The purpose of this study was to compare the safety and efficacy of two dosing regimen of daclizumab with no-antibody induction in simultaneous kidney-pancreas transplant (SKPT) recipients receiving tacrolimus, mycophenolate mofetil, and steroids. Methods. A total of 297 SKPT patients were enrolled into this prospective, multicenter, randomized, open-label study. The patients were randomized into three groups: daclizumab 1 mg/kg/dose every 14 days for five doses (group I, n = 107), daclizumab 2 mg/kg/dose every 14 days for two doses (group II, n = 112), and no-antibody induction (group III, n = 78). Results. There were no differences in baseline characteristics among the three groups, except for a higher proportion of African-Americans in group II. The incidence of composite events (acute rejection, graft loss, or death) at 1 year was 36.4%, 32.7%, and 48.7% for groups I, II, and III, respectively (P < .05, group II vs group III). The incidence of acute rejection was highest in group III (34.6%) compared to groups I and II (22.4% and 22.1%, respectively, P < .05). The mean time to acute rejection was delayed in group II (96 days) compared to 23 days in group I and 20 days in group III (P < .05). The adverse-event profiles were comparable among the three groups, except for a higher incidence of infection and readmissions in group III. Conclusions. Daclizumab was safe and effective in reducing the incidence of acute rejection when compared to no induction. The alternative two-dose regimen of daclizurnab was as effective as the conventional five-dose regimen and is logistically more desirable.
