Nephrology Month in Review: April 2025

The nephrology landscape saw meaningful developments in April, from US Food and Drug Administration action on glomerular diseases to studies highlighting ongoing challenges in chronic kidney disease (CKD) and inequities in renal care.

In FDA news, the agency accepted a supplemental New Drug Application (sNDA) for pegcetacoplan (Empaveli) in C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN), as well as the accelerated approval of atrasentan (Vanrafia) for proteinuria reduction in IgA nephropathy (IgAN).

Meanwhile, new studies underscored the long-term renal consequences of COVID-19, the growing CKD burden tied to low physical activity, and the prevalence of CKD among individuals with prediabetes. On the health equity front, research revealed disparities in access to preemptive transplant and high-quality dialysis, with socioeconomic and racial inequities playing a key role in care quality.

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

Renal Regulatory Updates

FDA Accepts Pegcetacoplan (Empaveli) sNDA for C3G, IC-MPGN

Starting the month off on a high note, on April 1, 2025, Apellis Pharmaceuticals announced that the FDA had accepted and granted Priority Review designation to the sNDA for pegcetacoplan (Empaveli) for C3G and IC-MPGN, setting a Prescription Drug User Fee Act (PDUFA) target action date of July 28, 2025.

Atrasentan (Vanrafia) Receives Accelerated Approval in IgA Nephropathy

The next day, on April 2, 2025, the FDA granted accelerated approval to atrasentan (Vanrafia), a once-daily, non-steroidal, oral treatment, for reducing proteinuria in adults with primary IgAN at risk of rapid disease progression.

“Today’s approval marks an important milestone for people living with IgA nephropathy, offering a new option that can be seamlessly integrated into their existing treatment plan, with no REMS requirement,” said Richard Lafayette, MD, professor of medicine in nephrology and director of the Glomerular Disease Center at Stanford University Medical Center, and Vanrafia ALIGN Study Investigator and Steering Committee Member. “Vanrafia is a selective ETA receptor antagonist that effectively reduces proteinuria, a major risk factor in IgAN. Taking early, decisive action is critical to help improve outcomes for these patients who too often progress toward kidney failure.”

Understanding CKD Risks

COVID-19 Infection Increases Risk of Advanced CKD, Long-Term Renal Dysfunction

Leveraging data from the TriNetX Healthcare Commercial Organizations database for nearly 300,000 adult patients diagnosed with COVID-19 or influenza, this matched cohort study found individuals with COVID-19 had a greater risk of new-onset advanced CKD and long-term renal dysfunction than those with influenza.

Study Highlights Growing Burden of CKD Attributable to Low Physical Activity

The burden of CKD attributable to physical inactivity increased significantly from 1990-2021, according to results from this study, which found that despite some regional declines in mortality rates, global CKD-related deaths and disability-adjusted life years have risen significantly, especially in low-sociodemographic index regions, among older adults, and in females.

CKD Common in Patients with Prediabetes, Especially with Hypertension or ASCVD

An analysis of data from the the Providence- and University of California Los Angeles Health-based Kidney Disease Research, Education, and Hope (CURE-CKD) Registry highlights frequent rapid-onset CKD in patients with prediabetes, especially in the presence of hypertension or atherosclerotic cardiovascular disease.

Social Determinants of Health in Nephrology

Socioeconomic Status Impacts Pediatric Preemptive Kidney Transplant Rates, Study Finds

Findings from this retrospective cohort study of pediatric patients who received a kidney transplant at the University of Minnesota highlight significant socioeconomic disparities in preemptive kidney transplantation rates in this patient population. Specifically, lower HOUsing-based index of Socio-Economic Status (HOUSES) index quartile was associated with significantly reduced odds of preemptive transplantation.

Study Suggests Racial Disparities in Access to High-Quality Dialysis Facilities

New research is providing clinicians with an overview of how care continuity with a predialysis nephrologist impacts end-stage kidney disease (ESKD) patients’ dialysis start quality, with study findings suggesting most patients with ESKD are likely to initiate dialysis at their predialysis nephrologists’ primary facility, even if it has a poor rating through the Centers for Medicare and Medicaid Services Dialysis Facility Compare Star Program. Of note, Black patients more frequently saw nephrologists with low-quality primary facilities and in turn received lower quality dialysis care.