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WEBINAR: Risk Stratification and Definition of Acute Rejection for Clinical Trials in Kidney Transplantation

Start Date:
Thursday, July 07th 2022 at 18:00
End Date:
Thursday, July 07th 2022 at 19:00
Description & Objectives:

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.

Target Group:

Transplant nephrologists/surgeons, HLA specialists, renal/transplant pathologists, clinical trial nurses and clinical trialists, transplant researchers, representatives of patients societies and patients advocates, representatives of pharmaceutical companies, health authorities

18:00 – 18:05: Executive summary – Redefining Risk Stratification and Endpoints for Clinical Trials in Kidney Transplantation: Rationale and Methodology of Proposals Submitted to the EMA by ESOT; Maarten Naesens | Leuven, Belgium

18:05 – 18:15: Alloimmune risk stratification for kidney transplant rejection; Olivier Thaunat | Lyon, France

18:15 – 18:25: Evolution of the Definition of Rejection in Kidney Transplantation and Its Use as an Endpoint in Clinical Trials; Jan Ulrich Becker | Cologne, Germany

18:25 – 18:35: Proposed Definitions of T Cell-mediated Rejection and Tubulointerstitial Inflammation as Clinical Trial Endpoints in Kidney Transplantation; Marion Rabant | Paris, France

18:35 – 18:45: Proposed Definitions of Antibody-Mediated Rejection for Use as a Clinical Trial Endpoint in Kidney Transplantation; Candice Roufosse | London, UK

18:45 – 19:00: Q&A and open discussion

Closing remarks: Maria Irene Bellini | Rome, Italy and Maarten Naesens | Leuven, Belgium