Ignite Creation Date:
2025-12-24 @ 3:37 PM
Ignite Modification Date:
2025-12-25 @ 6:42 PM
Study NCT ID:
NCT00238992
Status:
COMPLETED
Last Update Posted:
2011-11-02
First Post:
2005-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Enteric-coated Mycophenolate Sodium (EC-MPS) With Steroid Withdrawal vs EC-MPS With Standard Steroid Regimen in de Novo Renal Transplant Recipients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 144}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-11', 'lastUpdateSubmitDate': '2011-11-01', 'studyFirstSubmitDate': '2005-10-12', 'studyFirstSubmitQcDate': '2005-10-12', 'lastUpdatePostDateStruct': {'date': '2011-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-10-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'biopsy proven acute rejection incidence at 1 year post-transplantation'}], 'secondaryOutcomes': [{'measure': 'Incidence of biopsy proven acute rejection episodes at 6 months'}, {'measure': 'Incidence of treated rejection episodes at 6 months and 1 year'}, {'measure': 'Incidence of steroid-resistant episodes at 6 months and 1 year'}, {'measure': 'Patient and graft survival at 1 year'}, {'measure': 'Cardiovascular profile (as measured by Cholesterol, HbA1, Glucose, incidence of HTA)'}, {'measure': 'Percentage of patients free from steroids at 6 months and 1 year'}, {'measure': 'Treatment safety'}]}, 'conditionsModule': {'keywords': ['Kidney, de novo transplant, steroid withdrawal, adults, EC-MPS and cyclosporine'], 'conditions': ['Kidney de Novo Transplant']}, 'descriptionModule': {'briefSummary': 'All patients of the core study who are interested of being treated with EC-MPS will be included in an open-label extension study to collect further information on the long-term safety, tolerability and efficacy of this drug.\n\nThe purpose of this study is to evaluate the feasibility of steroid withdrawal in the setting of immunosuppression with a combination of EC-MPS, cyclosporine and steroids in de novo kidney allograft recipients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria\n\n* Male or female patients undergoing first kidney transplant.\n* Patients aged 18 -70 years.\n* Patients receiving an ABO identical or compatible graft. Exclusion Criteria\n* Multi-organ recipients (e.g. kidney and pancreas) or previous transplant with any organ other than kidney.\n* Positive HBsAg test\n* Pre-Transplant PRA \\>50% or historical PRA \\>75% Other protocol-defined inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00238992', 'briefTitle': 'Study of Enteric-coated Mycophenolate Sodium (EC-MPS) With Steroid Withdrawal vs EC-MPS With Standard Steroid Regimen in de Novo Renal Transplant Recipients.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Prospective, Randomized, Open Label, Multicenter Trial of EC-MPS With Steroid Withdrawal vs EC-MPS With Standard Steroid Regimen for the Prevention of Acute Rejection Episodes in de Novo Renal Transplant Recipients.', 'orgStudyIdInfo': {'id': 'CERL080A2405ES01'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Enteric-coated Mycophenolate sodium (EC-MPS)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Novartis', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}