Randomized trial of thymoglobulin versus alemtuzumab (with lower dose maintenance immunosuppression) versus daclizumab in living donor renal transplantation.
Author(s): Ciancio G, Gaynor JJ, Roth D, Kupin W, Hanson L, Tueros L, Zarak A, Ruiz P, Burke GW 3rd
Affiliation(s): Department of Surgery, The Lillian Jean Kaplan Renal Transplant Center of the Division of Transplantation, University of Miami Leonard M. Miller School of Medicine, Miami, Florida, USA.
Publication date & source: 2010-11, Transplant Proc., 42(9):3503-6.
Publication type: Comparative Study; Randomized Controlled Trial
BACKGROUND: We performed a randomized trial evaluating alemtuzumab, a humanized anti-CD52 monoclonal antibody, in living donor (LD) kidney transplantation. METHODS: Thirty-eight LD first renal transplant recipients were randomized into three single-agent antibody induction groups: thymoglobulin (group A); alemtuzumab (group B); and daclizumab (group C). In groups A and C, target tacrolimus trough levels were 6 to 8 ng/mL, with 1 gm mycophenolate mofetil (MMF) administered twice daily, and maintenance methylprednisolone. In group B, the target tacrolimus trough level was 4 to 6 ng/mL, with 500 mg MMF administered twice daily, without methylprednisolone. RESULTS: With 29/38 patients now followed beyond 36 months posttransplantation, we observed no graft failures and only one death with a functioning graft (in group B). Acute rejection episodes were low: 0/13, 1/13, and 1/12 patients in groups A, B, and C. Biopsy-proven chronic allograft injury was higher among group B (3/13) versus groups A (0/13) or C (0/12; P = .01). Poorer renal function was observed in group B; the mean calculated creatinine clearance at 3 months posttransplantation was significantly poorer: 63.3 +/- 3.0 versus 85.4 +/- 7.2 and 82.2 +/- 8.2 in groups A and C (P = .01). No differences in the incidence of adverse events were observed. Copyright (c) 2010 Elsevier Inc. All rights reserved.