A randomized, double-blind trial of basiliximab immunoprophylaxis plus triple therapy in kidney transplant recipients

Background. A double-blind, placebo-controlled, randomized study was perfor med to assess whether immunoprophylaxis with basiliximab (Simulect(R)) coul d reduce the incidence of acute rejection in kidney transplant recipients t reated with cyclosporine (Neoral(R)), steroids, and azathioprine. Methods. Three hundred forty patients received either placebo or basilixima b at a dose of 20 mg, given intravenously on days 0 and 4. All patients rec eived cyclosporine, steroids, and azathioprine. The primary endpoint was th e incidence of acute rejection at 6 months. Secondary endpoints included th e safety and tolerability of basiliximab and placebo, 1-year patient and gr aft survival, and significant medical events up to 12 months. Results. During the first 6 months posttransplantation, acute rejection occ urred in 20.8% of patients given basiliximab versus 34.9% of patients admin istered placebo (P=0.005). Similarly, there was a reduction in biopsy-prove n acute rejection at 6 months in the patients receiving basilixiniab (P=0.0 23). One-year patient survival was 97.6% with basiliximab and 97.1% with pl acebo, graft survival was 91.5% versus 88.4%, respectively (NS). The advers e-events profile of patients treated with basiliximab was indistinguishable from that of patients treated with placebo. The number of patients with in fections was similar (65.5% for basiliximab vs. 65.7% for placebo), includi ng cytomegalovirus infections (17.3% vs. 14.5%, P=0.245). Nine neoplasms (t hree in the basiliximab group, six in the placebo arm) were recorded up to 1 year from transplantation. Conclusions. Basiliximab in combination with cyclosporine, steroids, and az athioprine triple therapy was highly effective in reducing the incidence of acute renal allograft rejection without increasing the incidence of infect ions and other side effects.