A Randomized, Double‐Blind, Placebo‐Controlled, Multicenter Study of Rabbit ATG in the Prophylaxis of Acute Rejection in Lung Transplantation

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. This randomized placebo‐controlled trial of induction therapy in lung transplantation demonstrates that a single early posttransplant dose of ATG‐Fresenius does not reduce acute cellular rejection, graft loss, or death within the first year of lung transplantation.