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

December 6, 2000
June 23, 2005
June 1998
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Complete list of historical versions of study NCT00007059 on ClinicalTrials.gov Archive Site
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Study of the Pharmacokinetics of Mycophenolate Mofetil in Patients Who Have Undergone Orthotopic Liver Transplantation
Study of the Pharmacokinetics of Mycophenolate Mofetil in Patients Who Have Undergone Orthotopic Liver Transplantation

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.

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.

Interventional
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Primary Purpose: Treatment
Graft Versus Host Disease
Drug: mycophenolate mofetil
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
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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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00007059
NCRR-M01RR00046-1404, UNCCH-GCRC-1404, ROCHE-CEL028
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National Center for Research Resources (NCRR)
University of North Carolina
Study Chair: Robert E. Dupuis University of North Carolina
National Center for Research Resources (NCRR)
December 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP