*Purpose: Combination of Everolimus (EVR) with Tacrolimus (Tac) permits reduced calcineurin inhibitors exposure and, recently, has been demonstrated safe and effective. Two different once-daily Tacrolimus formulations, with different pharmacokinetic profiles are now available: ER-Tac and LCPT. Aim of this study was to compare in kidney transplant recipients (KTx), the short-term efficacy and safety of ER-Tac versus LCPT, both in combination with EVR, administered concomitantly once a day.

*Methods: Fifty-seven KTx were open randomized to once-daily maintenance immunosuppressive regimen based on ER-Tac + EVR + Steroids (ER-Tac+EVR, n=30) or LCPT + EVR + Steroids (LCPT+EVR, n=27). All patients received induction therapy with Thymoglobuline (total dose 200 mg).

*Results: Median follow-up was 10 months (range 3-18). Here we present the intention-to-treat analysis at 6 months. There were no differences in patients as well as in graft survival. Moreover, we found no differences in renal function, acute rejection rate, CMV infection. (Table 1). According to the Concentration/Dose ratio of Tacrolimus, there was a significantly higher number of slow metabolizers 1-month after transplant in the LCPT+EVR group. (Table 2).

*Conclusions: Our data show that the two extended release Tac formulations, when administered with EVR once-daily, have comparable 6-month safety and efficacy. We can speculate that the higher number of slow metabolizers in the LCPT group may be an advantage to reach target exposure early after transplantation.

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