A randomized, double-blind, placebo-controlled, multicenter study of rabbit ATG
in the prophylaxis of acute rejection in lung transplantation.
Author(s): Snell GI(1), Westall GP, Levvey BJ, Jaksch P, Keshavjee S, Hoopes CW, Ahya V,
Mehta A, Trulock EP 3rd; ATG Study Investigators.
Affiliation(s): Author information:
(1)Lung Transplant Service, Department of Allergy, Immunology and Respiratory
Medicine, The Alfred Hospital, Melbourne, Australia.
Publication date & source: 2014, Am J Transplant. , 14(5):1191-8
ATG-Fresenius S (ATG-F) is a polyclonal anti-human-T-lymphocyte immunoglobulin
preparation that has been clinically developed to prevent episodes of acute
cellular rejection. This study evaluated the efficacy and safety of ATG-F at
doses of 5 and 9 mg/kg versus placebo in adult recipients of a primary lung
allograft. The primary efficacy composite end point was defined as death, graft
loss, acute rejection and/or loss to follow-up within 12 months of
transplantation. The interim analysis showed the ATG-F 5 mg/kg treatment to be
inefficacious, and it would be impossible to enroll enough patients to power the
study to show a difference between the 9 mg/kg arm and the placebo arm.
Therefore, the main focus of the study shifted to the safety end points and a
descriptive analysis of the primary end point. At 12 months posttransplant, the
efficacy failure rate was not significantly different between the ATG-F 9 mg/kg
group and the placebo group (40.2% vs. 36.7%, respectively). This large study did
not demonstrate a significant reduction in acute cellular rejection, graft loss
or death with single-dose induction therapy with ATG-F within the first year
after lung transplantation.
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