title: A randomized, double-blind, placebo-controlled, multicenter study of rabbit ATG in the prophylaxis of acute rejection in lung transplantation.
abstract: 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.
authors.affiliation: Lung Transplant Service, Department of Allergy, Immunology and Respiratory Medicine, The Alfred Hospital, Melbourne, Australia.
authors.forename: G I
authors.initials: GI
authors.lastname: Snell
authors.forename: G P
authors.initials: GP
authors.lastname: Westall
authors.forename: B J
authors.initials: BJ
authors.lastname: Levvey
authors.forename: P
authors.initials: P
authors.lastname: Jaksch
authors.forename: S
authors.initials: S
authors.lastname: Keshavjee
authors.forename: C W
authors.initials: CW
authors.lastname: Hoopes
authors.forename: V
authors.initials: V
authors.lastname: Ahya
authors.forename: A
authors.initials: A
authors.lastname: Mehta
authors.forename: E P
authors.initials: EP
authors.lastname: Trulock
mesh_terms: D000328:Adult; D000818:Animals; D000961:Antilymphocyte Serum / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006084:Graft Rejection / Q000175:diagnosis / Q000517:prevention & control*; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D016040:Lung Transplantation; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D011446:Prospective Studies; D011817:Rabbits
chemical_list: D000961:Antilymphocyte Serum; D007166:Immunosuppressive Agents
keywords: Acute rejection; alloreactivity; induction immunosuppression; lung transplantation; rabbit ATG