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October brings FDA approvals, new KDIGO guidance, and diagnostic breakthroughs
October delivered a slew of significant developments in nephrology, underscoring rapid momentum in both therapeutic innovation and clinical guidance. The month was highlighted by a landmark US Food and Drug Administration (FDA) approval in lupus nephritis for obinutuzumab, accompanied by new phase 3 data in IgA nephropathy (IgAN), reinforcing continued progress toward more effective, individualized treatment.
Beyond drug development, the month also reshaped the clinical framework for managing IgAN, with Kidney Disease: Improving Global Outcomes (KDIGO) releasing its 2025 practice guideline, optimizing early diagnosis, proteinuria reduction, and combination therapy sequencing in the expanding treatment landscape. Expert perspectives highlighted the role of targeted-release budesonide, complement inhibitors, endothelin antagonists, and therapies now entering late-phase trials.
Technology-driven innovation also made headlines, with promising results from an artificial intelligence–assisted model designed to improve the accuracy of glomerular disease diagnosis.
Check out this October 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 Approves Obinutuzumab for Lupus Nephritis
On October 20, 2025, the FDA approved Genentech’s obinutuzumab (Gazyva) for the treatment of lupus nephritis. The decision was based on positive results from the phase 2 NOBILITY and phase 3 REGENCY studies. In REGENCY, nearly half of the participants (46.4%) on obinutuzumab in combination with standard therapy achieved a complete renal response compared to 33.1% on standard therapy alone, accompanied by clinically meaningful improvements in complement levels and reductions in anti-dsDNA, corticosteroid use, and proteinuria.
APPLAUSE-IgAN: Iptacopan (Fabhalta) Meets eGFR Decline Primary Endpoint
On October 16, 2025, Novartis announced the final results from the phase 3 APPLAUSE-IGAN study of iptacopan (Fabhalta) in adults with IgAN, highlighting their positive implications for slowing annual estimated glomerular filtration rate decline. The company described plans to use data on the complement pathway inhibitor and oral alternative to support regulatory submissions in 2026.
Redefining IgAN Care: Key Updates From the KDIGO 2025 Guideline, With Jonathan Barratt, MD, PhD
HCPLive spoke to Jonathan Barratt, MD, PhD, University of Leicester, for further insight into the significance of KDIGO’s 2025 Clinical Practice Guideline for the Management of IgAN and IgAV and their clinical impact. Key takeaways were early diagnosis, intervention, and treatment, and a clinical goal of reducing proteinuria levels to <0.5 grams a day. With the evolving therapeutic landscape, clinicians need to further understand the implementation of combination therapy.
New Guidelines and Novel Therapies in IgA Nephropathy, With Jai Radhakrishnan, MD
Jai Radhakrishnan, MD, a professor of medicine at Columbia University Medical Center, spoke with HCPLive to further break down the KDIGO IgAN guidelines. Emphasizing the importance of targeted release budesonide, iptacopan, sparsentan, and atrasentan, he predicts the B cell inhibitors currently in phase 3 clinical trials will enter as new treatment options on the horizon.
Improved Glomerular Nephritis Diagnosis With Artificial Intelligence-Assisted Model
The first development of an AI-assisted model for glomerular nephritis diagnosis saw improvement in the standardization and effectiveness of kidney biopsy analysis as opposed to manually performed analysis by clinicians. The model proved a potential to limit interobserver variability, but faced the common clinician error of distinguishing between minimal change disease and focal segmental glomerulosclerosis.