A double-blind, placebo-controlled study of monoclonal anti-interleukin-2 receptor antibody (BT563) administration to prevent acute rejection after kidney transplantation

• Published in: Transplantation Vol. 60; no. 3; p. 248
• Main Authors: van Gelder, T, Zietse, R, Mulder, A H, Yzermans, J N, Hesse, C J, Vaessen, L M, Weimar, W
• Format: Journal Article
• Language: English
• Published: United States 15.08.1995
• Subjects: Acute Disease; Adult; Aged; Animals; Antibodies, Monoclonal - adverse effects; Antibodies, Monoclonal - blood; Antibodies, Monoclonal - therapeutic use; Double-Blind Method; Female; Graft Rejection - blood; Graft Rejection - immunology; Graft Rejection - prevention & control; Humans; Infection - chemically induced; Infection - etiology; Kidney Transplantation - adverse effects; Kidney Transplantation - immunology; Kidney Tubular Necrosis, Acute - chemically induced; Kidney Tubular Necrosis, Acute - etiology; Lymphocyte Culture Test, Mixed; Male; Mice; Middle Aged; Placebos; Receptors, Interleukin-2 - immunology
• ISSN: 0041-1337
• DOI: 10.1097/00007890-199508000-00007

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.