4.1 Article

Randomized Trial of Thymoglobulin Versus Alemtuzumab (with Lower Dose Maintenance Immunosuppression) Versus Daclizumab in Living Donor Renal Transplantation

Journal

TRANSPLANTATION PROCEEDINGS
Volume 42, Issue 9, Pages 3503-3506

Publisher

ELSEVIER SCIENCE INC
DOI: 10.1016/j.transproceed.2010.08.045

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Funding

  1. Roche Laboratories, Inc.

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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.

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