Nephrology First Half Recap: 2025

The first half of 2025 brought major advancements in nephrology, with the US Food and Drug Administration approving semaglutide to slow chronic kidney disease (CKD) progression in type 2 diabetes and granting accelerated approval to atrasentan for proteinuria reduction in IgA nephropathy (IgAN). Sibeprenlimab also made headlines with strong phase 3 results and priority review status, and progress continued in lupus nephritis (LN) with new FDA activity around obinutuzumab and belimumab.

At the 62nd European Renal Association (ERA 2025) Congress, findings from the CONFIDENCE trial supported the safe co-initiation of finerenone and SGLT2 inhibitors, and data from an interim analysis of the phase 3 VISIONARY trial provided additional support for sibeprenlimab’s use in IgAN. The field of xenotransplantation also saw historic advancements, with the FDA clearing the first clinical trial for gene-edited pig kidneys and a second transplant performed at Mass General.

Here’s a recap of what made headlines in the first half of 2025:

FDA Approves Semaglutide (Ozempic) for Type 2 Diabetes, Chronic Kidney Disease

The year began with the FDA approval of Novo Nordisk’s semaglutide (Ozempic) to reduce the risk of kidney disease worsening, kidney failure, and death due to cardiovascular disease in adults with type 2 diabetes and CKD.

The decision was based on results from the phase 3b FLOW kidney outcomes trial demonstrating semaglutide’s statistically significant and superior 24% relative risk reduction of kidney disease worsening, end-stage kidney disease, and death due to cardiovascular disease compared with placebo when added to standard of care.

Related: Understanding Semaglutide for Diabetes and CKD, with Pranav Garimella, MBBS, MPH

FDA Accepts Obinutuzumab (Gazyva/Gazyvaro) sBLA for Lupus Nephritis

On March 5, 2025, Roche announced the FDA acceptance of the company’s supplemental Biologics License Application (sBLA) for obinutuzumab (Gazyva/Gazyvaro) for the treatment of lupus nephritis, supported by positive results from the phase 3 REGENCY study demonstrating improved complete renal response with obinutuzumab plus standard therapy. A decision on approval is expected by October 2025.

Atrasentan (Vanrafia) Receives Accelerated Approval in IgA Nephropathy

On April 2, 2025, the FDA granted accelerated approval to atrasentan (Vanrafia), a once-daily, non-steroidal, oral treatment, for reducing proteinuria in adults with primary IgAN at risk of rapid disease progression. Notably, the decision marked the FDA’s first approval for a selective endothelin A receptor antagonist for reducing protein in IgAN and came without any requirement for a Risk Evaluation Mitigation Strategy (REMS) program for use.

Related: Understanding Atrasentan (Vanrafia) for IgA Nephropathy, with Richard Lafayette, MD

FDA Accepts, Grants Priority Review to Sibeprenlimab BLA for IgA Nephropathy

On May 27, 2025, the FDA accepted and granted priority review to Otsuka Pharmaceutical Development & Commercialization’s Biologics License Application (BLA) for sibeprenlimab for the treatment of IgAN, which was supported by data from the phase 3 VISIONARY trial and the phase 2 ENVISION trial. With the acceptance, the FDA assigned a PDUFA target action date of November 28, 2025.

FDA Approves Belimumab (Benlysta) Autoinjector for Pediatric Lupus Nephritis

On June 24, 2025, the FDA approved a 200 mg/mL autoinjector of GlaxoSmithKline’s belimumab (Benlysta), a B-lymphocyte stimulator-specific inhibiting monoclonal antibody, for subcutaneous injection in patients ≥ 5 years of age with active lupus nephritis who are receiving standard therapy. Initially approved for pediatric patients with active systemic lupus erythematosus in 2024, the approval of the belimumab autoinjector for LN offers patients and caregivers a first-of-its-kind subcutaneous option that can be administered at home.

CONFIDENCE: SGLT2i and Finerenone Effective, Safe to Initiate Simultaneously in CKD

Findings from the CONFIDENCE trial presented at ERA 2025 suggest simultaneous initiation of finerenone (Kerendia) and empagliflozin (Jardiance) is well-tolerated and associated with a greater reduction in urinary albumin to creatinine ratio (UACR) than either therapy alone among patients with CKD and type 2 diabetes.

Related: Kidney Compass: CONFIDENCE Trial at ERA 2025, with Rajiv Agarwal, MD, MS

Sibeprenlimab Halves Proteinuria in IgAN in Phase 3 VISIONARY Trial

Findings from an interim analysis of the phase 3 VISIONARY trial show use of sibeprenlimab was associated with a 51.2% reduction in proteinuria at 9 months relative to placebo therapy among patients with IgAN, according to an interim analysis of the phase 3 VISIONARY trial. With its BLA acceptance in May, a decision on sibeprenlimab’s approval for IgAN is expected by November 28, 2025.

Related: Kidney Compass: Sibeprenlimab and the VISIONARY Trial, with Vlado Perkovic, MBBS, PhD, at ERA 2025

FDA Clears First Xenotransplant Trial for Gene-Edited Kidneys

On February 3, 2025, the FDA cleared United Therapeutics’ Investigational New Drug application to initiate a clinical study of the company’s investigational UKidney™ derived from a 10 gene-edited source pig. The study is expected to enroll an initial cohort of 6 patients with end-stage renal disease, expanding to up to 50 participants, and is intended to support a Biologics License Application with the FDA. The first xenotransplant in the trial is expected to be performed around mid-year 2025.

Second Xenotransplant with Gene-Edited Pig Kidney Performed at Mass General

Just days later, on February 7, 2025, Massachusetts General Hospital announced the successful completion of its second transplant of a pig kidney with 69 genomic edits provided by eGenesis into a 66-year-old male patient who had been on dialysis for more than 2 years due to end-stage kidney disease.

In March 2024, Massachusetts General Hospital became the first hospital in the world to transplant a genetically edited pig kidney into a living human. The latest 2.5-hour xenotransplant procedure was performed under the US Food and Drug Administration Expanded Access Protocol granted in December 2024, which is planned to support 2 additional xenotransplants this year.