A Randomized 2x2 Factorial Trial, Part 1: Single-Dose Rabbit Antithymocyte Globulin Induction May Improve Renal Transplantation Outcomes

• Published in: Transplantation Vol. 99; no. 1; pp. 197 - 209
• Main Authors: Stevens, R Brian, Foster, Kirk W, Miles, Clifford D, Lane, James T, Kalil, Andre C, Florescu, Diana F, Sandoz, John P, Rigley, Theodore H, Nielsen, Kathleen J, Skorupa, Jill Y, Kellogg, Anna M, Malik, Tamer, Wrenshall, Lucile E
• Format: Journal Article
• Language: English
• Published: 15-01-2015
• ISSN: 0041-1337
• DOI: 10.1097/TP.0000000000000250

We conducted a randomized and unblinded 2 x 2 sequential-factorial trial, composed of an induction arm comparing single-dose (SD) versus divided-dose rabbit anti-thymocyte globulin (rATG), and a maintenance arm comparing tacrolimus minimization versus withdrawal. We report the long-term safety and efficacy of SdrATG induction in the context of early steroid withdrawal and tacrolimus minimization or withdrawal. Patients received 6 mg/kg rATG, SD or four alternate-day doses, with early steroid withdrawal and tacrolimus or sirolimus maintenance. Primary endpoints were renal function and chronic graft histopathology. Secondary endpoints included patient survival, graft survival, biopsy-proven rejection, and infectious or noninfectious complications. The SdrATG induction improves the 3year renal function in recipients of deceased donor kidneys. This benefit, along with possibly improved patient survival and fewer infections suggest that how rATG is administered may impact its efficacy and safety.