Status:
COMPLETED
Myfortic, Prograf, and Corticosteroids in de Novo Liver Transplantation
Lead Sponsor:
R. Mark Ghobrial, MD
Collaborating Sponsors:
Novartis
Conditions:
End Stage Liver Disease
Eligibility:
All Genders
18+ years
Brief Summary
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 r...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01467011
Start Date
December 1 2010
End Date
December 1 2013
Last Update
May 16 2018
Active Locations (1)
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1
The Methodist Hospital System
Houston, Texas, United States, 77030