2026-04-17T00:36:14Zhttps://recercat.cat/oai/requestoai:recercat.cat:11351/87762025-10-24T10:44:46Zcom_2072_378070com_2072_378040col_2072_378092
RECERCAT
author
Becker, Jan Ulrich
author
Serón Micas, Daniel
author
Rabant, Marion
author
Roufosse, Candice
author
Naesens, Maarten
2025-10-24T10:44:46Z
2025-10-24T10:44:46Z
2023-01-09T18:16:32Z2023-01-09T18:16:32Z2022-05-20
http://hdl.handle.net/11351/8776
T cell-mediated rejection; Biopsy; Subclinical rejectionRechazo mediado por células T; Biopsia; Rechazo subclínicoRebuig mediat per cèl·lules T; Biòpsia; Rebuig subclínicThis 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 The ongoing use of outdated terminology has become a potential barrier to clinical research in kidney transplantation.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.This initiative was supported by the European Society for Organ Transplantation.
Attribution 4.0 International http://creativecommons.org/licenses/by/4.0/ info:eu-repo/semantics/openAccess
Ronyons - Trasplantació
Immunoglobulines
Rebuig (Biologia)
ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Renal Replacement Therapy::Kidney Transplantation
PHENOMENA AND PROCESSES::Immune System Phenomena::Transplantation Immunology::Host vs Graft Reaction::Graft Rejection
CHEMICALS AND DRUGS::Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies
TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::tratamiento de reemplazo renal::trasplante de riñón
FENÓMENOS Y PROCESOS::fenómenos del sistema inmunitario::inmunología del trasplante::reacción huésped contra injerto::rechazo del injerto
COMPUESTOS QUÍMICOS Y DROGAS::aminoácidos, péptidos y proteínas::proteínas::proteínas sanguíneas::inmunoproteínas::inmunoglobulinas::anticuerpos
Evolution of the Definition of Rejection in Kidney Transplantation and Its Use as an Endpoint in Clinical Trials
info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion