Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2025-12-27 @ 7:05 AM
Study NCT ID:
NCT00171392
Status:
COMPLETED
Last Update Posted:
2011-02-02
First Post:
2005-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study to Evaluate the Tolerability, Safety and Efficacy of Enteric-coated Mycophenolate Sodium, After Equimolar Conversion From Mycophenolate Mofetil (MMF), in Patients With Stable Renal Transplant Receiving Tacrolimus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 132}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-01', 'studyFirstSubmitDate': '2005-09-12', 'studyFirstSubmitQcDate': '2005-09-12', 'lastUpdatePostDateStruct': {'date': '2011-02-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Renal function, measured as calculated creatinine clearance according to the Cockcroft and Gault formula'}], 'secondaryOutcomes': [{'measure': 'Incidence of biopsy proven acute rejection'}, {'measure': 'Overall Gastrointestinal disturbances as measured by visual analog scales (upper and lower gastrointestinal symptoms)'}, {'measure': 'Quality of life related to GI symptoms (GIQLI scale)'}, {'measure': 'Full blood count'}, {'measure': 'Gastrointestinal Adverse Events (check-list)'}]}, 'conditionsModule': {'keywords': ['Kidney transplantation; acute rejection; gastrointestinal adverse events; quality of life; mycophenolate sodium, tacrolimus.'], 'conditions': ['Prevention of Acute Rejection After Kidney Transplantation']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to assess the safety and efficacy of enteric-coated mycophenolate sodium, given in combination with tacrolimus, after equimolar dose conversion from MMF to enteric-coated mycophenolate sodium in stable renal transplant patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First or second (single or double) deceased or living donor kidney/kidney-pancreas transplant received at least six months previously;\n* Immunosuppressive therapy with tacrolimus and mycophenolate mofetil (MMF);\n\nExclusion Criteria:\n\nSubjects expected to discontinue tacrolimus therapy;\n\n* Patients with thrombocytopenia (\\<75,000/mm3), an absolute neutrophil count of \\<1,500/mm3 and/or leukopenia (\\<2,500/mm3), or anemia (hemoglobin \\<6 g/dl) at baseline;\n* Patients experiencing an acute rejection in the previous two months, with inadequate (creatininemia \\>2.5 mg/dL) or worsening renal function in the previous two months.'}, 'identificationModule': {'nctId': 'NCT00171392', 'briefTitle': 'Clinical Study to Evaluate the Tolerability, Safety and Efficacy of Enteric-coated Mycophenolate Sodium, After Equimolar Conversion From Mycophenolate Mofetil (MMF), in Patients With Stable Renal Transplant Receiving Tacrolimus', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Open-label Study to Evaluate the Tolerability, Safety and Efficacy of the Equimolar Conversion From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium in Patients With Stable Renal Transplant Receiving Tacrolimus', 'orgStudyIdInfo': {'id': 'CERL080AIT02'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Enteric-coated mycophenolate sodium', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Novartis', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Novartis External Affairs', 'oldOrganization': 'Novartis Pharmaceuticals'}}}}