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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00007059
First Posted: December 7, 2000
Last Update Posted: December 9, 2005
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.
Collaborator:
University of North Carolina
Information provided by:
National Center for Research Resources (NCRR)
  Purpose

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.

II. Correlate serum concentrations of mycophenolic acid with inosine monophosphate dehydrogenase activity in these patients.


Condition Intervention
Graft Versus Host Disease Drug: mycophenolate mofetil

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Study of the Pharmacokinetics of Mycophenolate Mofetil in Patients Who Have Undergone Orthotopic Liver Transplantation

Resource links provided by NLM:


Further study details as provided by National Center for Research Resources (NCRR):

Estimated Enrollment: 20
Study Start Date: June 1998
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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 ClinicalTrials.gov identifier (NCT number): NCT00007059


Locations
United States, North Carolina
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
  More Information

ClinicalTrials.gov Identifier: NCT00007059     History of Changes
Other Study ID Numbers: NCRR-M01RR00046-1404
UNCCH-GCRC-1404
ROCHE-CEL028
First Submitted: December 6, 2000
First Posted: December 7, 2000
Last Update Posted: December 9, 2005
Last Verified: December 2003

Keywords provided by National Center for Research Resources (NCRR):
disease-related problem/condition
graft versus host disease
rare disease

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Mycophenolic Acid
Antibiotics, Antineoplastic
Antineoplastic Agents
Antibiotics, Antitubercular
Antitubercular Agents
Anti-Bacterial Agents
Anti-Infective Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action