ArticleEuropean journal of drug metabolism and pharmacokinetics2026
Concentration-to-Dose Ratio Differences Between Once-Daily Tacrolimus Formulations: A Five-Year Real-World Pharmacokinetic Study in Kidney Transplantation.
Article in European journal of drug metabolism and pharmacokinetics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
BACKGROUND AND
objectiveTacrolimus is a cornerstone of immunosuppression after kidney transplantation; however, its narrow therapeutic window and substantial inter- and intra-individual pharmacokinetic variability complicate dose optimization. Extended-release tacrolimus (ER-Tac) and MeltDose
methodsIn this single-center retrospective study, 100 de novo kidney transplant recipients (2015-2018) received either ER-Tac (n = 50) or LCP-Tac (n = 50). Tacrolimus trough concentrations, daily doses, and laboratory parameters were collected up to 60 months post-transplantation. Longitudinal pharmacokinetic assessment was performed using repeated C/D ratio measurements. Linear mixed-effects models adjusted for recipient age and time post-transplantation were used for analysis. Clinical outcomes included delayed graft function (DGF), biopsy-proven acute rejection (BPAR), new-onset diabetes after transplantation (NODAT), and mortality.
resultsLCP-Tac-treated patients required significantly lower daily doses from month 3 onward (p < 0.001) while maintaining comparable trough concentrations. The C/D ratio was consistently higher in the LCP-Tac group, reaching statistical significance from month 12 (p = 0.015) and increasing further over time (p < 0.001), suggesting lower apparent tacrolimus clearance and/or greater dose-normalized exposure. A higher proportion of LCP-Tac measurements remained within the predefined therapeutic range throughout follow-up. No significant differences were observed in DGF, BPAR, NODAT, or mortality between groups.
conclusionLCP-Tac was associated with lower dose requirements and higher, more stable C/D ratios compared with ER-Tac, suggesting formulation-dependent differences in tacrolimus pharmacokinetics. The C/D ratio may serve as a simple, clinically applicable surrogate marker for long-term pharmacokinetic monitoring in kidney transplant recipients.
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Registered trials
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