2026-04-17T20:13:10Zhttps://recercat.cat/oai/request

oai:recercat.cat:11351/87772025-10-24T10:17:36Zcom_2072_378070com_2072_378040col_2072_378092

Proposed Definitions of T Cell-Mediated Rejection and Tubulointerstitial Inflammation as Clinical Trial Endpoints in Kidney Transplantation Serón Micas, Daniel Rabant, Marion Becker, Jan Ulrich Roufosse, Candice Bellini, Maria Irene Böhmig, Georg Ronyons - Trasplantació Inflamació Cèl·lules T Rebuig (Biologia) ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Therapeutics::Renal Replacement Therapy::Kidney Transplantation ANATOMY::Cells::Blood Cells::Leukocytes::Leukocytes, Mononuclear::Lymphocytes::T-Lymphocytes PHENOMENA AND PROCESSES::Immune System Phenomena::Transplantation Immunology::Host vs Graft Reaction::Graft Rejection DISEASES::Pathological Conditions, Signs and Symptoms::Pathologic Processes::Inflammation TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::terapéutica::tratamiento de reemplazo renal::trasplante de riñón ANATOMÍA::células::células sanguíneas::leucocitos::leucocitos mononucleares::linfocitos::linfocitos T FENÓMENOS Y PROCESOS::fenómenos del sistema inmunitario::inmunología del trasplante::reacción huésped contra injerto::rechazo del injerto ENFERMEDADES::afecciones patológicas, signos y síntomas::procesos patológicos::inflamación T cell-mediated rejection; Kidney transplantation; Outcomes Rebuig mediat per cèl·lules T; Trasplantament renal; Resultats Rechazo mediado por células T; Trasplante renal; Resultados The diagnosis of acute T cell-mediated rejection (aTCMR) after kidney transplantation has considerable relevance for research purposes. Its definition is primarily based on tubulointerstitial inflammation and has changed little over time; aTCMR is therefore a suitable parameter for longitudinal data comparisons. In addition, because aTCMR is managed with antirejection therapies that carry additional risks, anxieties, and costs, it is a clinically meaningful endpoint for studies. This paper reviews the history and classifications of TCMR and characterizes its potential role in clinical trials: a role that largely depends on the nature of the biopsy taken (indication vs protocol), the level of inflammation observed (e.g., borderline changes vs full TCMR), concomitant chronic lesions (chronic active TCMR), and the therapeutic intervention planned. There is ongoing variability—and ambiguity—in clinical monitoring and management of TCMR. More research, to investigate the clinical relevance of borderline changes (especially in protocol biopsies) and effective therapeutic strategies that improve graft survival rates with minimal patient morbidity, is urgently required. The present paper was developed from documentation produced by the European Society for Organ Transplantation (ESOT) as part of a Broad Scientific Advice request that ESOT submitted to the European Medicines Agency for discussion in 2020. This paper proposes to move toward refined definitions of aTCMR and borderline changes to be included as primary endpoints in clinical trials of kidney transplantation. This initiative was supported by the European Society for Organ Transplantation. 2025-10-24T10:17:36Z 2025-10-24T10:17:36Z 2025-10-24T10:17:36Z 2023-01-09T18:19:02Z 2023-01-09T18:19:02Z 2022-05-20 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion http://hdl.handle.net/11351/8777 Transplant International;35 https://doi.org/10.3389/ti.2022.10135 Attribution 4.0 International http://creativecommons.org/licenses/by/4.0/ info:eu-repo/semantics/openAccess Frontiers Media Scientia