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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
International consensus definitions of clinical trial outcomes for kidney failure: 2020
Kidney International, Volume 98, No. 4, Year 2020
Notification
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Description
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. © 2020 International Society of Nephrology
Authors & Co-Authors
Levin, Adeera I.
Canada, Vancouver
The University of British Columbia
Agarwal, Rajiv L.
United States, Indianapolis
Indiana University School of Medicine
United States, Indianapolis
Richard L. Roudebush Vamc
Heerspink, Hiddo J.Lambers
Netherlands, Groningen
Universitair Medisch Centrum Groningen
Mann, Johannes F.E.
Germany, Erlangen
Friedrich-alexander-universität Erlangen-nürnberg
Germany, Munich
Kfh Kidney Center
Tuttle, Katherine R.
United States, Seattle
University of Washington
Donner, Jo Ann
Belgium, Brussels
International Society of Nephrology
Jha, Vivekanand K.
Australia, Sydney
George Institute for Global Health
India, Manipal
Manipal Academy of Higher Education
Jardine, Meg J.
Australia, Sydney
George Institute for Global Health
Australia, Sydney
Concord Repatriation General Hospital
Mahaffey, Kenneth W.
United States, Stanford
Stanford University School of Medicine
Thompson, Aliza M.
United States, Silver Spring
Food and Drug Administration
Damster, Sandrine
Belgium, Brussels
International Society of Nephrology
Malik, Charu
Belgium, Brussels
International Society of Nephrology
Perkovic, Vlado
Australia, Kensington
Unsw Medicine
Anand, Shuchi
Unknown Affiliation
Banerjee, Debasish
Unknown Affiliation
Bello, Aminu Kasarawa
Unknown Affiliation
Caskey, Fergus J.
Unknown Affiliation
Coresh, Josef
Unknown Affiliation
de Boer, Ian H.
Unknown Affiliation
Eckardt, Kai Uwe
Unknown Affiliation
Fogo, Agnes B.
Unknown Affiliation
Harris, David C.H.
Unknown Affiliation
Herzog, Charles A.
Unknown Affiliation
Inker, Lesley A.
Unknown Affiliation
Johnson, David W.
Unknown Affiliation
Joseph, Amer
Unknown Affiliation
Kretzler, Matthias
Unknown Affiliation
Liew, Seng Teck Adrian
Unknown Affiliation
Moist, Louise M.
Unknown Affiliation
Naicker, Saraladevi
Unknown Affiliation
Patel, Uptal D.
Unknown Affiliation
Pecoits-Filho, Roberto
Unknown Affiliation
Smoyer, William E.
Unknown Affiliation
Solá, Laura
Unknown Affiliation
Stengel, Brian Né Dicte
Unknown Affiliation
Taal, Maarten W.
Unknown Affiliation
Tonelli, Marcello A.
Unknown Affiliation
Tong, Allison
Unknown Affiliation
Trask, Michele Anne
Unknown Affiliation
Ulasi, Ifeoma I.
Unknown Affiliation
Wanner, Christoph
Unknown Affiliation
Wheeler, David Collins
Unknown Affiliation
Zakharova, Elena V.
Unknown Affiliation
Statistics
Citations: 58
Authors: 43
Affiliations: 17
Identifiers
Doi:
10.1016/j.kint.2020.07.013
ISSN:
00852538
Research Areas
Health System And Policy
Noncommunicable Diseases