Proposed consensus for definitions and endpoints for clinical trials of acute kidney transplant rejection

American Journal of Kidney Diseases : the Official Journal of the National Kidney Foundation
R D GuttmannT J Schroeder

Abstract

Progress in transplantation therapeutics requires validation from multicenter trials in which enrollment criteria and endpoint definitions have been standardized. A database of acute rejection was established from 19 North American, European, and Australian transplant centers and included parameters on rejection diagnosis and treatment of 50 consecutive rejection episodes from each center. Patient demographics, induction and maintenance immunosuppressive therapies, antirejection agents (drug, dose, duration), clinical signs (decrease in urine volume, presence of fever of > or =38.5 degrees C), serum creatinine concentration (nadir, at rejection, daily during antirejection therapy to 15 days, and days 30, 90, 180, and 365 after rejection date), rejection biopsy findings, morbidity, recurrence of rejection, and renal function at 1 year were recorded for 953 rejection episodes. From these data, three definitions were proposed. Acute rejection was defined as an immunologic process resulting in a serum creatinine increase of > or =0.4 mg/dL, with or without clinical signs, and should include a biopsy confirmation that has been standardized to the Banff criteria. Corticosteroid-resistant rejection was defined as a rejection episode i...Continue Reading

Citations

Nov 12, 2013·The Surgical Clinics of North America·Lillian W GaberSamir J Patel
Oct 4, 2003·American Journal of Transplantation : Official Journal of the American Society of Transplantation and the American Society of Transplant Surgeons·Kevin C Abbott
Apr 14, 2006·BMC Bioinformatics·Tricia A Thornton-WellsJonathan L Haines
Apr 25, 2007·Transplantation·Mario Abbud-FilhoFrancis L Delmonico
Jan 22, 2004·American Journal of Physiology. Renal Physiology·Ying ZhangChristopher Y Lu
Feb 27, 2018·Canadian Journal of Kidney Health and Disease·Julie LeblancHéloïse Cardinal
Sep 18, 2010·Journal of Nuclear Medicine : Official Publication, Society of Nuclear Medicine·Stefan ReuterMichael Schäfers
Dec 4, 2021·American Journal of Transplantation : Official Journal of the American Society of Transplantation and the American Society of Transplant Surgeons·Julie HoAhmed M Abou-Setta

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