Journal article
Allograft function as endpoint for clinical trials in kidney transplantation
- Abstract:
- Clinical study endpoints that assess the efficacy of interventions in patients with chronic renal insufficiency can be adopted for use in kidney transplantation trials, given the pathophysiological similarities between both conditions. Kidney dysfunction is reflected in the glomerular filtration rate (GFR), and although a predefined (e.g., 50%) reduction in GFR was recommended as an endpoint by the European Medicines Agency (EMA) in 2016, many other endpoints are also included in clinical trials. End-stage renal disease is strongly associated with a change in estimated (e)GFR, and eGFR trajectories or slopes are increasingly used as endpoints in clinical intervention trials in chronic kidney disease (CKD). Similar approaches could be considered for clinical trials in kidney transplantation, although several factors should be taken into account. The present Consensus Report 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 EMA in 2020. This paper provides a contemporary discussion of primary endpoints used in clinical trials involving CKD, including proteinuria and albuminuria, and evaluates the validity of these concepts as endpoints for clinical trials in kidney transplantation.
- Publication status:
- Published
- Peer review status:
- Peer reviewed
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(Preview, Version of record, 663.7KB, Terms of use)
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- Publisher copy:
- 10.3389/ti.2022.10139
Authors
- Publisher:
- Frontiers Media
- Journal:
- Transplant International More from this journal
- Volume:
- 35
- Article number:
- 10139
- Publication date:
- 2022-05-20
- Acceptance date:
- 2022-01-11
- DOI:
- EISSN:
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1432-2277
- ISSN:
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0934-0874
- Language:
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English
- Keywords:
- Pubs id:
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1231541
- Local pid:
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pubs:1231541
- Deposit date:
-
2022-01-11
Terms of use
- Copyright holder:
- Hilbrands et al.
- Copyright date:
- 2022
- Rights statement:
- ©2022 Hilbrands, Budde, Bellini, Diekmann, Furian, Grinyó, Heemann, Hesselink, Loupy, Oberbauer, Pengel, Reinders, 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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