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

This study has been completed.

First Received: December 6, 2000 Last Updated: June 23, 2005 History of Changes

Sponsors and Collaborators:	National Center for Research Resources (NCRR) University of North Carolina
Information provided by:	National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:	NCT00007059

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

MedlinePlus related topics: Liver Transplantation

Drug Information available for: Mycophenolate mofetil hydrochloride Mycophenolate Mofetil

U.S. FDA Resources

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

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

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

National Center for Research Resources (NCRR)

University of North Carolina

Investigators

Study Chair:

Robert E. Dupuis

University of North Carolina

More Information

No publications provided

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

Study placed in the following topic categories:

Graft Versus Host Disease
Anti-Bacterial Agents
Immunologic Factors
Mycophenolic Acid
Mycophenolate mofetil

Rare Diseases
Graft vs Host Disease
Immunosuppressive Agents
Homologous Wasting Disease

Additional relevant MeSH terms:

Immune System Diseases
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Mycophenolic Acid
Enzyme Inhibitors

Antibiotics, Antineoplastic
Immunosuppressive Agents
Pharmacologic Actions
Therapeutic Uses
Mycophenolate mofetil
Graft vs Host Disease

ClinicalTrials.gov processed this record on May 06, 2009