Myfortic, Prograf, and Corticosteroids in de Novo Liver Transplantation

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
R. Mark Ghobrial, MD, The Methodist Hospital System
ClinicalTrials.gov Identifier:
NCT01467011
First received: November 1, 2011
Last updated: February 21, 2014
Last verified: February 2014
  Purpose

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 Phase
End Stage Liver Disease
Phase 4

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by The Methodist Hospital System:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 25
Study Start Date: December 2010
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01467011

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

No publications provided

Responsible Party: R. Mark Ghobrial, MD, Principal Investigator, The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT01467011     History of Changes
Other Study ID Numbers: Myfortic with Prograf
Study First Received: November 1, 2011
Last Updated: February 21, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by The Methodist Hospital System:
Myfortic
Mycophenolic acid
Prograf
Tacrolimus
Liver transplantation

Additional relevant MeSH terms:
Liver Diseases
End Stage Liver Disease
Digestive System Diseases
Liver Failure
Hepatic Insufficiency
Mycophenolic Acid
Mycophenolate mofetil
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 18, 2014