Surrogate Endpoints for Clinical Trials in Kidney Transplantation; Public Workshop
The Food and Drug Administration (FDA) is announcing a public workshop to discuss potential surrogate endpoints for clinical trials of drugs and therapeutic biologics in kidney transplantation, with a focus on endpoints in conditions that represent unmet medical needs. This public workshop is intended to provide information and gain perspective from health care providers, academia, and industry on the role of various laboratories, histologic, and other endpoints used to evaluate patient and allograft outcome in clinical trials of kidney transplantation. The meeting will include discussion of allograft histology and biomarkers, laboratory measures of outcome, and other endpoints that may serve as surrogates for patient and graft morbidity and survival. Related topics for discussion will include clinically-relevant risk factors and prognostic factors in the kidney transplant population. Patient selection and enrichment strategies (inclusion/exclusion criteria) will be considered. The input from this public workshop will help in developing topics for further discussion and may serve to inform recommendations on potential surrogate endpoints in clinical trials of kidney transplantation.