Ignite Creation Date:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-27 @ 11:24 PM
Study NCT ID:
NCT01276834
Status:
TERMINATED
Last Update Posted:
2017-08-07
First Post:
2011-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Immunosuppression on Progression of Arteriosclerosis in Renal Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068338', 'term': 'Everolimus'}], 'ancestors': [{'id': 'D020123', 'term': 'Sirolimus'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'whyStopped': 'insufficient patients enrolled', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-04', 'studyFirstSubmitDate': '2011-01-12', 'studyFirstSubmitQcDate': '2011-01-12', 'lastUpdatePostDateStruct': {'date': '2017-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in coronary artery calcification score', 'timeFrame': '3 years', 'description': 'Comparison in a randomised way the effect of a calcineurin-based immunosuppressive regimen with an mTOR-based regimen on progression of coronary calcification on renal transplant patients.\n\nThe results of this study will provide more insight in protection against cardiovascular disease in renal transplant patients.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Renal Transplantation']}, 'descriptionModule': {'briefSummary': 'To compare in a prospective randomised way the effect of two different immunosuppressive regimens - mTOR-based regimen or CNI-based regimen - on the progression of coronary artery calcification in renal transplant patients measured at baseline, 1, 2, and 3 years after transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18-75 yr\n* Willingness to provide written informed consent\n* Ability to understand the study procedures\n\nExclusion Criteria:\n\n* Life expectancy \\< 3 months\n* Claustrophobia\n* Allergy to iodinated contrast\n* Treatment incompliance\n* Pregnancy\n* Highly HLA-sensitized patients\n* Severe dyslipidemia or proteinuria\n* Severe leucopenia or thrombocytopenia\n* GFR \\< 30 ml/min'}, 'identificationModule': {'nctId': 'NCT01276834', 'acronym': 'NOCTX-2', 'briefTitle': 'Comparison of Immunosuppression on Progression of Arteriosclerosis in Renal Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Dianet Dialysis Centers'}, 'officialTitle': 'Randomised Comparison of Two Different Immunosuppressive Regimens on Progression of Arteriosclerosis in Renal Transplant Patients.', 'orgStudyIdInfo': {'id': 'NOCTX-2'}, 'secondaryIdInfos': [{'id': '2009-011605-16', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'everolimus-based immunosuppression', 'description': 'immunosuppression with everolimus, prednisone and mycophenolate', 'interventionNames': ['Drug: everolimus']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'standard immunosuppression', 'description': 'immunosuppression with tacrolimus, prednisone and mycophenolate', 'interventionNames': ['Drug: everolimus']}], 'interventions': [{'name': 'everolimus', 'type': 'DRUG', 'description': 'comparison of everolimus-based and CNI-based immunosuppression', 'armGroupLabels': ['everolimus-based immunosuppression', 'standard immunosuppression']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3584 CX', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'University Medical Center Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'overallOfficials': [{'name': 'Franka E van Reekum, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMC Utrecht'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dianet Dialysis Centers', 'class': 'OTHER'}, 'collaborators': [{'name': 'UMC Utrecht', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'B.C. van Jaarsveld, MD PhD', 'investigatorAffiliation': 'Dianet Dialysis Centers'}}}}