Myfortic, Prograf, and Corticosteroids in de Novo Liver Transplantation

May 11, 2018 updated by: R. Mark Ghobrial, MD

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The Methodist Hospital System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

R. Mark Ghobrial, MD

Collaborators

Novartis

Investigators

  • Principal Investigator: R M Ghobrial, MD, PhD, The Methodist Hospital Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

November 1, 2011

First Submitted That Met QC Criteria

November 7, 2011

First Posted (Estimate)

November 8, 2011

Study Record Updates

Last Update Posted (Actual)

May 16, 2018

Last Update Submitted That Met QC Criteria

May 11, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00004722

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Plan to share data to be determined.

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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