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Earlier Endpoints Proposed for CKD Trials

Dr. CoreshThe Welch Center’s Josef Coresh, MD, PhD, MHS, chaired the Analytic Group for a NKF/FDA Scientific Workshop, held in Baltimore on December 3rd and 4th. The workshop on “GFR Decline as an Endpoint for Clinical Trials in CKD” recommended earlier surrogate endpoints for clinical trials of chronic kidney disease than have been used to date. The 130 participants in the workshop included clinical trial and epidemiology experts, regulatory representatives from the European Medicines Agency, National Institutes of Health, Critical Path Institute, the FDA; dialysis and pharmaceutical industry representatives; and other professional organizations, including the American Diabetes Association and the Polycystic Kidney Disease Foundation.

A short video on YouTube gives the highlights of the workshop.

      
       

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