Pipeline News
- FDA Clears Initiation of Phase 2 Efficacy Trial for Ruxoprubart in IgAN: On December 2, 2024, the FDA approved the start of a Phase 2 clinical trial for Ruxoprubart, an anti-Bb monoclonal antibody, targeting IgA nephropathy (IgAN). This drug aims to treat a broad range of renal disorders by selectively blocking the alternative pathway without affecting the classical complement pathway.
- FDA Issues CRL for Sotagliflozin in Type 1 Diabetes and CKD: On December 20, 2024, the FDA issued a Complete Response Letter (CRL) to Lexicon Pharmaceuticals regarding Sotagliflozin (Zynquista) for treating type 1 diabetes with chronic kidney disease (CKD), citing that the benefits do not outweigh the risks.
Kidney Compass Podcast
- Introducing the PARASOL Initiative: The December episode of Kidney Compass featured discussions on the PARASOL initiative, a global project aimed at revolutionizing therapeutic development for rare kidney diseases like FSGS. The episode included insights from Laura Mariani, MD, MS, and Daniel Gale, PhD, MB BChir, focusing on establishing surrogate endpoints for clinical trials.
New Renal Research
- IgAN, FSGS Linked to Greater Kidney Replacement Therapy Risk: Research utilizing data from the Swedish Renal Registry highlighted that patients with IgAN and FSGS are at a higher risk of disease progression requiring kidney replacement therapy compared to other CKD etiologies. Despite a lower risk of hospitalization, cardiovascular events, and death, these patients experience a faster eGFR decline.
- Delta Corticomedullary Apparent Diffusion Coefficient Aids IgAN Risk Stratification: Findings suggest that the corticomedullary difference in apparent diffusion coefficient (ΔADC) is a valuable noninvasive tool for assessing disease activity and stratifying prognostic risk in IgAN patients. ΔADC is significantly associated with eGFR and aids in evaluating kidney interstitial fibrosis severity and predicting 5-year kidney progression risk.
