Basiliximab (Simulect) reduces acute rejection among sensitized kidney allograft recipients.

Aims: Our goal was to evaluate the efficacy and safety of basiliximab (Simulect) as immunosuppressive induction therapy for the prevention of acute allograft rejection among sensitized kidney recipients.

Methods: Fifty-six adult recipients receiving cadaveric kidney transplant with panel reactive antibody class I ranging from 30% to 50% and or class II 30% to 80% were randomized at about a 2:1 ratio to the Simulect group (36 patients) or matching control group (20 patients). All patients received baseline triple immunosuppressive therapy with cyclosporine (Neoral), mycophenolate mofetil, and steroids. Simulect was given in two doses of 20 mg each on day 0 (2 hours before operation) and day 4 after transplantation.

Results: There was no hyperacute rejection in either group and delayed graft function occurred in three control patients. The incidence of acute rejection during the first 3 months was 11.1% in the Simulect group compared with 50% in the placebo group (77.8% reduction, P < .01). No apparent adverse and toxic events were recorded in the Simulect group. The mean daily dose of steroids was significantly higher in the control group 2 to 4 weeks posttransplantation. No clinically meaningful differences in the mean dose of cyclosporine were observed between the two groups; in addition, there were no statistically significant differences in the rate of patient or graft survival.

Conclusions: On the basis of appropriate selection of the donor and recipient, Simulect is effective and safety for the sensitized recipients as immunosuppressive induction therapy.