Q3 2025 Recap: Nephrology News and Updates

The third quarter of 2025 brought several regulatory updates, clinical guideline updates, and notable renal research, underscoring the rapidly evolving landscape in nephrology. From IgA nephropathy (IgAN) and C3 glomerulopathy (C3G) to focal segmental glomerulosclerosis (FSGS) and xenotransplantation, a string of US Food and Drug Administration actions—including approvals, label updates, and advisory committees —signal increasing momentum for therapeutic innovation across a range of kidney diseases.

With growing progress in IgAN, Kidney Disease: Improving Global Outcomes (KDIGO) released a new Clinical Practice Guideline to address recent changes in its diagnosis and management. Meanwhile, research about the global burden of chronic kidney disease (CKD), trends in hypertensive kidney disease mortality, and use of spironolactone among patients receiving maintenance dialysis for kidney failure shed light on other developments in the field.

Check out this recap of what made headlines in Q3 of 2025:

FDA Approves Pegcetacoplan (Empaveli) for C3 Glomerulopathy, IC-MPGN

On July 28, 2025, the FDA approved Apellis Pharmaceuticals’ pegcetacoplan (Empaveli) for the treatment of C3G and IC-MPGN in patients ≥ 12 years of age based on positive 26-week results from the phase 3 VALIANT trial, the largest single trial conducted in patients with C3G and IC-MPGN and the only study to include adolescent and adult patients with native and post-transplant kidneys. The approval indicates the agent for adults and adolescents with C3G or primary IC-MPGN, and post-transplant C3G disease recurrence.

Related: Entering A New Era of C3G Care with Pegcetacoplan, with Carla Nester, MD

FDA Approves REMS Label Update for Sparsentan (Filspari) in IgA Nephropathy

On August 27, 2025, the FDA approved an updated Risk Evaluation and Mitigation Strategy (REMS) labeling for sparsentan (Filspari) for the treatment of IgAN, reducing the frequency of liver function monitoring from monthly to every 3 months from the onset of treatment and removing the embryo-fetal toxicity monitoring requirement.

FDA Clears IND Application for EGEN-2784, a Genetically Engineered Pig Kidney, for ESKD

On September 8, 2025, the FDA cleared an IND application from eGenesis to initiate a clinical trial evaluating EGEN-2784, a genetically engineered porcine-derived kidney, in patients with ESKD. The IND supports a phase 1/2/3 study designed to assess the safety, tolerability, and efficacy of EGEN-2784 at 24 weeks post-transplant in patients with ESKD who are ≥ 50 years of age, dialysis-dependent, and on the kidney transplant waitlist.

Related: Xenotransplantation: A New Frontier in Kidney Transplantation, With Pranav Garimella, MBBS, MPH

FDA Removes Sparsentan (Filspari) Advisory Committee Meeting for FSGS sNDA

On September 10, 2025, the FDA informed Travere Therapeutics that following further review of the sNDA for sparsentan (Filspari) in FSGS, an advisory committee is no longer needed. The sNDA remains under review by the FDA with a Prescription Drug User Fee Act (PDUFA) target action date of January 13, 2026. If approved, sparsentan would be the first medication indicated for FSGS.

KDIGO Releases Updated IgA Nephropathy, IgA Vasculitis Clinical Practice Guideline

On September 18, 2025, KDIGO released its 2025 Clinical Practice Guideline for the Management of IgAN and IgAV, providing comprehensive, evidence-based recommendations for clinicians managing these kidney diseases. The document builds upon the last update to the IgAN and IgAV management guideline published as part of the KDIGO 2021 Clinical Practice Guideline for the Management of Glomerular Diseases.

Global CKD Burden Attributable to Obesity on the Rise

Findings from this study shed light on increases in the global burden of CKD, showing that from 1990 to 2021, while the overall CKD burden increased slowly, CKD-related deaths, disability-adjusted life-years, and corresponding age-standardized rates attributable to high BMI exhibited a more pronounced and sustained growth. In addition to this historical upward trend, study findings project further increases in the burden of CKD attributable to high BMI by 2050.

Hypertensive Kidney Disease Death Rate Up 48% in Past 25 Years

Findings from an analysis of US Centers for Disease Control and Prevention - Wide-Ranging Online Data for Epidemiology Research (CDC WONDER) data show the death rate from hypertensive kidney disease in the US has increased by 48% since 1999. In addition to the stark increase in high blood pressure-related renal disease mortality over the past 25 years, study findings highlight disproportionate impacts on African American and Hispanic males.

Spironolactone Shows No Cardiovascular Benefit in Dialysis Patients

Among patients receiving maintenance dialysis for kidney failure, spironolactone 25 mg daily orally does not reduce cardiovascular mortality and hospitalization due to heart failure compared with placebo, according to findings from the ACHIEVE trial. The international, parallel-group, randomized controlled trial was conducted in 143 dialysis programs across 12 countries and was stopped early for futility at the recommendation of the external safety and efficacy monitoring committee after a planned interim analysis of 75% of the expected primary outcome events.