Ignite Creation Date:
2025-12-24 @ 2:49 PM
Ignite Modification Date:
2026-01-04 @ 7:57 AM
Study NCT ID:
NCT00007059
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Pharmacokinetics of Mycophenolate Mofetil in Patients Who Have Undergone Orthotopic Liver Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D035583', 'term': 'Rare Diseases'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009173', 'term': 'Mycophenolic Acid'}], 'ancestors': [{'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2003-12', 'lastUpdateSubmitDate': '2005-06-23', 'studyFirstSubmitDate': '2000-12-06', 'studyFirstSubmitQcDate': '2000-12-06', 'lastUpdatePostDateStruct': {'date': '2005-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2000-12-07', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['disease-related problem/condition', 'graft versus host disease', 'rare disease'], 'conditions': ['Graft Versus Host Disease']}, 'descriptionModule': {'briefSummary': '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.\n\nII. Correlate serum concentrations of mycophenolic acid with inosine monophosphate dehydrogenase activity in these patients.', 'detailedDescription': 'PROTOCOL OUTLINE:\n\nPatients 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'PROTOCOL ENTRY CRITERIA:\n\n--Disease Characteristics--\n\nOrthotopic liver or kidney transplant recipients who started on a mycophenolate mofetil-containing immunosuppressive regimen within 5 days after transplant\n\nKidney transplant recipients will serve as study controls\n\n--Prior/Concurrent Therapy--\n\n* No concurrent bile acid sequestrants\n* No mycophenolate mofetil as part of rescue therapy regimen\n* No concurrent albumin replacement therapy\n\n--Patient Characteristics--\n\nRenal: Urine output at least 500 mL/day OR Creatinine less than 2.5 mg/dL\n\nOther:\n\n* Not pregnant\n* No mental incompetency\n* No prisoners or parolees HIV negative\n* 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'}, 'identificationModule': {'nctId': 'NCT00007059', 'briefTitle': 'Study of the Pharmacokinetics of Mycophenolate Mofetil in Patients Who Have Undergone Orthotopic Liver Transplantation', 'organization': {'class': 'NIH', 'fullName': 'National Center for Research Resources (NCRR)'}, 'officialTitle': 'Study of the Pharmacokinetics of Mycophenolate Mofetil in Patients Who Have Undergone Orthotopic Liver Transplantation', 'orgStudyIdInfo': {'id': 'NCRR-M01RR00046-1404'}, 'secondaryIdInfos': [{'id': 'UNCCH-GCRC-1404'}, {'id': 'ROCHE-CEL028'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'mycophenolate mofetil', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599-7070', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina School of Medicine', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Robert E. Dupuis', 'role': 'STUDY_CHAIR', 'affiliation': 'University of North Carolina'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Center for Research Resources (NCRR)', 'class': 'NIH'}, 'collaborators': [{'name': 'University of North Carolina', 'class': 'OTHER'}]}}}