First Half 2026 Recap: Nephrology

The first half of 2026 marked a transformative period in nephrology, with landmark regulatory approvals, evolving clinical practice guidelines, and pivotal phase 3 trial results accelerating a shift toward precision medicine and disease modification. Across chronic kidney disease (CKD), IgA nephropathy (IgAN), focal segmental glomerulosclerosis (FSGS), and other glomerular diseases, the US Food and Drug Administration (FDA) advanced multiple therapies through priority reviews and approvals while investigators reported encouraging long-term data from late-stage clinical trials.

The first six months of the year also saw important updates to clinical care, including the release of the Kidney Disease: Improving Global Outcomes (KDIGO) 2026 Clinical Practice Guideline for Anemia in CKD and growing emphasis on earlier diagnosis, biomarker-guided risk stratification, and individualized treatment strategies. Together, these developments reflect a rapidly evolving nephrology landscape increasingly focused on preserving kidney function, targeting underlying disease mechanisms, and improving long-term patient outcomes.

Catch up on some of the biggest FDA news, clinical trial updates, and featured HCPLive coverage from the first half of 2026.

FDA News & Guideline Updates

KDIGO Releases New Guideline for Anemia in Chronic Kidney Disease

Released on January 5, the KDIGO 2026 Clinical Practice Guideline for the Management of Anemia in CKD updated recommendations for diagnosis, iron replacement, erythropoiesis-stimulating agents, HIF-PHIs, and red blood cell transfusions. The guideline emphasizes individualized treatment decisions, shared decision-making, and symptom-driven management over fixed hemoglobin thresholds.

FDA Approves Sparsentan for FSGS

On April 13, 2026, the FDA granted full approval to sparsentan for the treatment of FSGS, marking the first approved therapy specifically indicated for the rare glomerular disease. Supported by data from the phase 3 DUPLEX and phase 2 DUET trials, the approval represented a landmark moment for patients and clinicians after decades of reliance on supportive care and off-label immunosuppression.

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 following positive interim ORIGIN 3 data. At week 36, treatment reduced proteinuria by 46% from baseline and 42% compared with placebo (P <.0001), supporting the therapy's potential as another disease-modifying option in IgAN.

FDA Grants Priority Review to Finerenone for Type 1 Diabetes and CKD

Based on positive results from the phase 3 FINE-ONE trial, the FDA accepted Bayer's supplemental New Drug Application and granted Priority Review for finerenone in adults with type 1 diabetes and CKD on May 21, 2026. If approved, the indication would expand treatment options for a patient population with few therapies proven to slow kidney disease progression.

FDA Issues CRL for Oxylanthanum Carbonate in Hyperphosphatemia for CKD Patients on Dialysis

On June 30, 2026, Unicycive Therapeutics announced that the FDA issued a Complete Response Letter (CRL) for oxylanthanum carbonate (OLC) in the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. According to the announcement, the FDA did not raise any concerns regarding clinical efficacy or safety data and no additional data was requested from Unicycive Therapeutics.

Clinical Trial Updates

APPLAUSE-IgAN: Iptacopan (Fabhalta) Exhibits 49.3% Slower eGFR Decline in IgAN Patients Than Placebo

Final 2-year results from the phase 3 APPLAUSE-IgAN trial showed iptacopan reduced the rate of eGFR decline by 49.3% compared with placebo while lowering the risk of kidney failure events by 43%. The findings strengthen evidence supporting complement inhibition as a disease-modifying strategy in IgAN.

RAINIER: Povetacicept Reduces Proteinuria by 52%

36-week interim results from the ongoing phase 3 RAINIER trial showed povetacicept achieved a 52.0% reduction in urine protein-to-creatinine ratio (UPCR) from baseline and a 49.8% reduction versus placebo (P <.0001). The findings support continued development of the dual APRIL/BAFF inhibitor for adults with IgAN.

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

Results from the phase 3 MAJESTY trial demonstrated obinutuzumab met its primary endpoint of complete remission at 2 years compared with tacrolimus in patients with primary membranous nephropathy, positioning the therapy to potentially become the first FDA-approved treatment for the disease.

Kidney Compass: Rituximab Cuts Relapse Risk in MCD, FSGS in TURING Trial

Late-breaking data presented at the European Renal Association (ERA) 2026 demonstrated that rituximab significantly reduced relapse risk in adults with minimal change disease and FSGS, adding prospective evidence supporting its role in primary glomerular diseases.

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

Phase 2a results from TACITO suggested fecal microbiota transplantation enhanced responses to pembrolizumab plus axitinib in metastatic renal cell carcinoma, highlighting the growing interest in microbiome-targeted strategies to improve cancer immunotherapy outcomes.

9-Protein Plasma Score Predicts Kidney Failure Risk in APOL1 High-Risk Individuals

Investigators developed and validated a plasma proteomic risk score capable of identifying APOL1 high-risk individuals most likely to progress to kidney failure years before declines in eGFR or increases in albuminuria become apparent, underscoring the expanding role of biomarkers in precision nephrology.

Featured Content

IgAN Enters the "Mechanism-First Era"

In recognition of IgAN Awareness Day, HCPLive spoke with leading nephrologists about how disease-modifying therapies are reshaping clinical care. Experts discussed earlier diagnosis, treatment sequencing, biomarker development, and evolving definitions of remission as the field moves beyond supportive care alone.

The Pillared Approach Continues to Reshape CKD Care

Katherine Tuttle, MD, discussed how combining RAAS inhibition, SGLT2 inhibitors, GLP-1 receptor agonists, and mineralocorticoid receptor antagonists has shifted CKD management toward a comprehensive, disease-modifying strategy aimed at slowing kidney disease progression while reducing cardiovascular risk.

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

This special edition of Crisis Point examined how neighborhood disadvantage influences CKD outcomes beyond traditional clinical risk factors, highlighting the importance of addressing social determinants of health alongside advances in therapeutics.

ISGD and the Fastest 5 Years in Glomerular Disease

Leaders from the International Society of Glomerular Disease reflected on the rapid scientific progress that has transformed understanding of glomerular diseases over the past five years, discussing how advances in disease biology have accelerated therapeutic development and changed expectations for patient care.