Combination of Extended-Release Tacrolimus Plus Everolimus Once Daily in Dc Novo Kidney Transplant Recipients: ER-Tac vs LCPT

Introduction. 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 vMedian 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. 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. 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.