Risk Stratification and Definition of Acute Rejection for Clinical Trials in Kidney Transplantation
This is the first of two webinars dedicated to presenting and discussing the articles included in the supplement published on Transplant International – Special Issue “Clinical trial design and endpoints in kidney transplantation
”. The supplement provides a detailed summary of key aspects of the proposals and recommendations for definitions of endpoints for clinical trials of kidney transplantation.
In the supplement, a panel of European experts redefines the immune risk stratification and endpoints for clinical trials in kidney transplantation. Both the rationale and proposals for established (rejection, graft function) and newer endpoints (including surrogate endpoints and patient-reported outcomes) are presented, as well as the responses from the European Medicines Agency (EMA) on these proposals. This Special Issue will serve as a guide for the design of future clinical trials aiming at improving outcome after kidney transplantation.