Seron, Daniel, Rabant, Marion ORCID: 0000-0001-5696-6478, Becker, Jan Ulrich, Roufosse, Candice, Bellini, Maria Irene ORCID: 0000-0003-0730-4923, Boehmig, Georg A., Budde, Klemens ORCID: 0000-0002-7929-5942, Diekmann, Fritz, Glotz, Denis, Hilbrands, Luuk ORCID: 0000-0002-4935-9765, Loupy, Alexandre, Oberbauer, Rainer, Pengel, Liset, Schneeberger, Stefan and Naesens, Maarten (2022). Proposed Definitions of T Cell-Mediated Rejection and Tubulointerstitial Inflammation as Clinical Trial Endpoints in Kidney Transplantation. Transpl. Int., 35. LAUSANNE: FRONTIERS MEDIA SA. ISSN 1432-2277

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Abstract

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.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Seron, DanielUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rabant, MarionUNSPECIFIEDorcid.org/0000-0001-5696-6478UNSPECIFIED
Becker, Jan UlrichUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Roufosse, CandiceUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bellini, Maria IreneUNSPECIFIEDorcid.org/0000-0003-0730-4923UNSPECIFIED
Boehmig, Georg A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Budde, KlemensUNSPECIFIEDorcid.org/0000-0002-7929-5942UNSPECIFIED
Diekmann, FritzUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Glotz, DenisUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hilbrands, LuukUNSPECIFIEDorcid.org/0000-0002-4935-9765UNSPECIFIED
Loupy, AlexandreUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Oberbauer, RainerUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pengel, LisetUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schneeberger, StefanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Naesens, MaartenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-695356
DOI: 10.3389/ti.2022.10135
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:
KeywordsLanguage
RENAL-ALLOGRAFT REJECTION; EXTENDED-RELEASE TACROLIMUS; EARLY PROTOCOL BIOPSIES; TWICE-DAILY TACROLIMUS; MYCOPHENOLATE-MOFETIL; PHASE-III; SUBCLINICAL REJECTION; DOUBLE-BLIND; LONG-TERM; BANFF CLASSIFICATIONMultiple languages
Surgery; TransplantationMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/69535

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