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Myfortic, Prograf, and Corticosteroids in de Novo Liver Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01467011
Recruitment Status : Completed
First Posted : November 8, 2011
Last Update Posted : May 16, 2018
Information provided by (Responsible Party):
R. Mark Ghobrial, MD, The Methodist Hospital System

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 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.

Condition or disease Intervention/treatment
End Stage Liver Disease Drug: Enteric-coated Mycophenolate Sodium

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 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.

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Study Type : Observational
Actual Enrollment : 25 participants
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
Study Start Date : December 2010
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Group/Cohort Intervention/treatment
de novo liver transplant recipients receiving Enteric-coated Mycophenolate Sodium
Drug: Enteric-coated Mycophenolate Sodium
1440mg/day for 6 months posttransplant
Other Name: mycophenolic acid

Primary Outcome Measures :
  1. Pharmacokinetic parameters [ Time Frame: Twelve hour pharmacokinetics at one week, one month, and six months post transplant ]
    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.

Secondary Outcome Measures :
  1. Safety and tolerability [ Time Frame: 1 week, 1 month, 6 months ]
    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.

Biospecimen Retention:   Samples Without DNA
Serum will be retained and frozen for MPA levels

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with end stage liver disease who are receiving a liver transplant at The Methodist Hospital in Houston, Texas and who satify the inclusion/exclusion criteria will be considered for the study.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01467011

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United States, Texas
The Methodist Hospital System
Houston, Texas, United States, 77030
Sponsors and Collaborators
R. Mark Ghobrial, MD
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Principal Investigator: R M Ghobrial, MD, PhD The Methodist Hospital System

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Responsible Party: R. Mark Ghobrial, MD, Principal Investigator, The Methodist Hospital System Identifier: NCT01467011    
Other Study ID Numbers: Pro00004722
First Posted: November 8, 2011    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Plan to share data to be determined.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by R. Mark Ghobrial, MD, The Methodist Hospital System:
Mycophenolic acid
Liver transplantation
Additional relevant MeSH terms:
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Mycophenolic Acid
Liver Diseases
End Stage Liver Disease
Digestive System Diseases
Liver Failure
Hepatic Insufficiency
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action