Myfortic, Prograf, and Corticosteroids in de Novo Liver Transplantation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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End Stage Liver Disease

Intervention / Treatment
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* Drug: Enteric-coated Mycophenolate Sodium


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults > or equal to age 18 years Planned to receive tacrolimus and corticosteroid therapy posttransplant Serum creatinine at transplant < or equal to 2.5mg/dL UCSF tumor staging < 8cm total Females of childbearing potential must have a negative serum pregnancy test within 7 days prior to the baseline visit and are required to practice a reliable method of contraception for the duration of the study and for no fewer than 6 weeks after completing the study. Signed informed consent form prior to any research assessment Exclusion Criteria: Induction therapy Requiring dialysis at the time of transplant Organ transplant other than liver Pregnant or nursing females Women of childbearing potential not practicing reliable methods of contraception. Reliable methods for contraception include surgical sterilization (hysterectomy, bilateral tubal ligation), double-barrier method (such as condom and diaphragm). To be considered as post-menopausal and not of childbearing potential, female subjects must have experienced 12 consecutive months of amenorrhea. Require any medications that interfere with metabolism of Myfortic (other than corticosteroids) Have a known hypersensitivity to mycophenolate sodium, mycophenolic acid, mycophenolate mofetil, or any of its excipients Participation in a study of investigational drug in the previous 30 days or 5 half-lives of the investigational drug

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cases<br>de novo liver transplant recipients receiving Enteric-coated Mycophenolate Sodium | Drug: Enteric-coated Mycophenolate Sodium<br>* 1440mg/day for 6 months posttransplant<br>* Other names: mycophenolic acid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Twelve hour pharmacokinetics at one week, one month, and six months post transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 week, 1 month, 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myfortic, Mycophenolic acid, Prograf, Tacrolimus, Liver transplantation