Nephrology Month in Review: June 2025

June proved to be an eventful month in nephrology, delivering a wave of regulatory actions, new clinical trial data, and expert insights into the evolving landscape of chronic kidney disease (CKD) and glomerular diseases.

The US Food and Drug Administration’s approval of a subcutaneous belimumab autoinjector for pediatric lupus nephritis offers a new level of convenience in managing this complex condition, while a Complete Response Letter (CRL) for oxylanthanum carbonate highlighted ongoing challenges in CKD-related phosphate binder development.

Simultaneously, key advances in IgA nephropathy (IgAN) took center stage, with atacicept achieving its primary endpoint in a pivotal phase 3 trial and multiple agents targeting APRIL/BAFF pathways making headlines at the 62nd European Renal Association (ERA 2025) Congress. Kidney Compass added depth to these updates, offering real-time analysis of the CONFIDENCE, VISIONARY, and PROTECT trials and illuminating practice-changing strategies for a broad spectrum of renal diseases.

Check out this June 2025 nephrology month in review for a recap of HCPLive’s coverage of the top renal news and research from the past few weeks:

Renal FDA News and Trial Updates

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 lupus nephritis offers patients and caregivers a first-of-its-kind subcutaneous option that can be administered at home.

FDA Issues CRL to Oxylanthanum Carbonate for Hyperphosphatemia in CKD, Dialysis

On June 30, 2025, the FDA issued a CRL to Unicycive Therapeutics’ New Drug Application for oxylanthanum carbonate for the treatment of hyperphosphatemia in patients with CKD on dialysis, citing deficiencies previously identified at a third-party manufacturing vendor unrelated to oxylanthanum carbonate. In the absence of concerns related to pre-clinical, clinical, or safety data, the Company indicated plans to seek a Type A meeting with the FDA to align on the best strategy to ensure “rapid resolution” of the CRL.

Atacicept Achieves Endpoints in Phase 3 ORIGIN Trial for IgA Nephropathy

On June 2, 2025, Vera Therapeutics announced that atacicept, an investigational recombinant fusion protein in development for the treatment of IgAN, met its primary endpoint of a statistically significant reduction in urine protein-to-creatinine ratio compared with placebo in the phase 3 ORIGIN trial. Based on the data, the Company plans to submit a Biologics License Application in the fourth quarter of 2025, opening the possibility for the drug’s commercial launch in 2026.

Related: Phase 3 ORIGIN Sets Stage for Atacicept in IgA Nephropathy, with Richard Lafayette, MD

HCPLive at ERA 2025

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

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

Pegcetacoplan Sustains Proteinuria Reductions in C3G, IC-MPGN at 52 Weeks

Extended data from the phase 3 VALIANT trial support the sustained efficacy and safety of pegcetacoplan (Empaveli) in patients with C3 glomerulopathy (C3G) or idiopathic immune-complex membranoproliferative glomerulonephritis (IC-MPGN), including adolescents and adults with native or transplanted kidneys. Presented at ERA 2025, the 52-week results show continued proteinuria reduction and eGFR stabilization in both treatment-naïve and crossover groups, reinforcing the 26-week data presented at the American Society of Nephrology’s 2024 Scientific Sessions.

Kidney Compass at ERA 2025

At the ERA 2025, HCPLive’s flagship nephrology podcast Kidney Compass: Navigating Clinical Trials delivered 3 focused conversations with leading nephrologists breaking down pivotal trial data and shifting paradigms in CKD and IgAN.

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

In the first episode, host Brendon Neuen, MBBS, PhD, sat down with Rajiv Agarwal, MD, to unpack results from the CONFIDENCE trial, discussing how findings support dual-agent initiation as a potentially practice-changing approach and offer early and amplified renal protection in a high-risk population.

The phase 2 trial randomized 800 patients across 3 arms—empagliflozin alone, finerenone alone, or the combination. At 180 days, combination therapy produced a 52% reduction in urinary albumin-to-creatinine ratio, outperforming both monotherapy groups (29% greater reduction vs finerenone, 32% vs empagliflozin; P < .001 for both). Additionally, the combination was well-tolerated.

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

In the second special edition episode, Vlado Perkovic, MBBS, PhD, joined hosts Neuen and Shikha Wadhwani, MD, MS, to discuss the VISIONARY trial—the largest phase 3 study in IgAN to date, enrolling 510 patients to evaluate the efficacy of sibeprenlimab, an APRIL inhibitor, versus placebo.

After 9 months, sibeprenlimab led to a 50.2% reduction in 24-hour urine protein-to-creatinine ratio (uPCR), while placebo saw a slight increase, yielding a net between-group difference of 51.2% (P <.0001). Perkovic emphasized the significance of these findings in a cohort where 98% were already on RAS inhibitors and nearly 40% were on SGLT2 inhibitors.

Kidney Compass: Key Updates in IgA Nephropathy at ERA 2025, with Chee Kay Cheung, MBChB, PhD

In the final ERA 2025 episode, Wadhwani met with Chee Kay Cheung, MBChB, PhD, for a forward-looking discussion on the rapidly evolving IgAN pipeline. The conversation also touched on data from approved agents: budesonide’s consistent efficacy across eGFR ranges in post-hoc NefIgArd analysis, and sparsentan’s continued benefit in the PROTECT trial’s open-label extension.

Looking ahead, Cheung previewed the SPARTAN study’s biopsy data, expected to provide insight into how sparsentan modulates renal inflammation and fibrosis at the tissue level.