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

Graft Versus Host Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00007059
• Other study ID #: NCRR-M01RR00046-1404
• Secondary ID: UNCCH-GCRC-1404R
• Status: Completed
• Phase: N/A
• First received: December 6, 2000
• Last updated: June 23, 2005
• Start date: June 1998

Study information

• Verified date: December 2003
• Source: National Center for Research Resources (NCRR)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Graft Versus Host Disease
• Graft vs Host Disease

Intervention

Drug:
• mycophenolate mofetil

Locations

Country	Name	City	State
United States	University of North Carolina School of Medicine	Chapel Hill	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
National Center for Research Resources (NCRR)	University of North Carolina

Country where clinical trial is conducted

United States,