The purpose of this study is to gather information regarding the use of Myfortic, Prograf, and corticosteroids in new liver transplant recipients. These three medicines help to prevent the body from rejecting the transplanted liver. The information the investigators are obtaining is data relating to the process of Myfortic absorption by the body, its distribution in the body, the breakdown of Myfortic in the body, and its elimination from the body. This absorption, distribution, breakdown, and elimination is called pharmacokinetics.
Myfortic is approved for use in kidney transplant recipients, and has been prescribed by doctors for liver transplant recipients. No study has been reported to date evaluating the pharmacokinetics of Myfortic in new liver transplant recipients who also take Prograf and corticosteroids. During this six month study, a series of blood samples will be obtained after subjects take Myfortic, Prograf, and corticosteroids.
Study Type
OBSERVATIONAL
Enrollment
25
1440mg/day for 6 months posttransplant
The Methodist Hospital System
Houston, Texas, United States
Pharmacokinetic parameters
Pharmacokinetic time points will be obtained at 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 8, and 12 hours post dose. The exposure (area under the concentration-time curve, AUC μg·h/mL, Cmax ng/mL, and Tmax, hours) of MPA and MPAG will be calculated using non-compartmental analysis.
Time frame: Twelve hour pharmacokinetics at one week, one month, and six months post transplant
Safety and tolerability
MPA exposure will be assessed at one week, 1 month, and 6 months. Kidney function (using MDRD and Cockcroft-Gault) will be compared with PK parameters and graft survival recorded. Adverse events will be recorded.
Time frame: 1 week, 1 month, 6 months
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