Study of the Pharmacokinetics of Mycophenolate Mofetil in Patients Who Have Undergone Orthotopic Liver Transplantation
NCT ID: NCT00007059
Last Updated: 2005-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
1998-06-30
Brief Summary
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II. Correlate serum concentrations of mycophenolic acid with inosine monophosphate dehydrogenase activity in these patients.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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mycophenolate mofetil
Eligibility Criteria
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Inclusion 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
19 Years
ALL
No
Sponsors
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University of North Carolina
OTHER
National Center for Research Resources (NCRR)
NIH
Principal Investigators
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Robert E. Dupuis
Role: STUDY_CHAIR
University of North Carolina
Locations
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University of North Carolina School of Medicine
Chapel Hill, North Carolina, United States
Countries
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Other Identifiers
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UNCCH-GCRC-1404
Identifier Type: -
Identifier Source: secondary_id
ROCHE-CEL028
Identifier Type: -
Identifier Source: secondary_id
NCRR-M01RR00046-1404
Identifier Type: -
Identifier Source: org_study_id