Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2026-02-12 @ 5:45 AM
Study NCT ID:
NCT02876250
Status:
WITHDRAWN
Last Update Posted:
2019-03-14
First Post:
2016-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Postconditioning by Cyclosporin A in Pulmonary Transplantation
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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-03-13', 'studyFirstSubmitDate': '2016-08-18', 'studyFirstSubmitQcDate': '2016-08-18', 'lastUpdatePostDateStruct': {'date': '2019-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PaO2/FiO2 ratio (ratio of arterial oxygen partial pressure to fractional inspired oxygen)', 'timeFrame': '2 hours post-lung transplantation'}, {'measure': 'PaO2/FiO2 ratio', 'timeFrame': '6 hours post-lung transplantation'}, {'measure': 'PaO2/FiO2 ratio', 'timeFrame': '12 hours post-lung transplantation'}, {'measure': 'PaO2/FiO2 ratio', 'timeFrame': '18 hours post-lung transplantation'}, {'measure': 'PaO2/FiO2 ratio', 'timeFrame': '24 hours post-lung transplantation'}, {'measure': 'PaO2/FiO2 ratio', 'timeFrame': '36 hours post-lung transplantation'}, {'measure': 'PaO2/FiO2 ratio', 'timeFrame': '48 hours post-lung transplantation'}, {'measure': 'PaO2/FiO2 ratio', 'timeFrame': '60 hours post-lung transplantation'}, {'measure': 'PaO2/FiO2 ratio', 'timeFrame': '72 hours post-lung transplantation'}], 'secondaryOutcomes': [{'measure': 'primary graft failure grade', 'timeFrame': '72 hours', 'description': 'clinical status of primary graft failure at 72 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lung transplantation', 'Cyclosporine', 'Postconditioning'], 'conditions': ['Lung Transplantation']}, 'descriptionModule': {'briefSummary': "The morbidity and mortality of patients undergoing lung transplantation in the acute phase following surgical intervention is mainly due to the primary graft failure (PGF).\n\nThe occurrence of PGF is multi factorial but is mainly caused by ischemia-reperfusion injury. The pulmonary graft suffers two periods of ischemia one when it is explanted from the donor (cold ischemia) followed by another when it is grafted into the recipient's thoracic cavity (warm ischemia). The brutal reperfusion of the graft exposes it to reperfusion injury that causes PGF. PGF occurs in up to 20% of transplanted patients and is associated with significantly higher levels of 30-days all-cause mortality. Patients with PGF have a 40% mortality at 30-days versus a 6% mortality in patients without PGF.\n\nIschemic postconditioning, has recently been described in experimental models of ischemia-reperfusion injury in the heart, and although not yet fully understood. Several studies suggest that the mitochondria play a central role in cellular survival mechanisms after a prolonged period of ischemia-reperfusion (with the mitochondrial permeability transition pore (mPTP)).\n\nExperimental studies have shown that cyclosporin A (CsA) administered prior to reperfusion binds to cyclophilin D and blocks the opening of mPTP after reperfusion. This protective effect of ischemia-reperfusion injury by CsA has been shown in experimental studies and in clinical phase II trials in reperfused myocardial infarction patients.\n\nThe hypothesis of this study is that the administration of CsA in transplanted patients (before re-opening of the first pulmonary graft vessels) protects the transplanted lung(s) from the deleterious effects of ischemia-reperfusion injury and thus reduce the frequency and severity of PGF."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients over 18 years old, man or woman, who are listed for pulmonary transplantation either mono or double lung transplantation.\n\nExclusion Criteria:\n\n* No contra-indication to CsA administration.'}, 'identificationModule': {'nctId': 'NCT02876250', 'acronym': 'CsA Poumon', 'briefTitle': 'Postconditioning by Cyclosporin A in Pulmonary Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Postconditioning by Cyclosporin A in Pulmonary Transplantation', 'orgStudyIdInfo': {'id': '2013-816'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cyclosporine A', 'description': 'a pharmacological postconditioned group with IV administration of 2.5 mg/kg of CsA prior to first graft reperfusion', 'interventionNames': ['Drug: Cyclosporine A']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'a control group with IV administration of 2.5 mg/kg of placebo prior to first graft reperfusion', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Cyclosporine A', 'type': 'DRUG', 'description': 'a pharmacological postconditioned group with IV administration of 2.5 mg/kg of CsA prior to first graft reperfusion', 'armGroupLabels': ['Cyclosporine A']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'a control group with IV administration of 2.5 mg/kg of placebo prior to first graft reperfusion', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bron', 'country': 'France', 'facility': 'Hôpital Louis Pradel', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}], 'overallOfficials': [{'name': 'François TRONC, Pr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospices Civils de Lyon'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}