Universität zu Köln

Becker, Jan Ulrich, Seron, Daniel, Rabant, Marion ORCID: 0000-0001-5696-6478, Roufosse, Candice and Naesens, Maarten (2022). Evolution of the Definition of Rejection in Kidney Transplantation and Its Use as an Endpoint in Clinical Trials. Transpl. Int., 35. LAUSANNE: FRONTIERS MEDIA SA. ISSN 1432-2277

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Abstract

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 The ongoing use of outdated terminology has become a potential barrier to clinical research in kidney transplantation.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.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Becker, Jan Ulrich UNSPECIFIED UNSPECIFIED UNSPECIFIED Seron, Daniel UNSPECIFIED UNSPECIFIED UNSPECIFIED Rabant, Marion UNSPECIFIED orcid.org/0000-0001-5696-6478 UNSPECIFIED Roufosse, Candice UNSPECIFIED UNSPECIFIED UNSPECIFIED Naesens, Maarten UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-687015
DOI:	10.3389/ti.2022.10141
Journal or Publication Title:	Transpl. Int.
Volume:	35
Date:	2022
Publisher:	FRONTIERS MEDIA SA
Place of Publication:	LAUSANNE
ISSN:	1432-2277
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language ANTIBODY-MEDIATED REJECTION; ALLOGRAFT FAILURE; INFLAMMATION; CLASSIFICATION; BIOPSIES; CRITERIA; AREAS Multiple languages Surgery; Transplantation Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/68701