Myfortic, Prograf, and Corticosteroids in de Novo Liver Transplantation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

25 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-12-31

Study Completion Date

2013-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Enteric Coated Myfortic for Liver Transplant Recipients

NCT00167492

Liver Transplantation

WITHDRAWN PHASE4

A Study to Compare Safety and Efficacy of Prograf + Myfortic and Advagraf + Myfortic in Liver Transplantation Patients

NCT01018914

Liver Transplantation

COMPLETED PHASE4

Myfortic Conversion Trial in OLT Recipients With GI Intolerance

NCT00619216

GI Disturbance

COMPLETED

A Prospective Study on the Tolerability and Efficacy of the de Novo Use of Myfortic in Liver Transplant Recipients

NCT00336817

Immunosuppression

COMPLETED NA

Enteric-coated Mycophenolate Sodium (Myfortic®) in Heart Transplant Recipients

NCT00574197

Gastrointestinal Symptoms Heart Transplantation

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

End Stage Liver Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cases

de novo liver transplant recipients receiving Enteric-coated Mycophenolate Sodium

Enteric-coated Mycophenolate Sodium

Intervention Type DRUG

1440mg/day for 6 months posttransplant

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Enteric-coated Mycophenolate Sodium

1440mg/day for 6 months posttransplant

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

mycophenolic acid

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No