When American Society of Nephrology (ASN) Kidney Week 2025 convenes in Houston, Texas, from November 5-9, it will do so at a pivotal time for the field. For decades, progress in nephrology was measured in slow, incremental gains. However, the last decade has brought forth evidence of shifting momentum, with decades of foundational research translating into meaningful clinical advances across diseases once defined by limited options.

Throughout 2025, nephrology has welcomed landmark decisions from the US Food and Drug Administration (FDA) underscoring how far renal science has come. Pegcetacoplan (Empaveli) became the first approved therapy for C3 glomerulopathy and IC-MPGN, setting a new benchmark for glomerular disease care. Obinuztumuab (Gazyva) received the long-anticipated nod for lupus nephritis. The approval of atrasentan (Vanrafia) added an additional tool to the growing armamentarium for IgA nephropathy (IgAN). Outside of rare glomerular disease, finerenone (Kerendia) expanded its footprint beyond type 2 diabetes, gaining an indication in heart failure with preserved ejection fraction and hinting at broader potential in kidney protection. In parallel, the field has seen new targets emerge for C3G, FSGS, and rare metabolic nephropathies, illustrating a pipeline as diverse as it is deep.^1,2,3,4

Against this backdrop, Kidney Week 2025 represents more than the final major meeting of the year, it also represents the culmination of decades of persistence by a research community committed to changing the trajectory of kidney disease. The trials set to take the stage in Houston will not only build on these milestones but may also help shape the next wave of disease-modifying and precision therapies entering clinical practice.

Below, we highlight 5 high-impact, phase 3 clinical trials to watch from ASN Kidney Week 2025, listed chronologically by presentation date and time.

ASN Kidney Week 2025: 5 Phase 3 Trials to Know

1. Finerenone in CKD and Type 1 Diabetes

Session Time and Title: November 6, 8:50 AM CT; Opening Plenary: ASN President's Address, State-of-the-Art Lecture, Featured High-Impact Clinical Trials
Presenter: Hiddo Heerspink, PhD, PharmD
Summary: One of 2 studies presented in the meeting’s plenary session, FINE-ONE is among the most anticipated trials in recent years. A phase 3 trial among adults with chronic kidney disease (CKD) and type 1 diabetes (T1D), a population with limited treatment options and no new approved therapies in nearly 30 years, the trial will assess whether finerenone (Kerendia) can reduce albuminuria over 6 months, with the goal of slowing CKD progression in this high-risk group.

Finerenone boasts an FDA approval for CKD associated with type 2 diabetes dating back to 2023 and received approval in July 2025 for heart failure with preserved ejection fraction based on the FINEARTS-HF trial. FINE-ONE has the potential to extend evidence of the drug’s kidney-protective effects to an underserved T1D population where residual risk remains high despite standard care.

2. ORIGIN 3: A Phase 3 Trial of Atacicept in IgAN

Session Time and Title: November 6, 9:02 AM CT; Opening Plenary: ASN President's Address, State-of-the-Art Lecture, Featured High-Impact Clinical Trials
Presenter: Richard Lafayette, MD
Summary: Vera Therapeutics will present primary results from the ORIGIN phase 3 trial, evaluating atacicept in IgAN. Atacicept, a dual BAFF/APRIL inhibitor, met its primary endpoint with a statistically significant and clinically meaningful reduction in proteinuria at 36 weeks, reinforcing earlier Phase IIb findings of eGFR stabilization and reduced hematuria.

The drug, which received FDA Breakthrough Therapy Designation, offers a targeted, B-cell–modulating approach to IgAN and is being positioned for best-in-class potential. In addition to the presentation during the meeting’s plenary session, ORIGIN Extend and PIONEER trial updates will also be shared, exploring atacicept's role in other autoimmune glomerular diseases.

3. Efficacy and Safety of Telitacicept in Patients with IgAN: Results from Stage A of a Phase 3 Clinical Study

Session Time and Title: November 8, 10:45 AM CT; High-Impact Clinical Trials - 2
Presenter: Jicheng Lv, MD
Summary: Late-breaking presentations at ASN Kidney Week 2025 will also include from Stage A of a phase 3 trial of telitacicept, a dual BAFF/APRIL inhibitor, in IgAN. Developed by Vor Bio and collaborator RemeGen, telitacicept achieved a 55% reduction in 24-hour proteinuria at 39 weeks versus placebo (P <.0001), meeting its primary endpoint with a favorable safety profile. Telitacicept’s mechanism targets autoreactive B cells and plasma cells, positioning it as a potent therapy in autoantibody-driven kidney disease. The agent is already approved in China for SLE, RA, and gMG, with the company suggesting IgAN data supports potential regulatory expansion.

4. Efficacy and Safety of MIL62, a Glycoengineered Type II Anti-CD20 Antibody, in Primary Membranous Nephropathy: A Phase 3, Randomized, Controlled Trial

Session Time and Title: November 8, 11:15 AM CT;High-Impact Clinical Trials - 2
Presenter: Zhao Cui, MD, PhD
Summary: New phase 3 data will be presented on MIL62, a third-generation, glycoengineered anti-CD20 antibody, in primary membranous nephropathy (PMN). Developed by Beijing Mabworks Biotech Co. to enhance antibody-dependent cellular cytotoxicity (ADCC), MIL62 has shown promise as a novel B-cell–depleting therapy and has received Breakthrough Therapy Designation in China.

This trial positions MIL62 as a potential first-in-class targeted agent for PMN, with implications for broader use across autoimmune nephropathies and oncology.

5. Sibeprenlimab for the Treatment of IgAN: VISIONARY Phase 3 Interim and Prespecified Subgroup Analyses

Session Time and Title: November 8, 11:30 AM CT;High-Impact Clinical Trials - 2
Presenter: Vlado Perkovic, MBBS, PhD
Summary: Otsuka will present interim data and respecified subgroup analyses from the phase 3 VISIONARY trial, which is billed by Otsuka as the largest IgAN study to date. In June 2025, the company announced the trial demonstrated nine months, sibeprenlimab, a selective APRIL inhibitor, achieved a 51.2% reduction in 24-hour proteinuria vs placebo (P <.0001), with a favorable safety profile at 9 months.

As APRIL drives the formation of pathogenic Gd-IgA1 immune complexes, sibeprenlimab offers a targeted, immunologic approach to IgAN distinct from current therapies. Backed by FDA Priority Review, this agent, which was developed bya subsidiary of Otsuka named Visterra, may emerge as a first-in-class, self-administered biologic for this chronic kidney disease.

References:

1. Brooks A. FDA Approves Pegcetacoplan (Empaveli) for C3 Glomerulopathy, IC-MPGN. Hcplive.com. Published July 28, 2025. Accessed November 3, 2025. https://www.hcplive.com/view/fda-approves-pegcetacoplan-empaveli-for-c3-glomerulopathy-ic-mpgn

2. Brooks A. FDA Approves Obinutuzumab (Gazyva) for Lupus Nephritis. Hcplive.com. Published October 20, 2025. Accessed November 3, 2025. https://www.hcplive.com/view/fda-approves-obinutuzumab-gazyva-for-lupus-nephritis

3. Campbell P. Atrasentan (Vanrafia) Receives Accelerated Approval in IgA Nephropathy. HCPLive.com. Published April 3, 2025. Accessed November 3, 2025. https://www.hcplive.com/view/atrasentan-vanrafia-receives-accelerated-approval-in-igan

4. Campbell P. FDA Approves Finerenone (Kerendia) for Heart Failure with Ejection Fraction of 40% or More. HCPLive.com. Published July 14, 2025. Accessed November 3, 2025. https://www.hcplive.com/view/fda-approves-finerenone-kerendia-for-heart-failure-with-ejection-fraction-of-40-or-more