International consensus definitions of clinical trial outcomes for kidney failure: 2020
Levin A., Agarwal R., Herrington WG., Heerspink HL., Mann JFE., Shahinfar S., Tuttle KR., Donner JA., Jha V., Nangaku M., de Zeeuw D., Jardine MJ., Mahaffey KW., Thompson AM., Beaucage M., Chong K., Roberts GV., Sunwold D., Vorster H., Warren M., Damster S., Malik C., Perkovic V., Anand S., Argent N., Babak E., Banerjee D., Barratt J., Bello AK., Bernardo AA., Blais J., Canovatchel W., Caskey FJ., Coresh J., de Boer IH., Eckardt KU., Evans RD., Feldman HI., Fogo AB., Gudmundsdottir H., Hamano T., Harris DCH., Hauske SJ., Haynes R., Herzog CA., Hiemstra T., Idorn T., Inker L., Ishida JH., Johnson DW., Jones-Burton C., Joseph A., Koitka-Weber A., Kretzler M., Lawatscheck R., Liew A., Moist L., Naicker S., Nakashima R., Patel U., Filho RP., Rose JB., Rosenberg NL., Sinsakul M., Smoyer WE., Sola L., Sood AR., Stengel B., Taal MW., Tanaka M., Tonelli M., Tong A., Toto R., Trask M., Ulasi II., Wanner C., Wheeler DC., Wolthers BO., Wright HM., Yamada Y., Zakharova E.
© 2020 International Society of Nephrology 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.