Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2026-01-03 @ 7:38 PM
Study NCT ID:
NCT00241059
Status:
COMPLETED
Last Update Posted:
2011-01-31
First Post:
2005-10-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Extension Study of the Safety and Efficacy of Enteric-coated Mycophenolate Sodium in Kidney Transplant Recipients
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': 183}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-28', 'studyFirstSubmitDate': '2005-10-14', 'studyFirstSubmitQcDate': '2005-10-14', 'lastUpdatePostDateStruct': {'date': '2011-01-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety parameters and graft function in maintenance renal transplant recipients.'}], 'secondaryOutcomes': [{'measure': 'Incidence of acute rejection episodes and graft survival in maintenance renal transplant recipients.'}]}, 'conditionsModule': {'keywords': ['Renal transplantation, maintenance patients, tolerability, EC-MPS'], 'conditions': ['Renal Transplantation']}, 'descriptionModule': {'briefSummary': 'The objective of this extension study is to allow patients being treated with enteric-coated mycophenolate sodium (core study CERL080A2405LA01) to continue on the same treatment and to assess the long-term safety of EC-MPS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients who completed study CERL080A2405-LA01 and who are willing to continue treatment with Enteric-Coated Mycophenolate Sodium.\n\nExclusion Criteria:\n\n* Other protocol-defined inclusion / exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00241059', 'briefTitle': 'Extension Study of the Safety and Efficacy of Enteric-coated Mycophenolate Sodium in Kidney Transplant Recipients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Prospective, Open-label, Multicenter, International Follow-up Study on the Safety and Efficacy of Enteric-coated Mycophenolate Sodium (EC-MPS) in Kidney Transplant Recipients', 'orgStudyIdInfo': {'id': 'CERL080A2405LA01E1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'EC-MPS arm', 'interventionNames': ['Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)']}], 'interventions': [{'name': 'Enteric-Coated Mycophenolate Sodium (EC-MPS)', 'type': 'DRUG', 'armGroupLabels': ['EC-MPS arm']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'External Affairs', 'oldOrganization': 'Novartis Pharmaceticals'}}}}