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International consensus definitions of clinical trial outcomes for kidney failure: 2020

Levin, A; Agarwal, R; Herrington, WG; Heerspink, HL; Mann, JFE; Shahinfar, S; Tuttle, KR; ... participant authors of the International Society of Nephrology’s; + view all (2020) International consensus definitions of clinical trial outcomes for kidney failure: 2020. Kidney International , 98 (4) pp. 849-859. 10.1016/j.kint.2020.07.013. Green open access

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Abstract

Kidney failure is an important outcome for patients, clinicians, researchers, healthcare systems, payers, and regulators. However, no harmonized international consensus definitions of kidney failure and key surrogates of progression to kidney failure exist specifically for clinical trials. The International Society of Nephrology convened an international multi-stakeholder meeting to develop consensus on this topic. A core group, experienced in design, conduct, and outcome adjudication of clinical trials, developed a database of 64 randomized trials and the 163 included definitions relevant to kidney failure. Using an iterative process, a set of proposed consensus definitions were developed and subsequently vetted by the larger multi-stakeholder group of 83 participants representing 18 different countries. The consensus of the meeting participants was that clinical trial kidney failure outcomes should be comprised of a composite that includes receipt of a kidney transplant, initiation of maintenance dialysis, and death from kidney failure; it may also include outcomes based solely on laboratory measurements of glomerular filtration rate: a sustained low glomerular filtration rate and a sustained percent decline in glomerular filtration rate. Discussion included important considerations, such as (i) recognition of existing nomenclature for kidney failure; (ii) applicability across resource settings; (iii) ease of understanding for all stakeholders; and (iv) avoidance of inappropriate complexity so that the definitions can be used across ranges of populations and trial methodologies. The final definitions reflect the consensus for use in clinical trials.

Type: Article
Title: International consensus definitions of clinical trial outcomes for kidney failure: 2020
Location: United States
Open access status: An open access version is available from UCL Discovery
DOI: 10.1016/j.kint.2020.07.013
Publisher version: https://doi.org/10.1016/j.kint.2020.07.013
Language: English
Additional information: This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
Keywords: continuous kidney replacement therapy, kidney failure, maintenance dialysis, transplantation, Consensus, Delphi Technique, Humans, Renal Insufficiency, Research Design, Treatment Outcome
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Medical Sciences > Div of Medicine > Renal Medicine
URI: https://discovery.ucl.ac.uk/id/eprint/10140502
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