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.
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.