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

This study has been completed.
Sponsor:
Collaborator:
University of North Carolina
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
NCT00007059
First received: December 6, 2000
Last updated: June 23, 2005
Last verified: December 2003
  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

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
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: NCT00007059

Locations
United States, North Carolina
University of North Carolina School of Medicine
Chapel Hill, North Carolina, United States, 27599-7070
Sponsors and Collaborators
University of North Carolina
Investigators
Study Chair: Robert E. Dupuis University of North Carolina
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00007059     History of Changes
Other Study ID Numbers: NCRR-M01RR00046-1404, UNCCH-GCRC-1404, ROCHE-CEL028
Study First Received: December 6, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

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
Mycophenolate mofetil
Mycophenolic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014