Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-01 @ 9:18 AM
Study NCT ID:
NCT00788567
Status:
COMPLETED
Last Update Posted:
2015-11-03
First Post:
2008-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CLEAR Study - A Study of CellCept (Mycophenolate Mofetil) in Recipients of Kidney Transplants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-02', 'studyFirstSubmitDate': '2008-11-10', 'studyFirstSubmitQcDate': '2008-11-10', 'lastUpdatePostDateStruct': {'date': '2015-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients achieving therapeutic window by Day 5\\n'}], 'secondaryOutcomes': [{'measure': 'Efficacy: Achieving therapeutic window at Day 3, maintaining therapeutic window at day of discharge, Months 1, 3, and 6\\nSafety: Renal function, opportunistic infections, malignancies, and adverse events\\n'}]}, 'conditionsModule': {'conditions': ['Kidney Transplantation']}, 'referencesModule': {'references': [{'pmid': '20498245', 'type': 'DERIVED', 'citation': 'Gourishankar S, Houde I, Keown PA, Landsberg D, Cardella CJ, Barama AA, Dandavino R, Shoker A, Pirc L, Wrobel MM, Kiberd BA. The CLEAR study: a 5-day, 3-g loading dose of mycophenolate mofetil versus standard 2-g dosing in renal transplantation. Clin J Am Soc Nephrol. 2010 Jul;5(7):1282-9. doi: 10.2215/CJN.09091209. Epub 2010 May 24.'}]}, 'descriptionModule': {'briefSummary': 'This study will compare the efficacy and safety of 2 dosing regimens of oral CellCept administered as a component of standard immunosuppressive therapy in recipients of kidney transplants. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients \\>=18 years of age;\n* recipients of a primary kidney transplant.\n\nExclusion Criteria:\n\n* positive for HIV-1, human T-cell leukemia/lymphoma virus-1 (HTLV-1), or hepatitis B surface antigen;\n* positive for hepatitis C virus, with moderate or severe liver disease;\n* active malignancy or history of malignancy, excluding skin cancer (basal or squamous cell) that has been adequately treated;\n* need for maintenance corticosteroids for another condition.'}, 'identificationModule': {'nctId': 'NCT00788567', 'briefTitle': 'CLEAR Study - A Study of CellCept (Mycophenolate Mofetil) in Recipients of Kidney Transplants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Randomized, Open-label Study of the Achievement of a Mycophenolic Acid Therapeutic Window During Treatment With 2 Dosing Regimens of Oral CellCept Administered as a Component of Standard Immunosuppressive Therapy in Patients With Kidney Transplants', 'orgStudyIdInfo': {'id': 'ML18496'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: mycophenolate mofetil']}], 'interventions': [{'name': 'mycophenolate mofetil', 'type': 'DRUG', 'otherNames': ['CellCept'], 'description': '1', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6G 2S2', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'V5Z 1M9', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'V6Z 1Y6', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'B3H2Y9', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'M5G 2C4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'H1T 2M4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H2L 4M1', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'G1R 2J6', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'zip': 'S7N 0W8', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_CHAIR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}