taken to assess the influence of ATG induction on tacrolimus (Tac)-based and cyclosporine microemulsion (CyA)based triple therapies compared with immediate tacrolimus triple therapy. In the absence of induction, Tac-based therapies have consistently proved superior to CyA-based therapies in reducing the rates of acute rejection after renal transplantation. 2 METHODS The 6-month, open-label, randomised, prospective, parallel-group study was conducted in 30 European centres. Patients were randomly assigned to immediate Tac therapy (Tac triple) (n185) or ATG/Tac (n186) or ATG/CyA (n184). Administration of azathioprine (AZA) and corticosteroids was initiated on the day of transplantation (day 0) in all groups. In the Tac triple group, tac administration commenced at day 0, but in the patients receiving ATG induction, Tac and CyA administration was delayed for 9 days. The initial ATG dose (day 0) was 1.25 mg/kg and subsequent doses were adjusted according to the patients’ conditions. ATG dosing was discontinued on day 11. The initial doses for Tac and CyA were 0.30 mg/kg per day and 8 mg/kg per day, respectively, each given in two divided doses. The target whole blood trough levels up to day 42 and from day 43 to 180 were: Tac 10 to 20 ng/mL and 5 to 15 ng/mL, respectively, and CyA 150 to 300 ng/mL and 100 to 200 ng/mL, respectively. Corticosteroids were administered intravenously to all three groups at 500 mg on day 0 and 125 mg on day 1. The subsequent doses were tapered from 20 mg (day 2) to 10 mg (days 91 to 180). AZA was administered at 2 mg/kg IV on day 0, and 1 to 2 mg/kg PO up to day 90, thereafter dosing could be discontinued. The study was undertaken in accordance with the Declaration of Helsinki and approved by the local ethics committees. Written informed consent was obtained from all participants. RESULTS The baseline characteristics of three treatment groups were well balanced. Of the intent-to-treat population, a total of 22 Tac triple patients, 28 ATG/Tac patients, and 38 ATG/ CyA patients withdrew during the study, mostly because of adverse events. A total of 13 patients (5, 3, and 5, respectively) died either during the study or after withdrawal. Of the intent-to-treat population, 86.5% of the Tac triple patients, 83.3% of the ATG/Tac patients, and 77.7% of the ATG/CyA patients completed the 6-month study. The mean trough blood concentrations for Tac and CyA remained within the recommended ranges throughout. Based on the intent-to-treat population, differences in estimated patient and graft survival rates over 6 months were not significant between the three groups (KaplanMeier method). For the Tac triple, ATG/Tac, and ATG/ CyA groups, patient survival was 97.0%, 98.4%, and 97.0%,