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Nephrology in September 2026: FDA approves finerenone for CKD in T1D and obinutuzumab for nephrotic syndrome, plus ORIGIN 3 IgAN data.
Nephrology news in September 2026 included 2 US Food and Drug Administration (FDA) approvals in chronic kidney disease (CKD) and nephrotic syndrome, final phase 3 data in IgA nephropathy (IgAN), and expert perspective on kidney disease detection and glomerular disease care.
The FDA approved finerenone (Kerendia) to reduce albuminuria in adults with CKD associated with type 1 diabetes. Later in the month, obinutuzumab (Gazyva) was approved for relapse prevention in patients with frequently relapsing or steroid-dependent idiopathic nephrotic syndrome, adding to its existing indication in lupus nephritis.
In IgAN, final results from the phase 3 ORIGIN 3 trial showed that atacicept (Trutakna), which inhibits B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL), preserved kidney function through 2 years. The data support a planned application for full approval, following the drug's accelerated approval in July 2026.
Coverage also focused on detection and coordination of care. As the US Preventive Services Task Force (USPSTF) reviews evidence on CKD screening, the American Kidney Fund highlighted how often the disease goes undiagnosed, and a new American Society of Nephrology (ASN) resource aims to consolidate guidance on glomerular disease.
On September 16, 2026, the FDA approved finerenone (Kerendia) to reduce urinary albumin-to-creatinine ratio (UACR) in adults with CKD associated with type 1 diabetes. The approval was based on the phase 3 FINE-ONE trial, in which finerenone reduced UACR by 28% compared with placebo at month 6. Hyperkalemia occurred in 10.1% of patients receiving finerenone and 3.3% receiving placebo. Bayer described it as the first new treatment option for this population in more than 30 years.
On September 25, 2026, the FDA approved obinutuzumab (Gazyva) for relapse prevention in patients aged 2 years and older with frequently relapsing or steroid-dependent childhood-onset idiopathic nephrotic syndrome in complete remission. In the phase 3 INShore trial, 95.5% of patients receiving obinutuzumab maintained complete remission at week 52, compared with 73.2% receiving mycophenolate mofetil. Genentech's obinutuzumab was approved for lupus nephritis in 2025.
Final phase 3 ORIGIN 3 data from Vera Therapeutics showed that atacicept (Trutakna) reduced the risk of kidney disease progression by 76% compared with placebo in 428 patients with IgAN. Annualized estimated glomerular filtration rate (eGFR) decline through 104 weeks was 0.6 mL/min/1.73 m² per year with atacicept and 5.6 with placebo. No patients receiving atacicept required dialysis or transplant or died, compared with 8 events with placebo. Vera plans to submit a supplemental application for full approval in the fourth quarter of 2026.
Sayna Norouzi, MD, of Loma Linda University Medical Center, discusses the ORIGIN 3 final analysis, in which atacicept slowed eGFR decline to a rate close to normal age-related loss. She covers why preserving kidney function is the outcome patients ask about most, how the results relate to KDIGO treatment targets, and the trial's safety findings, including similar infection rates with atacicept and placebo.
Pranav Garimella, MBBS, MPH, chief medical officer of the American Kidney Fund, discusses why 87% of US adults with CKD are unaware of their diagnosis and what the USPSTF should consider in its evidence review on CKD screening. He covers the gap between eGFR and UACR testing in patients with type 2 diabetes, high-risk groups for screening, the need for repeat testing to confirm CKD, and newer therapies such as sodium-glucose cotransporter 2 (SGLT2) inhibitors, finerenone, and glucagon-like peptide-1 (GLP-1) receptor agonists.
George Vasquez-Rios, MD, MSCR, of Renal Medicine Associates, discusses the ASN Glomerular Diseases Collaborative (GD-C) Compendium, which consolidates guidance on glomerular diseases including IgAN, lupus nephritis, ANCA-associated vasculitis, C3 glomerulopathy, and membranous nephropathy. He explains how the compendium serves both general nephrologists and specialists, includes a recognition-to-referral pathway and guidance on prior authorizations, and is updated about every 6 months.