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A previous nonblinded, randomized, single‐center renal transplantation trial of single‐dose rabbit anti‐thymocyte globulin induction ( SD ‐ rATG ) showed improved efficacy compared with conventional divided‐dose ( DD ‐ rATG ) administration. The present multicenter, double‐blind/double‐dummy  STAT  trial (Single dose vs. Traditional Administration of Thymoglobulin) evaluated  SD ‐ rATG  versus  DD ‐ rATG  induction for noninferiority in early (7‐day) safety and tolerability. Ninety‐five patients (randomized 1:1) received 6 mg/kg  SD ‐ rATG  or 1.5 mg/kg/dose  DD ‐ rATG , with tacrolimus‐mycophenolate maintenance immunosuppression. The primary end point was a composite of fever, hypoxia, hypotension, cardiac complications, and delayed graft function. Secondary end points included 12‐month patient survival, graft survival, and rejection. Target enrollment was 165 patients with an interim analysis scheduled after 80 patients. Interim analysis showed primary end point noninferiority of  SD ‐ rATG  induction (p = 0.6), and a conditional probability of <1.73% of continued enrollment producing a significant difference (futility analysis), leading to early trial termination. Final analysis (95 patients) showed no differences in occurrence of primary end point events (p = 0.58) or patients with no, one, or more than one event (p = 0.81), or rejection, graft, or patient survival (p = 0.78, 0.47, and 0.35, respectively). In this rigorously blinded trial in adult renal transplantation, we have shown  SD ‐ rATG  induction to be noninferior to  DD ‐ rATG  induction in early tolerability and equivalent in 12‐month safety. (Clinical Trials.gov #NCT00906204.)

american journal of transplantation

A Double‐Blind, Double‐Dummy, Flexible‐Design Randomized Multicenter Trial: Early Safety of Single‐ Versus Divided‐Dose Rabbit Anti‐Thymocyte Globulin Induction in Renal Transplantation