Nephrology Month in Review: December 2024

In a fitting conclusion to what was a busy year for the field of nephrology, December saw a plethora of renal news, research, and advancements to close out 2024 and usher in 2025. The month was characterized by IgA nephropathy (IgAN) and chronic kidney disease (CKD) news from the US Food and Drug Administration, a new episode of Kidney Compass: Navigating Clinical Trials about focal segmental glomerulosclerosis (FSGS) drug development, and new research about risk stratification in IgAN, all of which we spotlight in this December 2024 month in review.

Pipeline News

FDA Clears Initiation of Phase 2 Efficacy Trial for Ruxoprubart in IgAN

On December 2, 2024, the FDA cleared the initiation of a phase 2 efficacy clinical trial to evaluate the investigational new drug (IND) ruxoprubart for the treatment of IgAN.

An anti-Bb monoclonal antibody, ruxoprubart selectively blocks the initiation and distribution of the alternative pathway. By blocking the dysregulation of this pathway while avoiding the classical complement pathway, ruxoprubart is thought to be able to effectively treat a broad range of renal disorders.

“We are excited to announce the Phase 2 IND approval for IgAN, alongside atypical hemolytic uremic syndrome (aHUS) and antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis (AAV), where Ruxoprubart will play a pivotal role in the treatment of chronic kidney conditions,” Rekha Bansal, chief executive officer of NovelMed, announced in a statement. “This clearance marks a significant milestone for Ruxoprubart, not only for IgAN but also as a platform therapy for multiple indications.”

FDA Issues CRL for Sotagliflozin in Type 1 Diabetes and CKD

In less positive renal FDA news, on December 20, 2024, the FDA issued a Complete Response Letter (CRL) to Lexicon Pharmaceuticals for sotagliflozin (Zynquista) and their supplemental New Drug Application for treatment of type 1 diabetes with CKD.

The CRL for the SGLT1/2, which received approval for heart failure and is marketed under the brand name Inpefa, comes less than 2 months after the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 11 to 3 that the benefits of the agent do not outweigh the risks among adult patients with type 1 diabetes and CKD.

Kidney Compass Podcast

Kidney Compass: Introducing the PARASOL Initiative, with Laura Mariani, MD, MS, and Daniel Gale, PhD, MB BChir

December saw the launch of yet another episode of Kidney Compass: Navigating Clinical Trials, a nephrology podcast created by Brendon Neuen, MBBS, PhD, and Shikha Wadhwani, MD, MS, and hosted on HCPLive. In this episode, the hosts are joined by guests PARASOL co-chair Laura Mariani, MD, MS, an associate professor in the division of nephrology at the University of Michigan, and Daniel Gale, PhD, MB BChir, director of the UK-based RaDaR Registry and the St Peter's Chair of Nephrology at University College London.

In the 4-part episode, the experts discuss the PARASOL initiative—a global project revolutionizing therapeutic development for rare kidney diseases like FSGS with efforts to establish surrogate endpoints for clinical trials.

New Renal Research

IgAN, FSGS Linked to Greater Kidney Replacement Therapy Risk Than Common CKD Etiologies

New research points to an increased risk of disease progression requiring kidney replacement therapy in patients with IgAN and FSGS relative to those with other common CKD etiologies. Leveraging data from the Swedish Renal Registry, the study found patients with IgAN and FSGS had a reduced risk of hospitalization, cardiovascular events, and death, but had a faster eGFR decline and were more likely to require kidney replacement therapy than patients with membranous nephropathy, minimal change disease, and CKD due to the most common non-communicable diseases.

Delta Corticomedullary Apparent Diffusion Coefficient Aids IgAN Risk Stratification

The corticomedullary difference in apparent diffusion coefficient (ΔADC) may be a valuable noninvasive tool for complementarily assessing disease activity and stratifying prognostic risk in patients with IgAN, according to findings from this study, which support the role of ΔADC in assessing the clinical, pathological, and prognostic risk stratification of patients with IgAN. Of note, in addition to being significantly associated with eGFR, ΔADC enabled a reliable evaluation of kidney interstitial fibrosis severity and facilitated accurate 5-year kidney progression risk prediction.