Myfortic, Prograf, and Corticosteroids in de Novo Liver Transplantation
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||An Open-label Study of the Pharmacokinetics of Mycophenolic Acid as Myfortic (Enteric-coated Mycophenolate Sodium) When Used in Combination With Prograf (Tacrolimus) and Corticosteroids in Patients Undergoing de Novo Liver Transplantation|
- Pharmacokinetic parameters [ Time Frame: Twelve hour pharmacokinetics at one week, one month, and six months post transplant ] [ Designated as safety issue: No ]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.
- Safety and tolerability [ Time Frame: 1 week, 1 month, 6 months ] [ Designated as safety issue: No ]MPA exposure will be assessed at one week, 1 month, and 6 months. Kidney function (using MDRD and Cockroft-Gault) will be compared with PK parameters and graft survival recorded. Adverse events will be recorded.
Biospecimen Retention: Samples Without DNA
Serum will be retained and frozen for MPA levels
|Study Start Date:||December 2010|
|Estimated Study Completion Date:||December 2012|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
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.
|United States, Texas|
|The Methodist Hospital System|
|Houston, Texas, United States, 77030|
|Principal Investigator:||R M Ghobrial, MD, PhD||The Methodist Hospital System|