Endpoints and Trial Designs to Advance Drug Development in Kidney Transplantation NOVEMBER 9, 2023

https://www.fda.gov/drugs/news-events-human-drugs/endpoints-and-trial-designs-advance-drug-development-kidney-transplantation-11092023?utm_medium=email&utm_source=govdelivery This week, FDA, in co-sponsorship with the University of Manitoba, announced the public workshop “Endpoints and Trial Designs to Advance Drug Development in Kidney Transplantation.” The purpose of this workshop is to stimulate discussion among FDA, academicians, and industry on endpoint and trial design to promote developing safe and effective medications without long term side effects for kidney transplantation, which is an area of unmet need. The topics of discussion regarding efficacy endpoints for prophylaxis of kidney transplant rejection trials include: The current state of primary endpoints and future potential endpoints; Biopsy-proven acute rejection (BPAR) efficacy failure; Non-inferiority trials; and, Enrichment as a tool in trial design. The workshop will be held Thursday, November 9 from 8:00 am – 4:30 pm ET both on-site at the FDA’s White Oak Campus (Silver Spring, MD) and virtually.