Renal Transplantation Clinical Trial
Official title:
Prospective Pharmacokinetic and Pharmacogenetic Analysis of Advagraf After Transplantation
A pharmacokinetics and pharmacogenetics study to complement the current knowledge of
tacrolimus prolonged release (Advagraf®) in the immediate post-transplantation period and at
steady-state (M3 post transplantation) and to improve the optimal dose of Advagraf® based on
tacrolimus AUC estimated by two Limited Samples Strategies during the first 3 months after
renal transplantation.
Data obtained with tacrolimus prolonged release will be compared with those of tacrolimus
immediate release (Prograf®)
Multicentre open-labeled randomized pharmacokinetic (PK) and pharmacogenetic (PG) study to
compare Advagraf and Prograf immediate post-transplantation (Day 8) and steady-state (Day
84) systemic exposure.
Tacrolimus PK profile, tacrolimus systemic exposure assessed by Limited Samples Strategies
(LSS) (i.e.: Bayesian estimators (BE) and Multilinear Regressions (MLR)), and impact of
CYP3A5 and ABCB1 genetic polymorphisms on tacrolimus PK will also be determined to improve
the optimal dose of Advagraf® for kidney transplant patients.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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