FDA Perspective on the Evolution of Acceptable Endpoints for Both Broad & Specialized CKD

Time: 8:00 am
day: Conference Day 1


  • 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