Multicenter, prospective, observational study to compare the relative bioavailability of once-daily tacrolimus formulations in de novo kidney transplant recipients. De novo kidney transplant recipients who started a tacrolimus-based regimen were included 14 days post-transplant and followed up for 6 months. Data from 218 participants were evaluated: 129 in the LCPT group (Envarsus®) and 89 in the PR-Tac (Advagraf®) group. Patients in the LCPT group exhibited higher relative bioavailability (Cmin /total daily dose [TDD]) vs PR-Tac (61% increase; p<0.001) with similar Cmin and 30% lower TDD levels (p<0.0001). The incidence of treatment failure was 3.9% in the LCPT group and 9.0% in the PR-Tac group (p = 0.117). Study discontinuation rates were 6.2% in the LCPT group and 12.4% in the PR-Tac group (p = 0.113). Adverse events, renal function and other complications were comparable between groups. The median accumulated dose of tacrolimus in the LCPT group from day 14 to month 6 was 889 mg. Compared to PR-Tac, LCPT showed higher relative bioavailability, similar effectiveness at preventing allograft rejection, comparable effect on renal function, safety, adherence, treatment failure and premature discontinuation rates.

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