Journal article
Proposed definitions of T cell-mediated rejection and tubulointerstitial inflammation as clinical trial endpoints in kidney transplantation
- 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.
- Publication status:
- Published
- Peer review status:
- Peer reviewed
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(Preview, Version of record, 662.5KB, Terms of use)
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- Publisher copy:
- 10.3389/ti.2022.10135
Authors
- Publisher:
- Frontiers Media
- Journal:
- Transplant International More from this journal
- Volume:
- 35
- Article number:
- 10135
- Publication date:
- 2022-05-20
- DOI:
- EISSN:
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1432-2277
- Language:
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English
- Keywords:
- Pubs id:
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1265923
- Local pid:
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pubs:1265923
- Deposit date:
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2022-06-28
Terms of use
- Copyright holder:
- Seron et al.
- Copyright date:
- 2022
- Rights statement:
- ©2022 Seron, Rabant, Becker, Roufosse, Bellini, Böhmig, Budde, Diekmann, Glotz, Hilbrands, Loupy, Oberbauer, Pengel, Schneeberger and Naesens. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
- Licence:
- CC Attribution (CC BY)
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