International consensus definitions of clinical trial outcomes for kidney failure: 2020
Adeera Levin, Rajiv Agarwal, William G Herrington, Hiddo L Heerspink, Johannes F E Mann, Shahnaz Shahinfar, Katherine R Tuttle, Jo-Ann Donner, Vivekanand Jha, Masaomi Nangaku, Dick de Zeeuw, Meg J Jardine, Kenneth W Mahaffey, Aliza M Thompson, Mary Beaucage, Kate Chong, Glenda V Roberts, Duane Sunwold, Hans Vorster, Madeleine Warren, Sandrine Damster, Charu Malik, Vlado Perkovic, participant authors of the International Society of Nephrology’s 1st International Consensus Meeting on Defining Kidney Failure in Clinical Trials, Shuchi Anand, Nicholas Argent, Elena Babak, Debasish Banerjee, Jonathan Barratt, Aminu K Bello, Angelito A Bernardo, Jaime Blais, William Canovatchel, Fergus J Caskey, Josef Coresh, Ian H de Boer, Kai-Uwe Eckardt, Rhys Dr Evans, Harold I Feldman, Agnes B Fogo, Hrefna Gudmundsdottir, Takayuki Hamano, David C H Harris, Sibylle J Hauske, Richard Haynes, Charles A Herzog, Thomas Hiemstra, Thomas Idorn, Lesley Inker, Julie H Ishida, David W Johnson, Charlotte Jones-Burton, Amer Joseph, Audrey Koitka-Weber, Matthias Kretzler, Robert Lawatscheck, Adrian Liew, Louise Moist, Saraladevi Naicker, Reiko Nakashima, Uptal Patel, Roberto Pecoits Filho, Jennifer B Rose, Noah L Rosenberg, Marvin Sinsakul, William E Smoyer, Laura Sola, Amy R Sood, Benedicte Stengel, Maarten W Taal, Mototsugu Tanaka, Marcello Tonelli, Allison Tong, Robert Toto, Michele Trask, Ifeoma I Ulasi, Christoph Wanner, David C Wheeler, Benjamin O Wolthers, Harold M Wright, Yoshihisa Yamada, Elena Zakharova, Adeera Levin, Rajiv Agarwal, William G Herrington, Hiddo L Heerspink, Johannes F E Mann, Shahnaz Shahinfar, Katherine R Tuttle, Jo-Ann Donner, Vivekanand Jha, Masaomi Nangaku, Dick de Zeeuw, Meg J Jardine, Kenneth W Mahaffey, Aliza M Thompson, Mary Beaucage, Kate Chong, Glenda V Roberts, Duane Sunwold, Hans Vorster, Madeleine Warren, Sandrine Damster, Charu Malik, Vlado Perkovic, participant authors of the International Society of Nephrology’s 1st International Consensus Meeting on Defining Kidney Failure in Clinical Trials, Shuchi Anand, Nicholas Argent, Elena Babak, Debasish Banerjee, Jonathan Barratt, Aminu K Bello, Angelito A Bernardo, Jaime Blais, William Canovatchel, Fergus J Caskey, Josef Coresh, Ian H de Boer, Kai-Uwe Eckardt, Rhys Dr Evans, Harold I Feldman, Agnes B Fogo, Hrefna Gudmundsdottir, Takayuki Hamano, David C H Harris, Sibylle J Hauske, Richard Haynes, Charles A Herzog, Thomas Hiemstra, Thomas Idorn, Lesley Inker, Julie H Ishida, David W Johnson, Charlotte Jones-Burton, Amer Joseph, Audrey Koitka-Weber, Matthias Kretzler, Robert Lawatscheck, Adrian Liew, Louise Moist, Saraladevi Naicker, Reiko Nakashima, Uptal Patel, Roberto Pecoits Filho, Jennifer B Rose, Noah L Rosenberg, Marvin Sinsakul, William E Smoyer, Laura Sola, Amy R Sood, Benedicte Stengel, Maarten W Taal, Mototsugu Tanaka, Marcello Tonelli, Allison Tong, Robert Toto, Michele Trask, Ifeoma I Ulasi, Christoph Wanner, David C Wheeler, Benjamin O Wolthers, Harold M Wright, Yoshihisa Yamada, Elena Zakharova
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.
Keywords: continuous kidney replacement therapy; kidney failure; maintenance dialysis; transplantation.
Copyright © 2020 International Society of Nephrology. All rights reserved.
Source: PubMed