Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:03 AM
Study NCT ID:
NCT00239018
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 on the Efficacy and Safety of Enteric-coated Mycophenolate Sodium Administered in de Novo Kidney Transplant Patients
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': 144}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2005-07', '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': '2005-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess glomerular filtration rate at month 3 post transplantation'}], 'secondaryOutcomes': [{'measure': 'Renal function of patients requiring post transplantation dialysis, experiencing slow graft function (defined as S. Creat level>264 μmol/l at D5) or with immediate graft function.'}, {'measure': 'Incidence of patients requiring post transplantation dialysis, experience slow graft function (defined as S. Creat level>264 μmol/l at D5 or with immediate graft function.'}, {'measure': 'Incidence of biopsy proven acute rejection, any treated acute rejection, and any treated acute rejection requiring antibody therapy, recurrent acute rejection and the severity of acute rejection episodes within 6 and 12 months'}, {'measure': 'Incidence of graft and patient survival within 6 and 12 months'}, {'measure': 'Safety and tolerability based on adverse event (AE) reporting.'}]}, 'conditionsModule': {'keywords': ['Enteric-Coated Mycophenolate Sodium (EC-MPS), de novo, kidney transplantation, long-term safety.'], 'conditions': ['De Novo Kidney Transplantation']}, 'descriptionModule': {'briefSummary': 'The objective of this extension study is to allow patients being treated with enteric-coated mycophenolate sodium (core study CERL080A2405FR01) to continue on the same treatment and to assess the long-term safety of EC-MPS'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion / Exclusion Criteria\n\n\\- All patients who completed study CERL080A2405-FR01 and who are willing to continue treatment with Enteric-Coated Mycophenolate Sodium.\n\nOther protocol-defined inclusion / exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT00239018', 'briefTitle': 'Extension Study on the Efficacy and Safety of Enteric-coated Mycophenolate Sodium Administered in de Novo Kidney Transplant Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Prospective, Open-label, Multicenter, Follow-up Study on the Efficacy and Safety of Enteric-coated Mycophenolate Sodium Administered in de Novo Kidney Transplant Patients', 'orgStudyIdInfo': {'id': 'CERL080A2405FR01E1'}}, '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'}, 'responsibleParty': {'oldNameTitle': 'Novartis', 'oldOrganization': 'Novartis'}}}}