The first quarter of 2026 marked a pivotal period in nephrology, with major regulatory decisions, guideline updates, and late-phase clinical trial readouts reshaping the treatment landscape for chronic kidney disease (CKD) and glomerular disorders. The US Food and Drug Administration advanced multiple high-impact therapies across focal segmental glomerulosclerosis (FSGS), IgA nephropathy (IgAN), and dialysis-related complications, including priority review for atacicept and continued evaluation of sparsentan and oxylanthanum carbonate. At the same time, the Kidney Disease: Improving Global Outcomes released its 2026 Clinical Practice Guideline for anemia in CKD, introducing updated recommendations on iron therapy, erythropoiesis-stimulating agents, and transfusion strategies, with an increased emphasis on individualized, symptom-driven care.

Parallel to these regulatory and guideline shifts, phase 2 and 3 trial data underscored continued momentum in precision nephrology and immunologic targeting. Studies such as TACITO, MAJESTY, and RAINIER highlighted emerging therapies ranging from microbiome-modulating strategies in kidney cancer to B-cell–targeted approaches and novel immunotherapies for proteinuric kidney diseases. Together, these developments reflect a rapidly evolving nephrology pipeline, with growing therapeutic diversity and a stronger focus on disease modification.

Beyond clinical and regulatory advances, thought leadership in the field continued to expand the conversation around kidney disease. Coverage this quarter explored the intersection of social determinants and CKD outcomes, as well as the accelerating pace of discovery in glomerular disease, reinforcing a broader shift toward holistic, patient-centered, and biologically driven care in nephrology.

Catch up on any of the FDA news, trial updates, and featured content you missed in Q1 2026.

FDA News/Guideline Updates

FDA Extends Sparsentan (Filspari) sNDA Review for Focal Segmental Glomerulosclerosis

On January 13, 2026, the FDA announced its extended review of the supplemental New Drug Application (sNDA) for sparsentan (Filspari) to treat focal segmental glomerulosclerosis (FSGS). After the drug received a Major Amendment, the FDA moved the new PDUFA target action date to April 13, 2026

FDA Grants Priority Review Of Biologics License Application For Atacicept In IgA Nephropathy

Atacicept, a B-cell modulating therapy, for adults with IgAN received priority review of its Biologics License Application, supported by interim data analysis from ORIGIN 3, which met its primary endpoint of proteinuria reduction at week 36, with a 46% reduction compared to baseline, and a 42% reduction compared to placebo (P < .0001).

FDA Accepts Oxylanthanum Carbonate NDA Resubmission for Hyperphosphatemia in CKD, Dialysis

The FDA accepted Unicycive Therapeutics’ NDA for oxylanthanum carbonate (OLC) for the treatment of hyperphosphatemia in patients with CKD on dialysis on January 29, 2026. The Agency has deemed the OLC resubmission to be a Class II complete response, which has a 6-month review period from the date of resubmission. The PDUFA target action date is June 29, 2026.

KDIGO Releases New Guideline for Anemia in Chronic Kidney Disease

On January 5, 2026, KDIGO Anemia Work Group released the 2026 Clinical Practice Guideline for the Management of Anemia in CKD. Broken down into 4 main chapters, the first addresses the diagnosis and evaluation of anemia and iron deficiency in patients with CKD, including prevalence, pathophysiology, and clinical outcomes. The second focuses on iron therapy for anemia in CKD and prioritizes intravenous iron over oral formulations. The third chapter covers the use of erythropoiesis-stimulating agents and HIF-PHIs to raise hemoglobin, emphasizing shared decision-making and evaluation of alternative causes before treatment initiation. Lastly, the fourth outlines appropriate use of RBC transfusions, highlighting potential risks and recommending symptom-based assessment rather than hemoglobin thresholds alone.

Trial Updates

TACITO: Fecal Microbiota Transplantation Improves Immunotherapy Response in Advanced Kidney Cancer

New evidence from the ​​phase 2a TACITO trial suggests FMT improves the effectiveness of immunotherapy in patients with advanced mRCC receiving pembrolizumab and axitinib, based on a hypothesis that transplanting favorable gut microbiome could enhance a patient’s response to immunotherapy.

MAJESTY: Obinutuzumab Achieves 2 Year Complete Remission in Primary Membranous Nephropathy

MAJESTY, the first global phase 3 study in primary membranous nephropathy (PMN), met its primary endpoint of complete remission at 2 years with obinutuzumab (Gazyva).

Genentech announced the positive 2-year phase 3 results of obinutuzumab compared to tacrolimus on February 16, 2026, with the potential for the therapeutic to become the first approved treatment for PMN.

RAINIER: Povetacicept Reduces Proteinuria By 52.0%

Povetacicept met its primary and secondary endpoints in RAINIER, an ongoing phase 3 trial evaluating adults with IgA nephropathy (IgAN), according to a 36-week interim analysis. Vertex Pharmaceuticals announced positive results where povetacicept showed a 52.0% reduction in urine protein to creatinine ratio (UPCR) compared to baseline, with a statistically significant and clinically meaningful 49.8% UPCR reduction compared to placebo (P < .0001).

Featured Content

Crisis Point: The Cause and Calamity, Neighborhood Disadvantage and Kidney Disease

Clinicians often thought of healthcare as having a problem and a solution, but this Crisis Point examined what was going on underneath the surface. With the rising threat of chronic kidney disease, more was at stake than the values measurable in a lab, this piece focused on the detrimental problem of neighborhood disadvantage as both the cause and the calamity of kidney disease.

ISGD and the Fastest 5 Years in Glomerular Disease

For experts from ISGD, the last 5 years were the fastest and most dynamic period in glomerular disease. In this special report, Barbara Gillespie, MD, an adult nephrologist at the University of North Carolina and Chief Medical and Strategy Officer at ISGD, and Toby Huber, MD, head of Internal Medicine at Hamburg-Eppendorf in Germany and founding president of ISGD, broke down the scientific advances and how they revolutionized biological understanding of glomerular diseases.