Alemtuzumab (Campath 1H) induction with tacrolimus monotherapy is safe for high immunological risk renal transplantation

Immunosuppression for immunologically high-risk renal transplant patients usually involves antithymocyte globulin induction with triple drug maintenance therapy. Alemtuzumab, a humanized anti-CD52 antibody, has shown promise in tolerogenic induction protocols, requiring minimal maintenance immunosuppression. In this prospective, openlabel, randomized, controlled trial, we enrolled 21 high immunological risk patients (i.e., panel reactive antibody >20% or previous transplant). Patients received either single-dose alemtuzumab given before graft reperfusion, with tacrolimus monotherapy, or four doses of Thymoglobulin (R) with tacrolimus, mycophenolate, and steroids. Median follow-up was 377 days. One patient in the Thymoglobulin group who suffered primary graft nonfunction died. One-year cumulative graft survival was 85.7% for the alemtuzumab group and 87.5% for the Thymoglobulin group. Two alemtuzumab and three Thymoglobulin patients suffered rejection episodes. Infection rates were similar. Early results of this ongoing study indicate that a tolerogenic protocol with alemtuzumab induction and tacrolimus maintenance monotherapy is safe in immunologically high-risk renal transplant patients.