1. International consensus definitions of clinical trial outcomes for kidney failure: 2020
- Author
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Adrian Liew, David C. Wheeler, Kate Chong, Marvin Sinsakul, Mary Beaucage, Mototsugu Tanaka, Jonathan Barratt, Maarten W. Taal, Aminu K. Bello, Charu Malik, Glenda V. Roberts, Hiddo J.L. Heerspink, Yoshihisa Yamada, Laura Sola, Charlotte Jones-Burton, Thomas F. Hiemstra, Reiko Nakashima, Katherine R. Tuttle, Shuchi Anand, Benjamin O. Wolthers, Jo Ann Donner, Takayuki Hamano, Debasish Banerjee, Rajiv Agarwal, Jennifer B. Rose, Ifeoma Ulasi, Masaomi Nangaku, Duane Sunwold, Vlado Perkovic, NB Argent, Robert Lawatscheck, Vivekanand Jha, Richard Haynes, Dick de Zeeuw, Fergus Caskey, Amer Joseph, Madeleine Warren, Michele Trask, Christoph Wanner, Robert D. Toto, Ian H. de Boer, Kenneth W. Mahaffey, Harold M. Wright, Meg Jardine, Hans Vorster, William Canovatchel, Adeera Levin, Kai-Uwe Eckardt, Marcello Tonelli, Noah L. Rosenberg, Hrefna Gudmundsdottir, Rhys Evans, Agnes B. Fogo, David Harris, Thomas Idorn, Amy R. Sood, Sandrine Damster, A. A. Bernardo, David W. Johnson, Saraladevi Naicker, Julie H. Ishida, William E. Smoyer, Roberto Pecoits Filho, Elena Zakharova, William G. Herrington, Shahnaz Shahinfar, Aliza Thompson, Lesley A. Inker, Matthias Kretzler, Allison Tong, Harold I. Feldman, Louise Moist, Josef Coresh, Elena Babak, Sibylle J. Hauske, Jaime D. Blais, Charles A. Herzog, Uptal D. Patel, Johannes F.E. Mann, Audrey Koitka-Weber, Bénédicte Stengel, Real World Studies in PharmacoEpidemiology, -Genetics, -Economics and -Therapy (PEGET), and Groningen Kidney Center (GKC)
- Subjects
0301 basic medicine ,Nephrology ,medicine.medical_specialty ,END-POINT DEFINITIONS ,medicine.medical_treatment ,21ST-CENTURY ,030232 urology & nephrology ,Renal function ,Disease ,maintenance dialysis ,DISEASE ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Randomized controlled trial ,law ,Internal medicine ,medicine ,CKD ,Intensive care medicine ,Dialysis ,Adjudication ,GFR DECLINE ,business.industry ,continuous kidney replacement therapy ,kidney failure ,Transplantation ,Clinical trial ,030104 developmental biology ,HEART ,business ,NEPHROLOGY ,STROKE ,transplantation - 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.
- Published
- 2020