FDA Perspective on the Evolution of Acceptable Endpoints for Both Broad & Specialized CKD
Time: 8:00 am
day: Conference Day 1
Details:
- Looking beyond IgA Nephropathy for considerations of other accelerated approval paths that might be open to investigation using surrogate endpoints
- Navigating the differential relationship between proteinuria and eGFR across different indications, which poses a challenge when establishing proteinuria as a surrogate in other diseases
- Determining prerequisites for utilizing GFR decline for CKD studies in general as an endpoint
