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

doi:10.1016/j.kint.2020.07.013

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

Kidney Int. 2020 Oct;98(4):849-859. doi: 10.1016/j.kint.2020.07.013.

Authors

Adeera Levin¹, Rajiv Agarwal², William G Herrington³, Hiddo L Heerspink⁴, Johannes F E Mann⁵, Shahnaz Shahinfar⁶, Katherine R Tuttle⁷, Jo-Ann Donner⁸, Vivekanand Jha⁹, Masaomi Nangaku¹⁰, Dick de Zeeuw⁴, Meg J Jardine¹¹, Kenneth W Mahaffey¹², Aliza M Thompson¹³, Mary Beaucage¹⁴, Kate Chong¹⁵, Glenda V Roberts¹⁶, Duane Sunwold¹⁷, Hans Vorster¹⁸, Madeleine Warren¹⁹, Sandrine Damster⁸, Charu Malik⁸, Vlado Perkovic²⁰; participant authors of the International Society of Nephrology’s 1st International Consensus Meeting on Defining Kidney Failure in Clinical Trials

Collaborators

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

Affiliations

¹ Division of Nephrology, Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada. Electronic address: alevin@providencehealth.bc.ca.
² Department of Medicine, Division of Nephrology, Indiana University School of Medicine, Indianapolis, Indiana, USA; Veterans Administration Medical Center, Indianapolis, Indiana, USA.
³ Medical Research Council Population Health Research Unit, Clinical Trial Service Unit and Epidemiological Studies Unit, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
⁴ Department of Clinical Pharmacy and Pharmacology, University Medical Center Groningen, Groningen, The Netherlands.
⁵ Department of Medicine, Friedrich Alexander University, Erlangen, Germany; KfH Kidney Center, Munich, Germany.
⁶ S. Shahinfar Consulting, Inc., Philadelphia, Pennsylvania, USA; Division of Nephrology, Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia, Pennsylvania, USA.
⁷ Providence Medical Research Center, Providence Health Care, Spokane, Washington, USA; Division of Nephrology, Kidney Research Institute, and Institute of Translational Health Sciences, University of Washington, Seattle, Washington, USA.
⁸ International Society of Nephrology, Brussels, Belgium.
⁹ George Institute for Global Health India, University of New South Wales (UNSW), New Delhi, India; Manipal Academy of Higher Education (MAHE), Manipal, Kamataka, India.
¹⁰ Division of Nephrology and Endocrinology, The University of Tokyo Graduate School of Medicine, Tokyo, Japan.
¹¹ The George Institute for Global Health, Sydney, New South Wales, Australia; Renal Department, Concord Repatriation General Hospital, Sydney, New South Wales, Australia.
¹² Stanford Center for Clinical Research, Department of Medicine, Stanford School of Medicine, Stanford, California, USA.
¹³ Division of Cardiology and Nephrology, Center for Drug Evaluation and Research, Food and Drug Administration (FDA), Silver Spring, Maryland, USA.
¹⁴ Patient Governance Council, Indigenous Peoples Engagement and Research Council, Can-Solve CKD, Vancouver, British Columbia, Canada; Provincial Patient and Family Advisory Council, Ontario Renal Network, Toronto, Ontario, Canada.
¹⁵ Patient Services, Kidney Foundation, BC & Yukon Branch, Burnaby, British Columbia, Canada; Can-Solve CKD, Vancouver, British Columbia, Canada.
¹⁶ External Relations and Patient Engagement, Kidney Research Institute, University of Washington, Seattle, Washington, USA; Center for Dialysis Innovation, University of Washington, Seattle, Washington, USA.
¹⁷ Inland Northwest Culinary Academy at Spokane Community College, Spokane, Washington, USA.
¹⁸ Can-Solve CKD, Vancouver, British Columbia, Canada.
¹⁹ Warren-Charnock Associates, London, UK; Kidney Research UK, London, UK.
²⁰ Faculty of Medicine, University of New South Wales (UNSW), Sydney, New South Wales, Australia.

PMID: 32998816
DOI: 10.1016/j.kint.2020.07.013

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.

Publication types

Research Support, Non-U.S. Gov't

MeSH terms

Consensus
Delphi Technique
Humans
Renal Insufficiency*
Research Design*
Treatment Outcome

Abstract

Publication types

MeSH terms

Grants and funding