Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT00154193
Status:
COMPLETED
Last Update Posted:
2020-02-11
First Post:
2005-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nordic Study in Cardiac and Lung Transplantation: Outcome in Relation to Cyclosporine Microemulsion C2 Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016572', 'term': 'Cyclosporine'}], 'ancestors': [{'id': 'D003524', 'term': 'Cyclosporins'}, {'id': 'D010456', 'term': 'Peptides, Cyclic'}, {'id': 'D047028', 'term': 'Macrocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 190}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'lastUpdateSubmitDate': '2020-02-08', 'studyFirstSubmitDate': '2005-09-06', 'studyFirstSubmitQcDate': '2005-09-06', 'lastUpdatePostDateStruct': {'date': '2020-02-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The average number of treated acute cardiac and lung graft rejection per patient during the first 12 months post transplant'}, {'measure': 'The measured Glomerular Filtration Rate (GFR) at 3 and 12 months post-transplant'}], 'secondaryOutcomes': [{'measure': 'Incidence of treated acute rejections'}, {'measure': 'Incidence of biopsy-proven acute cellular rejections'}, {'measure': 'Patient and Graft survival rates'}]}, 'conditionsModule': {'keywords': ['Heart transplant, lung transplant, renal function, cyclosporine C2 Levels'], 'conditions': ['Heart and Lung Transplant']}, 'referencesModule': {'references': [{'pmid': '19716045', 'type': 'DERIVED', 'citation': 'Iversen M, Nilsson F, Sipponen J, Eiskjaer H, Mared L, Bergan S, Nystrom U, Fagertun HE, Solbu D, Simonsen S. Cyclosporine C2 levels have impact on incidence of rejection in de novo lung but not heart transplant recipients: the NOCTURNE study. J Heart Lung Transplant. 2009 Sep;28(9):919-26. doi: 10.1016/j.healun.2009.05.022.'}]}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to identify cyclosporine C2 levels during 12 months treatment , while cyclosporine microemulsion dosages are adjusted based on C0 cyclosporine blood samples, and retrospectively correlate C2 levels to outcome (renal function and incidence of acute rejections)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients receiving a first heart or bilateral or single lung transplant\n* Patients for whom a triple maintenance immunosuppressive therapy consisting of cyclosporine microemulsion, steroids and mycophenolate mofetil (MMF)/ enteric-coated mycophenolate sodium (EC-MPS ,(or azathioprine) is indicated.\n\nExclusion Criteria:\n\n* Multi-organ transplants or previously transplanted organs\n* Patients with the need of more than two cyclosporine microemulsion dosages per day\n\nOther protocol-defined inclusion/exclusion criteria may applied'}, 'identificationModule': {'nctId': 'NCT00154193', 'briefTitle': 'Nordic Study in Cardiac and Lung Transplantation: Outcome in Relation to Cyclosporine Microemulsion C2 Levels', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 12-month Study to Investigate the Correlations Between Cyclosporine Microemulsion C2 Levels (High, Medium and Low) and AUC0-4 With Regard to Outcome in de Novo Heart and Lung Transplantation - Identification of Target Cyclosporine Microemulsion C2 Levels.', 'orgStudyIdInfo': {'id': 'COLO400ANO01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cyclosporine', 'interventionNames': ['Drug: cyclosporine']}], 'interventions': [{'name': 'cyclosporine', 'type': 'DRUG', 'description': 'patients will receive maintenance triple immunosuppression according to local practice consisting of Sandimmun Neoral, MMF/ECMPA or azathioprin and steroids.', 'armGroupLabels': ['Cyclosporine']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Basel', 'country': 'Switzerland', 'facility': 'Novartis', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Novartis', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}