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Study of the Pharmacokinetics of Mycophenolate Mofetil in Patients Who Have Undergone Orthotopic Liver Transplantation

Sponsor
National Center for Research Resources (NCRR) (NIH)
Overall Status
Completed
CT.gov ID
NCT00007059
Collaborator
University of North Carolina (Other)
20
Enrollment
1
Location

Study Details

Study Description

Brief Summary

OBJECTIVES: I. Determine the effects of bile externalization and antibiotic gut sterilization on the pharmacokinetics of mycophenolate mofetil in patients who have undergone orthotopic liver transplantation.

  1. Correlate serum concentrations of mycophenolic acid with inosine monophosphate dehydrogenase activity in these patients.
Condition or Disease Intervention/Treatment Phase
  • Drug: mycophenolate mofetil
 N/A

Detailed Description

PROTOCOL OUTLINE:

Patients begin a mycophenolate mofetil (MMF)-containing regimen within the first 5 days after transplantation. Patients have blood drawn on postoperative days 7, 21, 42, 70, 98, 126, and 154. Urine is collected on postoperative days 7, 21, and 42. Patients with T-tube bile externalization also have bile collected on postoperative day 7.

Study Design

Study Type:
Interventional
Primary Purpose:
Treatment
Official Title:
Study of the Pharmacokinetics of Mycophenolate Mofetil in Patients Who Have Undergone Orthotopic Liver Transplantation
Study Start Date :
Jun 1, 1998

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    PROTOCOL ENTRY CRITERIA:

    --Disease Characteristics--

    Orthotopic liver or kidney transplant recipients who started on a mycophenolate mofetil-containing immunosuppressive regimen within 5 days after transplant

    Kidney transplant recipients will serve as study controls

    --Prior/Concurrent Therapy--

    • No concurrent bile acid sequestrants

    • No mycophenolate mofetil as part of rescue therapy regimen

    • No concurrent albumin replacement therapy

    --Patient Characteristics--

    Renal: Urine output at least 500 mL/day OR Creatinine less than 2.5 mg/dL

    Other:

    • Not pregnant

    • No mental incompetency

    • No prisoners or parolees HIV negative

    • No active infection defined as: Temperature above 101 F with WBC greater than 12,000/mm3 and left shift OR Two or more positive cultures of a single isolated organism from blood, urine, or sputum

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of North Carolina School of Medicine Chapel Hill North Carolina United States 27599-7070

    Sponsors and Collaborators

    • National Center for Research Resources (NCRR)
    • University of North Carolina

    Investigators

    • Study Chair: Robert E. Dupuis, University of North Carolina

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00007059
    Other Study ID Numbers:
    • NCRR-M01RR00046-1404
    • UNCCH-GCRC-1404
    • ROCHE-CEL028
    First Posted:
    Dec 7, 2000
    Last Update Posted:
    Jun 24, 2005
    Last Verified:
    Dec 1, 2003
    Keywords provided by , ,
    disease-related problem/condition
    graft versus host disease
    rare disease
    Additional relevant MeSH terms:
    Graft vs Host Disease
    Mycophenolic Acid

    Study Results

    No Results Posted as of Jun 24, 2005