.
7. BESTOW: Tegoprubart Showcases Safer Prevention of Kidney Transplant Rejection Over Tacrolimus
In the phase 2 BESTOW trial of 126 kidney transplant recipients, tegoprubart achieved eGFR comparable to tacrolimus at 12 months (69 vs 66 mL/min/1.73 m²), with several subgroups, including living-related and high-KDPI donor recipients, showing numerically greater eGFR on tegoprubart.
The composite efficacy failure rate (death, graft loss, BPAR) was 22% with tegoprubart vs 17% with tacrolimus, supporting noninferiority. Tegoprubart demonstrated a more favorable safety profile, with markedly lower rates of new-onset diabetes (1 in 47 vs 1 in 6), tremor (1.6% vs 25%), delayed graft function (14.3% vs 25.0%), and fewer severe infections such as sepsis/bacteremia (4.8% vs 17.2%).
Related Content: Innovation in Transplant Immunosuppression With Tegoprubart, With John Gill, MD
8. Telitacicept Achieves Primary Endpoint in IgA Nephropathy Phase 3 Study
In a 39-week randomized, double-blind trial, telitacicept, a BLyS/APRIL-targeting fusion protein, reduced 24-hour UPCR by 58.9% versus 8.8% with placebo (P <.0001), with sustained 55% reductions at week 39. Clinically meaningful proteinuria thresholds were achieved far more frequently with telitacicept, including UPCR <0.8 g/g in 61% vs 19.5%, <0.5 g/g in 42.1% vs 7.5%, and <0.3 g/g in 24.5% vs 0.6% of patients. Kidney function remained stable, with mean eGFR essentially unchanged (−0.010 vs −0.77 mL/min/1.73 m²) and a lower risk of ≥30% eGFR decline in the telitacicept arm.
Related Content: Kidney Compass: Phase 3 Data on Telitacicept in IgA Nephropathy at ASN Kidney Week 2025
References:
Novartis. Novartis receives FDA accelerated approval for Vanrafia® (atrasentan), the first and only selective endothelin A receptor antagonist for proteinuria reduction in primary IgA nephropathy (IgAN). Novartis United States of America. Published April 2, 2025. Accessed November 22, 2025. https://www.novartis.com/us-en/news/media-releases/novartis-receives-fda-accelerated-approval-vanrafia-atrasentan-first-and-only-selective-endothelin-receptor-antagonist-proteinuria-reduction-primary-iga-nephropathy-igan.
Novartis. Novartis receives third FDA approval for oral Fabhalta® (iptacopan) – the first and only treatment approved in C3 glomerulopathy (C3G). Novartis. Published March 21, 2025. Accessed November 22, 2025. https://www.novartis.com/news/media-releases/novartis-receives-third-fda-approval-oral-fabhalta-iptacopan-first-and-only-treatment-approved-c3-glomerulopathy-c3g.
Apellis Pharmaceuticals. FDA Approves Apellis’ EMPAVELI® (pegcetacoplan) as the First C3G and Primary IC-MPGN Treatment for Patients 12 and Older | Apellis Pharmaceuticals, Inc. Apellis Pharmaceuticals, Inc. Published July 28, 2025. Accessed November 22, 2025. https://investors.apellis.com/news-releases/news-release-details/fda-approves-apellis-empavelir-pegcetacoplan-first-c3g-and.
Vera Therapeutics. Vera Therapeutics Announces Positive ORIGIN Phase 3 Data for Atacicept in IgA Nephropathy Presented at ASN Kidney Week 2025 and Published in the New England Journal of Medicine | Vera Therapeutics. Vera Therapeutics. Published November 6, 2025. Accessed November 22, 2025. https://ir.veratx.com/news-releases/news-release-details/vera-therapeutics-announces-positive-origin-phase-3-data.
Bayer. Finerenone showed statistically significant reduction of UACR in adults with chronic kidney disease associated with type 1 diabetes. Finerenone showed statistically significant reduction of UACR in adults with chronic kidney disease associated with type 1 diabetes. Published November 6, 2025. Accessed November 22, 2025. https://www.bayer.com/media/en-us/finerenone-showed-statistically-significant-reduction-of-uacr-in-adults-with-chronic-kidney-disease-associated-with-type-1-diabetes/.
Lok CE, Farkouh M, Hemmelgarn BR, et al. Fish-Oil Supplementation and Cardiovascular Events in Patients Receiving Hemodialysis. N Engl J Med. Published online November 7, 2025. doi:10.1056/NEJMoa2513032
Gale D. Safety and Preliminary Efficacy Findings from a Phase 2A Randomized, Double- Blind, Placebo-Controlled Trial of Setanaxib in Patients with Alport Syndrome. Presented at the American Society of Nephrology (ASN) Kidney Week. Houston, Texas. November 05-09, 2025.
Cui Z, Wei M, Li P, et al. Efficacy and Safety of MIL62, a Glycoengineered Type II Anti-CD20 Antibody, in Primary Membranous Nephropathy: A Phase 3, Randomized, Controlled Trial. October 2025 - Volume 36 - Issue 10S: Journal of the American Society of Nephrology. Published online October 2025. Accessed November 18, 2025. https://journals.lww.com/jasn/fulltext/2025/10001/efficacy_and_safety_of_mil62.
Tumlin JA, Yalavarthy R, Kim DK, et al. Efficacy and Safety of Povetacicept in Patients with IgAN and Primary Membranous Nephropathy (pMN) at 48 Weeks of Treatment: The RUBY-3 Study. the American Society of Nephrology (ASN) Kidney Week. Houston, Texas. November 05-09, 2025.
Eledon Pharmaceuticals. Eledon Presents Phase 2 BESTOW Trial Results for Tegoprubart for the Prevention of Rejection in Kidney Transplantation at the American Society of Nephrology’s Kidney Week 2025 Annual Meeting | Eledon Pharmaceuticals, Inc. Eledon Pharmaceuticals, Inc. Published November 6, 2025. Accessed November 22, 2025. https://ir.eledon.com/news-releases/news-release-details/eledon-presents-phase-2-bestow-trial-results-tegoprubart.
Vor Bio. Telitacicept Achieved Primary Endpoint of Reducing Proteinuria in Stage A of a Phase 3 Clinical Study for IgA Nephropathy in China | Vor Bio. Vor Bio. Published November 8, 2025. Accessed November 22, 2025. https://ir.vorbio.com/news-releases/news-release-details/telitacicept-achieved-primary-endpoint-reducing-proteinuria.
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