Drug Interaction Potentiation Clinical Trial
Official title:
The Effect of Everolimus on the Pharmacokinetics of Tacrolimus in Renal Transplant Patients, and the Effect of ABCB1、CYP3A4、CYP3A5、PORGenetic Polymorphism on the Two Drugs
The purpose of this study is to understand the effects of everolimus on tacrolimus pharmacokinetics (pk) in patients receiving de novo kidney transplants.
Multidrug immunosuppression regimens have synergistic effects which allow the use of lower
doses of individual agents. These regimens generally include calcineurin inhibitors (CNIs:
cyclosporine or tacrolimus), mammalian target of rapamycin (mTOR) inhibitors (everolimus or
sirolimus), and corticosteroids. CNIs and mTOR inhibitors are substrates for cytochrome P450
3A4 (CYP3A4) and P-glycoprotein (P-gp); in addition, cyclosporine is a inhibitor of CYP3A4
and P-gp. Therefore, concomitant administration of those drugs may alter their serum levels.
It is remained to be evaluated whether the pharmacokinetics or clinical efficacy of
tacrolimus will be affected when the regimens contain everolimus in clinical practice and the
effect of ABCB1、CYP3A4、CYP3A5、POR genetic polymorphism on the two Drugs. Mycophenolate
mofetil (MMF) has no effect on pharmacokinetics of tacrolimus; therefore, MMF is used as a
control to understand the effects of everolimus on pharmacokinetics of tacrolimus in patients
receiving de novo kidney transplants. The effect of ABCB1、CYP3A4、CYP3A5、POR genetic
polymorphism on the two Drugs was also assessed.
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