PARASOL Project Advances Understanding of Proteinuria in FSGS

BETHESDA, Md. October 14, 2024 – A multi-stakeholder group of rare kidney disease experts aligned around a potential proteinuria-based clinical trial endpoint, balancing biological relevance and trial design considerations.

PARASOL (Proteinuria and GFR as Clinical Trial Endpoints in Focal Segmental Glomerulosclerosis [FSGS]), an initiative co-sponsored by NephCure, the International Society of Glomerular Disease, the U.S. Food and Drug Administration, the Kidney Health Initiative, and the National Kidney Foundation, convened for the third time in the past ten months at a public scientific workshop held in Bethesda, Maryland on October 7-8, 2024. FSGS is an important cause of kidney failure in patients of all ages and new therapies are urgently needed to reduce the risk of progression. The objective of PARASOL is to advance the understanding and use of proteinuria and eGFR-based surrogate endpoints for accelerated and traditional approval of new treatments for FSGS, thus facilitating the development of new therapies. PARASOL represents the collaborative effort of nephrologists, scientists, patient advocates, biostatisticians, trial sponsors, and regulatory authorities.