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Evolution of the Definition of Rejection in Kidney Transplantation and Its Use as an Endpoint in Clinical Trials

This article outlines the evolving definition of rejection following kidney transplantation. The viewpoints and evidence presented were included in documentation prepared for a Broad Scientific Advice request to the European Medicines Agency (EMA), relating to clinical trial endpoints in kidney tran...

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Autores principales: Becker, Jan Ulrich, Seron, Daniel, Rabant, Marion, Roufosse, Candice, Naesens, Maarten
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9163319/
https://www.ncbi.nlm.nih.gov/pubmed/35669978
http://dx.doi.org/10.3389/ti.2022.10141
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author Becker, Jan Ulrich
Seron, Daniel
Rabant, Marion
Roufosse, Candice
Naesens, Maarten
author_facet Becker, Jan Ulrich
Seron, Daniel
Rabant, Marion
Roufosse, Candice
Naesens, Maarten
author_sort Becker, Jan Ulrich
collection PubMed
description This article outlines the evolving definition of rejection following kidney transplantation. The viewpoints and evidence presented were included in documentation prepared for a Broad Scientific Advice request to the European Medicines Agency (EMA), relating to clinical trial endpoints in kidney transplantation. This request was initiated by the European Society for Organ Transplantation (ESOT) in 2016 and finalized following discussions between the EMA and ESOT in 2020. In ESOT’s opinion, the use of “biopsy-proven acute rejection” as an endpoint for clinical trials in kidney transplantation is no longer accurate, although it is still the approved histopathological endpoint. The spectrum of rejection is now divided into the phenotypes of borderline changes, T cell-mediated rejection, and antibody-mediated rejection, with the latter two phenotypes having further subclassifications. Rejection is also described in relation to graft (dys)function, diagnosed because of protocol (surveillance) or indication (for-cause) biopsies. The ongoing use of outdated terminology has become a potential barrier to clinical research in kidney transplantation. This article presents these perspectives and issues, and provides a foundation on which subsequent articles within this Special Issue of Transplant International build.
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spelling pubmed-91633192022-06-05 Evolution of the Definition of Rejection in Kidney Transplantation and Its Use as an Endpoint in Clinical Trials Becker, Jan Ulrich Seron, Daniel Rabant, Marion Roufosse, Candice Naesens, Maarten Transpl Int Health Archive This article outlines the evolving definition of rejection following kidney transplantation. The viewpoints and evidence presented were included in documentation prepared for a Broad Scientific Advice request to the European Medicines Agency (EMA), relating to clinical trial endpoints in kidney transplantation. This request was initiated by the European Society for Organ Transplantation (ESOT) in 2016 and finalized following discussions between the EMA and ESOT in 2020. In ESOT’s opinion, the use of “biopsy-proven acute rejection” as an endpoint for clinical trials in kidney transplantation is no longer accurate, although it is still the approved histopathological endpoint. The spectrum of rejection is now divided into the phenotypes of borderline changes, T cell-mediated rejection, and antibody-mediated rejection, with the latter two phenotypes having further subclassifications. Rejection is also described in relation to graft (dys)function, diagnosed because of protocol (surveillance) or indication (for-cause) biopsies. The ongoing use of outdated terminology has become a potential barrier to clinical research in kidney transplantation. This article presents these perspectives and issues, and provides a foundation on which subsequent articles within this Special Issue of Transplant International build. Frontiers Media S.A. 2022-05-20 /pmc/articles/PMC9163319/ /pubmed/35669978 http://dx.doi.org/10.3389/ti.2022.10141 Text en Copyright © 2022 Becker, Seron, Rabant, Roufosse and Naesens. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Health Archive
Becker, Jan Ulrich
Seron, Daniel
Rabant, Marion
Roufosse, Candice
Naesens, Maarten
Evolution of the Definition of Rejection in Kidney Transplantation and Its Use as an Endpoint in Clinical Trials
title Evolution of the Definition of Rejection in Kidney Transplantation and Its Use as an Endpoint in Clinical Trials
title_full Evolution of the Definition of Rejection in Kidney Transplantation and Its Use as an Endpoint in Clinical Trials
title_fullStr Evolution of the Definition of Rejection in Kidney Transplantation and Its Use as an Endpoint in Clinical Trials
title_full_unstemmed Evolution of the Definition of Rejection in Kidney Transplantation and Its Use as an Endpoint in Clinical Trials
title_short Evolution of the Definition of Rejection in Kidney Transplantation and Its Use as an Endpoint in Clinical Trials
title_sort evolution of the definition of rejection in kidney transplantation and its use as an endpoint in clinical trials
topic Health Archive
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9163319/
https://www.ncbi.nlm.nih.gov/pubmed/35669978
http://dx.doi.org/10.3389/ti.2022.10141
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