6 Nephrology Headlines You Missed in August 2025

August 2025 delivered a wave of important updates in nephrology, spanning new US Food and Drug Administration (FDA) approvals, clinical trial readouts, and global public health insights. The FDA cleared 2 generic versions of iron sucrose injection for iron deficiency anemia in chronic kidney disease (CKD), expanding access to a widely used therapy, and also approved an updated REMS label for sparsentan (Filspari) in IgA nephropathy (IgAN), easing monitoring requirements for patients and clinicians.

Meanwhile, research offered new perspectives across kidney disease management, from pediatric kidney stone and primary glomerular disease management to the growing burden of CKD attributable to obesity and the cardiovascular benefit of spironolactone for dialysis patients.

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

FDA Approves 2 Generic Iron Sucrose Injections for Iron Deficiency Anemia in CKD

On August 11, 2025, the FDA approved Viatris Inc’s Iron Sucrose Injection, USP, an intravenous iron replacement product used to treat iron deficiency anemia in adult and pediatric patients ≥ 2 years of age with CKD. Concurrently, Amphastar Pharmaceuticals announced that the FDA approved the Company's Abbreviated New Drug Application for Iron Sucrose Injection, USP 50mg/2.5mL, 100mg/5mL, and 200mg/10mL in single-dose vials, previously referred to as AMP-002.

According to a press release from Viatris, Iron Sucrose Injection, USP, coined by the Company as the first generic version of Venofer Injection, is expected to be available imminently in single dose vials in the following strengths: 50 mg/2.5mL, 100mg/5mL and 200mg/10mL. In a separate release, Amphastar said its generic iron sucrose injection meets the criteria for bioequivalence and therapeutic equivalence to Venofer and is expected to launch in the third quarter of 2025.

FDA Approves REMS Label Update for Sparsentan (Filspari) in IgA Nephropathy

On August 27, 2025, the FDA approved an updated Risk Evaluation and Mitigation Strategy (REMS) labeling for sparsentan (Filspari) for the treatment of IgAN, reducing the frequency of liver function monitoring from monthly to every 3 months from the onset of treatment and removing the embryo-fetal toxicity (EFT) monitoring requirement.

Shockwave Lithotripsy for Pediatric Kidney Stones Linked to Faster Recovery, Less Pain

New research is challenging the preference for ureteroscopy for the treatment of pediatric kidney stones in clinical practice, with findings from the Pediatric KIDney Stone (PKIDS) Study suggesting shockwave lithotripsy may provide similar rates of stone clearance with faster recovery time and better patient-reported outcomes. Specifically, results showed ureteroscopy was associated with greater pain interference, urinary symptoms, and missed school 1 week after surgery compared with shockwave lithotripsy. Of note, there was no clinically meaningful difference in kidney stone clearance between the procedures.

Global CKD Burden Attributable to Obesity on the Rise

Findings from this study shed light on increases in the global burden of CKD. From 1990 to 2021, while the overall CKD burden increased slowly, CKD-related deaths, disability-adjusted life-years, and corresponding age-standardized rates attributable to high BMI exhibited a more pronounced and sustained growth. In addition to this historical upward trend, study findings project further increases in the burden of CKD attributable to high BMI by 2050.

Spironolactone Shows No Cardiovascular Benefit in Dialysis Patients

Among patients receiving maintenance dialysis for kidney failure, spironolactone 25 mg daily orally does not reduce cardiovascular mortality and hospitalization due to heart failure compared with placebo, according to findings from the ACHIEVE trial. The international, parallel-group, randomized controlled trial was conducted in 143 dialysis programs across 12 countries and was stopped early for futility at the recommendation of the external safety and efficacy monitoring committee after a planned interim analysis of 75% of the expected primary outcome events.

Hydroxychloroquine Effective for Proteinuria Reduction in Primary Glomerular Disease

New research calls attention to the potential benefits of hydroxychloroquine for the treatment of primary glomerular diseases, highlighting its impact on proteinuria reduction but lack of improvement in overall estimated glomerular filtration rate (eGFR). The systematic review found that while hydroxychloroquine was effective in reducing proteinuria levels irrespective of disease type and treatment duration, improvement in eGFR was limited to patients with IgAN.