2026-04-14T03:08:38Zhttps://recercat.cat/oai/request

oai:recercat.cat:11351/87762025-10-24T10:44:46Zcom_2072_378070com_2072_378040col_2072_378092

00925njm 22002777a 4500 dc Becker, Jan Ulrich author Serón Micas, Daniel author Rabant, Marion author Roufosse, Candice author Naesens, Maarten author 2023-01-09T18:16:32Z 2023-01-09T18:16:32Z 2022-05-20 T cell-mediated rejection; Biopsy; Subclinical rejection Rechazo mediado por células T; Biopsia; Rechazo subclínico Rebuig mediat per cèl·lules T; Biòpsia; Rebuig subclínic 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 The ongoing use of outdated terminology has become a potential barrier to clinical research in kidney transplantation.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. This initiative was supported by the European Society for Organ Transplantation. http://hdl.handle.net/11351/8776 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