The 36-month visit was completed by 124 patients, of whom 61 remained on study treatment (Figure 1). One additional patient who had been randomized to the steroid withdrawal group was included inadvertently despite not receiving EC-MPS and CsA at completion of the DOMINOS study and was included only in the safety analyses. Figure 1 Patient disposition. The demographics and baseline characteristics free copy of the patient population were balanced between treatment groups (Table 1). There was a lower proportion of patients with delayed graft function in the steroid avoidance group than the steroid withdrawal group but the difference was not statistically significant (11.4% versus 21.3% group; P = 0.12). The INFINITY study population showed no marked differences to the full cohort of patients who took part in the DOMINOS study [9].

Table 1 Demographics and baseline characteristics. 3.2. Immunosuppression At month 6 after transplant, 19/70 patients (27.1%) randomized to steroid avoidance were receiving oral steroids. Steroid therapy was introduced in an additional three patients by month 36. In the steroid withdrawal group, 34/61 patients received steroids at month 6 (55.7%) as per protocol (steroids were to be continued if subclinical rejection was observed on the month 3 protocol biopsy); four additional patients discontinued steroids by month 36. Overall, the mean cumulative dose of steroids per patient to month 36 was approximately a third lower in the steroid avoidance group (2467.8mg versus 3397.7mg in the steroid withdrawal group; P = 0.058) (Table 2).

Table 2 Immunosuppression at months 6 and 36. Of the 126 patients who completed the 36-month visit alive and with a functioning graft, 114 (90.5%) continued to receive MPA therapy. Seventeen patients (13.7%) had switched from CsA to tacrolimus and two patients randomized to the steroid withdrawal group had switched from CNI therapy to a mammalian target of rapamycin (mTOR) inhibitor (Table 2). Data on immunosuppression among the 124 patients who completed the 36-month visit alive and with a functioning graft are shown in Table 2. 3.3. Efficacy The primary efficacy endpoint occurred in 10/70 (14.3%, 95% CI 6.1�C22.5%) patients in the steroid avoidance group and 6/61 (9.8%, 95% CI 2.4�C17.3%) of the steroid withdrawal group by month 12 after transplant (P = 0.44). At month 36 after transplant, the corresponding values were 15/70 (21.

4%, 95% CI 11.8�C31.0%) and 10/61 (16.4%, 95% CI 7.1�C25.7%) (P = 0.46). The incidence of BPAR was 20.0% (14/70) in the steroid avoidance group Anacetrapib versus 11.5% (7/61) with steroid withdrawal (P = 0.19), with the most severe grade of BPAR being classified as grade IA in 9/14 steroid avoidance patients (Table 3). Kaplan-Meier estimates indicated that the probability of remaining free from treatment failure at month 36 was 79.9% and 88.4% in the steroid avoidance and steroid withdrawal groups, respectively (P = 0.