Ignite Creation Date:
2025-12-24 @ 2:16 PM
Ignite Modification Date:
2026-04-16 @ 1:24 AM
Study NCT ID:
NCT02897895
Status:
UNKNOWN
Last Update Posted:
2016-09-13
First Post:
2016-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Value of the Follow-up of CALCIneurin Activity to MOdulate Calcineurin Inhibitors-induced Immunosuppression in Lung Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008171', 'term': 'Lung Diseases'}], 'ancestors': [{'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019703', 'term': 'Calcineurin'}], 'ancestors': [{'id': 'D010749', 'term': 'Phosphoprotein Phosphatases'}, {'id': 'D010744', 'term': 'Phosphoric Monoester Hydrolases'}, {'id': 'D004950', 'term': 'Esterases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D047908', 'term': 'Intracellular Signaling Peptides and Proteins'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 134}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-12', 'studyFirstSubmitDate': '2016-09-08', 'studyFirstSubmitQcDate': '2016-09-12', 'lastUpdatePostDateStruct': {'date': '2016-09-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of episodes of acute rejection after LTx', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lung transplantation in end-stage lung diseases'], 'conditions': ['Lung Diseases']}, 'descriptionModule': {'briefSummary': 'The study is an interventional, multicentre, prospective, randomized, controlled, single-blind, comparative trial of two processes for adjusting the inhibitor of calcineurin (CNI) dosage in lung transplant recipients. Recipients will be stratified by transplant center and according to the underlying lung disease (affected with cystic fibrosis or not) and will be randomized to either evaluation of calcineurin activity (CN-a) in combination with CNI blood levels versus CNI blood levels alone in a 1:1 ratio. The objective is to compare the proportion of acute rejection that has required a specific curative treatment at 6 months after transplantation between patients in the two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient placed on the national waiting list for lung transplantation\n* First de novo lung transplantation (single or double LTx)\n* Prevention of allograft rejection by a usual immunosuppressive regimen including CNI (cyclosporine or tacrolimus)\n\nExclusion Criteria:\n\n* Previous lung transplantation or other solid organ transplantation\n* Combined lung transplantation with either liver or renal transplantation'}, 'identificationModule': {'nctId': 'NCT02897895', 'acronym': 'CalciMo-TP', 'briefTitle': 'Study to Evaluate the Value of the Follow-up of CALCIneurin Activity to MOdulate Calcineurin Inhibitors-induced Immunosuppression in Lung Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique Hopitaux De Marseille'}, 'orgStudyIdInfo': {'id': '2014-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'new strategy of immunosuppression monitoring', 'description': 'evaluation of calcineurin activity (CN-a) in combination with CNI blood levels', 'interventionNames': ['Biological: levels of CNI in whole blood', 'Biological: Calcineurin activity (CN-a) in peripheral blood mononuclear cells (PBMCs)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'strategy of reference', 'description': 'CNI (inhibitor of Calcineurin) blood levels alone', 'interventionNames': ['Biological: levels of CNI in whole blood']}], 'interventions': [{'name': 'levels of CNI in whole blood', 'type': 'BIOLOGICAL', 'armGroupLabels': ['new strategy of immunosuppression monitoring', 'strategy of reference']}, {'name': 'Calcineurin activity (CN-a) in peripheral blood mononuclear cells (PBMCs)', 'type': 'BIOLOGICAL', 'armGroupLabels': ['new strategy of immunosuppression monitoring']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13354', 'city': 'Marseille', 'state': 'Marseille', 'country': 'France', 'contacts': [{'name': 'reynaud gaubert martine', 'role': 'CONTACT', 'email': 'martine.reynaud@ap-hm.fr'}, {'name': 'reynaud gaubert martine', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Assistance Publique Hopitaux de Marseille', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}], 'centralContacts': [{'name': 'Martine Reynaud Gaubert, Professor', 'role': 'CONTACT', 'email': 'martine.reynaud@ap-hm.fr'}], 'overallOfficials': [{'name': 'Urielle Desalbres', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistance Publique Hôpitaux de Marseille'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique Hopitaux De Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}