Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-03-08 @ 1:40 AM
Study NCT ID:
NCT03798860
Status:
RECRUITING
Last Update Posted:
2024-10-10
First Post:
2018-09-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monitoring of Donor-specific Antibodies After Treatment with Immunoglobulins, Plasmapheresis and Rituximab in Lung Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-08', 'studyFirstSubmitDate': '2018-09-26', 'studyFirstSubmitQcDate': '2019-01-07', 'lastUpdatePostDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Donor-specific Antibodies Clearance', 'timeFrame': '6, 12, 18, 24 months', 'description': 'The DSA clearance is defined as absence of DSA in the Luminex test, which is performed every 6 months after treatment end.'}], 'secondaryOutcomes': [{'measure': 'Graft survival', 'timeFrame': '1, 3, 5 years', 'description': 'Graft survival is defined as freedom from mortality and re-transplantation'}, {'measure': 'Incidence of acute cellular and humoral rejections and chronic lung allograft dysfunction (CLAD)', 'timeFrame': '1, 3, 5 years'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Transplantation', 'Donor-specific Anti-human Leukocyte Antigen(HLA) Antibodies']}, 'descriptionModule': {'briefSummary': 'Single-arm, prospective observational study', 'detailedDescription': 'This is an observational study to monitor the treatment of donor-specific antibodies in lung transplant recipients with detection of donor-specific antibodies. All consented subjects will be approached for participation. The study will evaluate the effectiveness of the treatment protocol of donor-specific antibodies with Immunoglobulins or combined treatment with Immunoglobulins, Plasmapheresis and Rituximab after lung transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients after lung transplantation with detection of donor-specific antibodies', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients after lung transplantation with detection of donor-specific antibodies\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT03798860', 'briefTitle': 'Monitoring of Donor-specific Antibodies After Treatment with Immunoglobulins, Plasmapheresis and Rituximab in Lung Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'Hannover Medical School'}, 'officialTitle': 'Monitoring of Donor-specific Antibodies (DSA) After Combined Treatment with Immunoglobulin a and Immunoglobulin M-enriched Intravenous Human Immunoglobulins and Plasmapheresis and Rituximab in Lung Transplantation', 'orgStudyIdInfo': {'id': 'DSA-2018'}}, 'armsInterventionsModule': {'interventions': [{'name': 'blood samples', 'type': 'DIAGNOSTIC_TEST', 'description': 'For performing the Luminex solid phase assay (SPA) test, 7.5 ml of patient whole blood are collected from a peripheral vein.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hanover', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Susanne Freyt', 'role': 'CONTACT', 'email': 'freyt.susanne@mh-hannover.de', 'phone': '+49 511-532-3450'}, {'name': 'Fabio Ius, Dr.', 'role': 'CONTACT'}], 'facility': 'Hannover Medical School, Department of Cardiothoracic, Transplant and Vascular Surgery', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}], 'centralContacts': [{'name': 'Fabio Ius, Dr.', 'role': 'CONTACT', 'email': 'Ius.Fabio@mh-hannover.de', 'phone': '+49 511-532-2125'}, {'name': 'Susanne Freyt', 'role': 'CONTACT', 'email': 'freyt.susanne@mh-hannover.de', 'phone': '+49 511-532-3450'}], 'overallOfficials': [{'name': 'Fabio Ius, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hannover Medical School'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hannover Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}