Educational Symposium
Proteinuria and eGFR as Clinical Trial End Points in FSGS
November 08, 2025 | 12:45 PM - 01:45 PM
Location: Room TBD2, Hilton Americas-Houston
Session Description
FSGS is a histological pattern of glomerular and podocyte injury with a variable degree of proteinuria and often concomitant nephrotic syndrome at presentation. With an estimated global incidence of 0.8 per 100,000 people per year, FSGS is a rare condition that causes kidney scarring and leads to CKD. Elevated proteinuria, as observed in FSGS, is associated with progression to kidney failure, the need for kidney transplantation, dialysis, and increased mortality. A therapeutic goal in FSGS is to achieve complete remission of proteinuria to prolong kidney function. There are currently no US Food and Drug Administration-approved pharmacologic treatments for FSGS. Thus, there is an urgent need to conduct randomized controlled clinical trials with the aim of developing safe and effective therapies for FSGS.
Support is provided by an educational grant from Travere Therapeutics, Inc.
Learning Objective(s)
- Explain why there is a high burden of FSGS and an urgent need to develop safe and effective therapies for people with FSGS
- Describe the reasonably likely surrogate end point for use in FSGS clinical trials that can enable accelerated approval of novel therapies and expedite access to effective treatments for FSGS
- Discuss the project aimed at advancing the use of proteinuria- and eGFR-based surrogate end points for accelerated and traditional approval of new treatments for FSGS
Learning Pathway(s)
- Glomerular Diseases
- CKD Non-Dialysis
Presentations
- Introduction
12:45 PM - 12:55 PM - Impact of Filtration Barrier Defects in FSGS
12:55 PM - 01:15 PM
- Leveraging Proteinuria and eGFR for Approval of New Treatments for FSGS
01:15 PM - 01:35 PM
- Q&A
01:35 PM - 01:45 PM