학술논문
International consensus definitions of clinical trial outcomes for kidney failure: 2020
Document Type
Article
Author
Levin, Adeera; Agarwal, Rajiv; Herrington, William G.; Heerspink, Hiddo L.; Mann, Johannes F.E.; Shahinfar, Shahnaz; Tuttle, Katherine R.; Donner, Jo-Ann; Jha, Vivekanand; Nangaku, Masaomi; de Zeeuw, Dick; Jardine, Meg J.; Mahaffey, Kenneth W.; Thompson, Aliza M.; Beaucage, Mary; Chong, Kate; Roberts, Glenda V.; Sunwold, Duane; Vorster, Hans; Warren, Madeleine; Damster, Sandrine; Malik, Charu; Perkovic, Vlado; Anand, Shuchi; Argent, Nicholas; Babak, Elena; Banerjee, Debasish; Barratt, Jonathan; Bello, Aminu K.; Bernardo, Angelito A.; Blais, Jaime; Canovatchel, William; Caskey, Fergus J.; Coresh, Josef; de Boer, Ian H.; Eckardt, Kai-Uwe; Evans, Rhys DR.; Feldman, Harold I.; Fogo, Agnes B.; Gudmundsdottir, Hrefna; Hamano, Takayuki; Harris, David C.H.; Hauske, Sibylle J.; Haynes, Richard; Herzog, Charles A.; Hiemstra, Thomas; Idorn, Thomas; Inker, Lesley; Ishida, Julie H.; Johnson, David W.; Jones-Burton, Charlotte; Joseph, Amer; Koitka-Weber, Audrey; Kretzler, Matthias; Lawatscheck, Robert; Liew, Adrian; Moist, Louise; Naicker, Saraladevi; Nakashima, Reiko; Patel, Uptal; Filho, Roberto Pecoits; Rose, Jennifer B.; Rosenberg, Noah L.; Sinsakul, Marvin; Smoyer, William E.; Sola, Laura; Sood, Amy R.; Stengel, Benedicte; Taal, Maarten W.; Tanaka, Mototsugu; Tonelli, Marcello; Tong, Allison; Toto, Robert; Trask, Michele; Ulasi, Ifeoma I.; Wanner, Christoph; Wheeler, David C.; Wolthers, Benjamin O.; Wright, Harold M.; Yamada, Yoshihisa; Zakharova, Elena
Source
Kidney International; October 2020, Vol. 98 Issue: 4 p849-859, 11p
Subject
Language
ISSN
00852538; 15231755
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.