Endpoints for Clinical Trials in Kidney Transplantation; Public Workshop
The Food and Drug Administration (FDA) is announcing a public workshop to discuss the endpoints for clinical trials of drugs and therapeutic biologic products in kidney transplantation. This public workshop is intended to obtain information and gain perspective from health care providers, academia, and industry on the role of various endpoints used to evaluate patient and allograft outcome in clinical trials of kidney transplantation. The meeting will include a discussion of patient and graft survival, evaluation of the allograft via histology and biomarkers, glomerular filtration rate or other measures of renal function, evaluation of safety, and other topics. The input from this public workshop will help in developing topics for further discussion and may serve to inform recommendations on potential endpoints in clinical trials of kidney transplantation.
Dates and Times: The public workshop will be held on September 10, 2012 from 9:00 am to 6:00 pm and on September 11, 2012 from 8:00 am to 3:00 pm.
Location: Sheraton Silver Spring Hotel, 8777 Georgia Ave., Silver Spring, MD 20910
- Federal Register Notice
- Agenda (PDF - 45KB)
- Transcript: Monday, September 10, 2012 (PDF - 8MB)
- Transcript: Tuesday, September 11, 2012 (PDF - 8MB)