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

NCT00007059 | Completed

• 3 other identifiers: NCRR-M01RR00046-1404UNCCH-GCRC-1404ROCHE-CEL028
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

Graft Versus Host Disease

Keywords

disease-related problem/condition; graft versus host disease; rare disease

Interventions

mycophenolate mofetil DRUG

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

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

Study Sites (1)

University of North Carolina School of Medicine

Chapel Hill, North Carolina, 27599-7070, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease; Rare Diseases

Interventions

Mycophenolic Acid

Condition Hierarchy (Ancestors)

Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids

Study Officials

• Robert E. Dupuis

  University of North Carolina

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: December 6, 2000
• First Posted: December 7, 2000
• Study Start: June 1, 1998
• Last Updated: June 24, 2005

Record last verified: 2003-12

Locations

US (1)