A smaller study (N = 39) by the same group reported no differences in patient survival, graft survival, or BPAR incidence between patients receiving SRL/standard TAC and those receiving SRL/reduced TAC (Table 1) [49]. However, 38% and 6% of patients on standard TAC were discontinued due to TAC nephrotoxicity and thrombotic microangiopathy, respectively. Several factors may have contributed to the apparent increased nephrotoxicity, including the study population (79% black), use of kidneys from deceased

donors, and high incidence of delayed graft function (59%). Two-year data compared similar regimens in 132 live donor renal allotransplant patients [50]. The efficacy outcomes were patient survival and graft

survival, BPAR incidence, and graft function. At 2 years, renal function BAY 80-6946 was significantly improved with the TAC-free regimen (SRL/MMF), compared with EX527 the SRL/TAC-sparing regimen, as measured by serum creatinine level and calculated GFR (both p < 0.05; Table 1). In addition, the rate of acute rejection was numerically lower in the TAC-free group (13.5% vs 18.5%; p = ns). Three-year results from a long-term study (N = 150) comparing SRL/TAC, MMF/TAC, and SRL/CsA are also available [51]. At 3 years, patient survival, graft survival, and BPAR incidence did not differ significantly among the 3 groups (Table 1), although the latter showed a trend in favor of MMF/TAC (p = 0.07). Although renal function (as measured by creatinine) was acceptable in each of the 3 groups, the MMF/TAC group was statistically more favorable when compared with SRL/CsA at 12, 24, and 36 months

(p = 0.02, p = 0.05, Fenbendazole and p = 0.04, respectively) and SRL/TAC at 24 months (p = 0.05). Rates of NODM by year 3 were lowest with MMF/TAC (11% vs 27–31% in other groups). Longer-term follow-up of the same study (median of 8 years) showed significant differences or trends with respect to the above endpoints that consistently favored MMF/TAC over the other regimens [52]. Viral infections and need for antilipid therapy were significantly lower with MMF/TAC versus the other regimens combined (p < 0.05), and the incidence of NODM was numerically lower with MMF/TAC (Table 1). Similar long-term findings were reported by Chhabra and colleagues [53]. In their study, 82 renal transplant recipients were followed for up to a mean of 8.5 years. MMF/TAC provided better efficacy and safety than SRL/TAC, with significant differences seen for graft survival and GFR (Table 1). In summary, results to date are derived mainly from single-center studies, and thus more robust data are needed to confirm the preliminary findings. Two small-scale studies compared reduced-dose TAC versus standard-dose TAC, when used in combination with SRL [47] and [49].