The PARASOL Initiative and FSGS Management, with Laura Mariani, MD, MS, and Daniel Gale, PhD, MB BChir

In this episode of Kidney Compass: Navigating Clinical Trials, hosts Brendon Neuen, MBBS, PhD, and Shikha Wadhwani, MD, MS, the director of Clinical trials in the Division of Nephrology and the vice chair of Clinical Research in the Department of Medicine at the University of Texas Medical Branch, are joined by Laura Mariani, MD, MS, co-chair of the PARASOL Initiative 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. During the episode, guests take Neuen and Wadhwani on a deep dive into the Proteinuria and GFR as Clinical Trial Endpoints in FSGS (PARASOL) Initiative. An international collaboration launched in 2023, the initiative is aimed at investigating the link between short-term changes in biomarkers, like proteinuria and GFR, and long-term outcomes to support alternative endpoints for drug approval in focal segmental glomerulosclerosis. The video version of this episode is only available on HCPLive.com. Chapters 00:00:00 - Start 00:02:37 - Mariani & Gale Introduction 00:05:03 - Discussing RaDaR Registry Insights 00:09:52 - Challenges and Opportunities in Rare Kidney Disease Research 00:18:44 - PARASOL Initiative Origins 00:25:45- PARASOL Partnership with US FDA  00:35:10 - Key findings from PARASOL 00:46:35 - Proteinuria as a Surrogate Outcome in FSGS 00:53:45 - Applying PARASOL Findings  01:00:30 - Future of PARASOL Initiative Relevant disclosures for Neuen include AstraZeneca, Bayer, Boehringer and Ingelheim, Janssen, and others. Relevant disclosures for Wadhwani include the National Institute of Diabetes and Digestive and Kidney Diseases, GSK, Calliditas and Travere Therapeutics. Relevant disclosures for Mariani include Travere Therapeutics, Boehringer Ingelheim, Reliant Glycosciences, Takeda Pharmaceuticals, HI-Bio, and Calliditas Therapeutics. Relevant disclosures for Gale include Novartis, Alexion, Calliditas, Britannia, Vifor, Judo Bio, Adnovate, Sanofi, Anlylam, Boehringer Ingelheim, and Bayer.