Ignite Creation Date:
2025-12-24 @ 9:45 PM
Ignite Modification Date:
2025-12-25 @ 7:25 PM
Study NCT ID:
NCT00402532
Status:
COMPLETED
Last Update Posted:
2011-12-08
First Post:
2006-11-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immunosuppressive Therapy With Certican (Everolimus) After Lung Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D009894', 'term': 'Opportunistic Infections'}], 'ancestors': [{'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068338', 'term': 'Everolimus'}, {'id': 'D009173', 'term': 'Mycophenolic Acid'}], 'ancestors': [{'id': 'D020123', 'term': 'Sirolimus'}, {'id': 'D018942', 'term': 'Macrolides'}, {'id': 'D007783', 'term': 'Lactones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002208', 'term': 'Caproates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 190}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-07', 'studyFirstSubmitDate': '2006-11-20', 'studyFirstSubmitQcDate': '2006-11-20', 'lastUpdatePostDateStruct': {'date': '2011-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-11-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of bronchiolitis obliterans syndrome and mortality and need for change of immunosuppressive medication within 2 years from transplantation', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Incidence and severity of Nephrotoxicity within 2 years of transplantation', 'timeFrame': '2 years'}, {'measure': 'Incidence and severity of opportunistic infections within 2 years of transplantation', 'timeFrame': '2 years'}]}, 'conditionsModule': {'keywords': ['Lung Transplantation', 'Immunosuppression', 'Mortality', 'Graft rejection', 'Bronchiolitis obliterans', 'Opportunistic infections', 'Nephrotoxicity'], 'conditions': ['Lung Transplantation']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Everolimus is effective in the treatment and prevention of chronic graft dysfunction and chronic graft rejection after lung transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Recipient of Single or Bilateral Lung Transplantation\n* Informed consent\n* Recipients who are able to receive Everolimus at week 3 after Lung Transplantation\n* women of childbearing potential must have a negative pregnancy test within 48 hours of enrolment\n* women of childbearing potential must use appropriate contraceptive method at enrolment, during the study and up to 8 weeks after the end of the study\n* donor must not have relevant pulmonary diseases\n* donor must have oxygen partial pressure higher than 300 mmHg at FiO 1.0 and positive end-expiratory pressure of 5 cm H2O.\n\nExclusion Criteria:\n\n* systemic infection of the donor\n* donor: signs or symptoms of aspiration\n* donor: severe pulmonary injury or contusion\n* donor: malignant neoplasm of the lung\n* donor: HIV positive\n* recipients who receive immunosuppressive agents not used in this protocol\n* recipients who participated within 30 days before study start or are currently participating in another investigational drug trial\n* HIV positive recipient\n* systemic infection of the recipient\n* recipients of combined/ multiple transplantations\n* pregnancy of the recipient\n* recipients with signs/ Symptoms of impaired wound healing of the pulmonary anastomoses\n* recipients who are still on artificial respiration or who are not able to swallow tablets at week 3 after transplantation'}, 'identificationModule': {'nctId': 'NCT00402532', 'briefTitle': 'Immunosuppressive Therapy With Certican (Everolimus) After Lung Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Hannover Medical School'}, 'officialTitle': 'Immunosuppressive Therapy With Certican (Everolimus) After Lung Transplantation', 'orgStudyIdInfo': {'id': 'Ever-Lung-DE01/RAD-LungDE01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Everolimus', 'interventionNames': ['Drug: Everolimus']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mycophenolatmofetil', 'interventionNames': ['Drug: Mycophenolatmofetil']}], 'interventions': [{'name': 'Everolimus', 'type': 'DRUG', 'otherNames': ['Certican'], 'description': 'Initial dosage 2 x 0.75 mg/d', 'armGroupLabels': ['Everolimus']}, {'name': 'Mycophenolatmofetil', 'type': 'DRUG', 'otherNames': ['Cellcept'], 'description': 'Initial dosage 2 x 500 mg/d intravenous', 'armGroupLabels': ['Mycophenolatmofetil']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30625', 'city': 'Hanover', 'country': 'Germany', 'facility': 'Hannover Medical School, Division of Thoracic and Cardiovascular Surgery', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}], 'overallOfficials': [{'name': 'Martin Strueber, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hannover Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hannover Medical School', 'class': 'OTHER'}, 'collaborators': [{'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Martin Strueber, MD', 'investigatorFullName': 'Martin Strueber', 'investigatorAffiliation': 'Hannover Medical School'}}}}