title: A double-blind, placebo-controlled study of monoclonal anti-interleukin-2 receptor antibody (BT563) administration to prevent acute rejection after kidney transplantation.
abstract: In a double-blind, randomized, placebo-controlled trial, BT563, a murine IgG1 anti-IL-2R antibody, was given as a rejection prophylaxis after kidney transplantation. Drug-related side effects were not observed. During the 10-day course of BT563, no rejections (0/27) were found, whereas a rejection episode occurred in 7 patients (7/29) (P = 0.01) during placebo treatment. Within the first 4 postoperative weeks, freedom from rejection in the BT563 group and in the placebo group was 96% vs. 76% (P = 0.05). Due to rejection in the placebo group, 2 grafts were lost. At 3 months, an overall rejection incidence in the BT563 and placebo group was found of 3/27 (11%) vs. 8/29 (28%) patients (P = 0.18). Infectious complications were distributed equally between the 2 groups. CMV disease, found in 3 placebo-treated patients, occurred after rejection treatment (2/3). Within the BT563 group, 1 patient lost his graft due to renal artery thrombosis, 2 grafts were lost as a result of technical failure, and 2 patients had a squamous cell carcinoma that could be treated curatively. We conclude that the use of the anti-IL-2R mAb BT563 effectively prevents rejection after kidney transplantation without increasing infectious complications.
authors.affiliation: Department of Internal Medicine I, University Hospital Rotterdam, The Netherlands.
authors.forename: T
authors.initials: T
authors.lastname: van Gelder
authors.forename: R
authors.initials: R
authors.lastname: Zietse
authors.forename: A H
authors.initials: AH
authors.lastname: Mulder
authors.forename: J N
authors.initials: JN
authors.lastname: Yzermans
authors.forename: C J
authors.initials: CJ
authors.lastname: Hesse
authors.forename: L M
authors.initials: LM
authors.lastname: Vaessen
authors.forename: W
authors.initials: W
authors.lastname: Weimar
mesh_terms: D000208:Acute Disease; D000328:Adult; D000368:Aged; D000818:Animals; D000911:Antibodies, Monoclonal / Q000009:adverse effects / Q000097:blood / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006084:Graft Rejection / Q000097:blood / Q000276:immunology / Q000517:prevention & control*; D006801:Humans; D007239:Infections / Q000139:chemically induced / Q000209:etiology; D016030:Kidney Transplantation / Q000009:adverse effects / Q000276:immunology*; D007683:Kidney Tubular Necrosis, Acute / Q000139:chemically induced / Q000209:etiology; D007959:Lymphocyte Culture Test, Mixed; D008297:Male; D051379:Mice; D008875:Middle Aged; D010919:Placebos; D015375:Receptors, Interleukin-2 / Q000276:immunology*
chemical_list: D000911:Antibodies, Monoclonal; D010919:Placebos; D015375:Receptors, Interleukin-2