NEW YORK—The U.S. Food and Drug Administration (FDA) is now considering new endpoints for clinical trials in chronic kidney disease (CKD) patients as a result of a special scientific workshop convened by the National Kidney Foundation (NKF) and the FDA on December 3-4 in Baltimore. After extensive analysis of data from observational cohorts and interventional trials, the workshop planning committee and attendees recommended a 30 or 40 percent decline in glomerular filtration rate (GFR) as new surrogate endpoints for some clinical trials in chronic kidney disease used for regulatory approval.
“While the results will take some time to explore and understand fully, they will provide a firm basis for establishing reasonable end points for studies in chronic kidney disease in the near term. More importantly, the cooperation among regulators, NKF, and academic researchers and the analytical methods developed here should serve as a model to address similar issues in the future,” said Norman Stockbridge, MD, PhD, Division Director, Cardiovascular and Renal Products, FDA.
CKD affects 26 million Americans and is a significant public health problem in the U.S., yet its progression is slow and CKD is often asymptomatic until it reaches kidney failure.
“Efficiently testing drugs to slow the progression of CKD has been a major challenge, since the beneficial effects of treatment don’t manifest in patients for many years,” said workshop co-chair Andrew Levey, MD, Professor of Medicine, Tufts Medical Center.
Prior to this workshop, halving of GFR, assessed as a doubling of serum creatinine levels, was considered an acceptable surrogate endpoint for the development of kidney failure.
“Yet while doubling of serum creatinine is predictive of kidney failure, even this takes a long time to develop. That’s why NKF collaborated with the FDA on this initiative to identify alternative endpoints that could potentially shorten the duration of clinical trials and extend their application to the early stages,” said Levey.
The NKF/FDA Scientific Workshop, “GFR Decline as an Endpoint for Clinical Trials in CKD” was the result of the year-long efforts of a Planning Committee chaired by Dr. Andrew Levey and Dr. Aliza Thompson of the FDA, and Dr. Josef Coresh, Chair of the Analytic Group. The 130 workshop attendees 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.
For more information, visit www.kidney.org