8 Nephrology Headlines You Missed in November 2025

November witnessed dynamic activity in the nephrology landscape. From coverage at the American Society of Nephrology (ASN) Kidney Week 2025 to breakthroughs in IgA nephropathy (IgAN) management, approvals from the US Food and Drug Administration (FDA), and late-stage trial results, HCPLive has captured the most important developments shaping kidney care this month.

Highlights from this month showcase the rapid evolution of kidney therapeutics and clinical management. In IgAN, emerging immune-targeted therapies, including sibeprenlimab, telitacicept, atacicept, and others, are demonstrating meaningful reductions in proteinuria, improvements in pathogenic biomarkers, and signs of disease-modifying potential for patients at risk of progression. Advances in focal segmental glomerulosclerosis (FSGS) and membranous nephropathy further reinforce the potential of agents such as sparsentan and MIL62 to improve remission rates and long-term kidney outcomes.

Progress in kidney transplantation and immunosuppression, from safer rejection prevention with tegoprubart to supportive data on post-transplant pregnancies, offers actionable insights for clinicians managing complex cases. Developments across chronic kidney disease (CKD), dialysis, and rare kidney disorders, including new FDA orphan designations and late-stage trial readouts, continue to expand the therapeutic landscape and inform evidence-based care.

Check out this November 2025 nephrology month in review for a recap of HCPLive’s coverage of the top renal news and research from the past few weeks:

FDA Awards Accelerated Approval to Sibeprenlimab in IgA Nephropathy

The FDA awarded accelerated approval to sibeprenlimab (Voyxact), a targeted APRIL inhibitor, for adults with IgAN at risk for disease progression. The phase 3 VISIONARY trial showed promising safety, a 54.3% reduction in proteinuria, galactose-deficient immunoglobulin A1 (Gd-IgA1), and other disease biomarkers, offering a new option for patients at risk of progressive kidney disease.

Telitacicept Achieves Primary Endpoint in IgA Nephropathy Phase 3 Study

The B-cell modulating biologic telitacicept met its primary endpoint in a multicenter, double-blind phase 3 study. Investigators reported a -58.9% change in 24-hour urine protein-to-creatinine ratio (24h-UPCR) versus -8.8% for placebo (P <.0001), alongside a favorable safety profile, supporting its potential as a disease-modifying therapy in high-risk IgAN patients.

Understanding Atacicept & 36-Week ORIGIN 3 Data from Kidney Week 2025, With Jonathan Barratt, MBChB, PhD

Interim results from the ORIGIN-3 trial, presented at ASN Kidney Week 2025, showed that dual BAFF/APRIL inhibitor atacicept led to a 68.3% decrease in Gd-IgA1, resolution of dipstick hematuria in 81.0% of patients, and a 47.3% reduction in urinary albumin-to-creatinine ratio. Jonathan Barratt, MBChB, PhD, outlines atacicept’s role in the evolving IgAN pathway below.

PROTECT: Sparsentan Offers CV Protection Benefits as First-Line Therapy in IgAN

A 24-week analysis from the SPARTAN study suggests sparsentan (Filspari), a dual endothelin and angiotensin receptor antagonist, produces rapid proteinuria reductions (~70%) alongside favorable trends in blood pressure, cardiac structure, and cardiovascular biomarkers, supporting its use as first-line therapy in adults with IgAN.

The phase 3 DUPLEX trial showed sparsentan achieved earlier and more frequent reductions in proteinuria (UPCR <0.7 g/g) and improved long-term kidney outcomes compared with irbesartan in patients with focal segmental glomerulosclerosis (FSGS).

MIL62 Shows Increased Remission and Reduced Relapse Versus Cyclosporine A in MN

In adults with primary membranous nephropathy (MN), MIL62 achieved complete remission in 49.4% of patients by week 76 versus 3.9% with cyclosporine A. Overall remission rates were consistently higher at weeks 24, 52, and 76 (all P <.001), demonstrating durable disease control.

BESTOW: Tegoprubart Showcases Safer Prevention of Kidney Transplant Rejection Over Tacrolimus

Phase 2 BESTOW trial data suggest tegoprubart offers similar improvements in estimated glomerular filtration rate (eGFR) as tacrolimus while providing a better safety profile, potentially shifting the transplant immunosuppression paradigm.

Global Data Support Successful Pregnancy Outcomes in Kidney Transplant Recipients

Registry analyses from multiple continents show that pregnancy after kidney transplantation can be successfully managed, with favorable maternal, neonatal, and graft outcomes. These findings highlight the importance of close clinical surveillance and the need for continued global data harmonization to support high-risk pregnancies/

FDA Grants Orphan Drug Designation to ABBV-CLS-628 for ADPKD

The FDA granted orphan drug designation to ABBV-CLS-628 for autosomal dominant polycystic kidney disease (ADPKD). Although early in development, this designation underscores ongoing efforts to expand treatment options for rare kidney diseases and supports continued research into disease-modifying therapies.