Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2025-12-25 @ 2:23 PM
Study NCT ID:
NCT00238966
Status:
COMPLETED
Last Update Posted:
2011-01-31
First Post:
2005-10-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Extension Study to Assess Tolerability and Safety of Enteric-coated Mycophenolate Sodium in Renal Transplant Recipients Who Received Mycophenolate Mofetil
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 187}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2005-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-28', 'studyFirstSubmitDate': '2005-10-12', 'studyFirstSubmitQcDate': '2005-10-12', 'lastUpdatePostDateStruct': {'date': '2011-01-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety/tolerability based on adverse events within 6 months after switching patients from MMF to optimized enteric-coated mycophenolate sodium.'}], 'secondaryOutcomes': [{'measure': 'Safety based on renal function within 6 months after medication switch.'}, {'measure': 'Pharmacokinetics (PK) in a randomized subpopulation.'}, {'measure': 'Efficacy measured by the incidence of biopsy-proven acute rejection, graft loss or death within 6 months post medication switch.'}, {'measure': 'Efficacy measured by the incidence of biopsy-proven acute rejection 6 months post medication switch.'}, {'measure': 'Graft survival and patient survival 6 months post medication switch.'}]}, 'conditionsModule': {'keywords': ['Renal transplantation, Enteric-Coated Mycophenolate Sodium (EC-MPS)'], 'conditions': ['Renal Transplantation']}, 'descriptionModule': {'briefSummary': 'This extension study is considered to allow patients being treated with EC-MPS to collect further information on the long-term safety of this drug.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion/ Exclusion criteria\n\n\\- Only patients who were participating in study CERL080A2405-DE02 and have completed the first 6 months of the core study can be included in this additional extension study.\n\nOther protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00238966', 'briefTitle': 'Extension Study to Assess Tolerability and Safety of Enteric-coated Mycophenolate Sodium in Renal Transplant Recipients Who Received Mycophenolate Mofetil', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A One Arm, Open-label Study to Investigate the Tolerability and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Renal Transplant Recipients Who Received Mycophenolate Mofetil (MMF)', 'orgStudyIdInfo': {'id': 'CERL080A2405DE02E1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Enteric-Coated Mycophenolate Sodium (EC-MPS)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Novartis', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}}}}