KHI Workgroup Opportunity
Surrogate Endpoints in FSGS
Overview
Despite being associated with a relatively rapid decline in kidney function, there are no approved drugs and no accepted endpoints for registration of investigational products for FSGS. The focus of this project was to identify surrogate endpoints for use in clinical trials in FSGS patients, by reviewing published literature and analyzing data from cohorts/completed trials to identify candidate surrogates for endpoints, identifying risk factors for progression, critically assessing the candidate measures, and identifying gaps in the data. A Kidney Health Initiative working group sought to identify potential short-term and intermediate candidate surrogate outcome measures by performing a critical review of the literature in FSGS, focused on prospective cohort studies and prospective interventional clinical trials; and analyzing data from available FSGS databases.