Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2025-12-25 @ 8:42 PM
Study NCT ID:
NCT06956469
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-28
First Post:
2025-04-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
BmemHLA : Origins of the Heterogeneity of the Anti-HLA Memory B Cells in Kidney Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2028-12-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-26', 'studyFirstSubmitDate': '2025-04-25', 'studyFirstSubmitQcDate': '2025-04-25', 'lastUpdatePostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Memory B cell heterogeneity', 'timeFrame': 'At inclusion', 'description': 'Memory B cell heterogeneity by single cell RNA sequencing'}], 'secondaryOutcomes': [{'measure': 'Cytometry', 'timeFrame': 'At inclusion (Day 0), second visit (up to18 months) , third visit (up to 24 months)', 'description': 'Memory B cell heterogeneity by flow cytometry'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Kidney', 'Memory B Cell', 'Anti-HLA antibodies', 'Allogeneic events', 'Transplantation'], 'conditions': ['Kidney Transplantation', 'Immunology']}, 'descriptionModule': {'briefSummary': 'This study will describe the transcriptomic and phenotypic characteristics of anti-HLA memory B cells by comparing five groups of patients awaiting renal transplantation: patients with a single history of pregnancy, transfusion or failure of a first renal transplant requiring transplantectomy within 3 months of transplantation, or after 3 months, and patients without an immunizing allogeneic event. The hypothesis is that these five contexts induce different types of memory B cells with different modalities of reactivation and post-transplant pathogenicity.', 'detailedDescription': 'In kidney transplantation, the production of anti-HLA antibodies directed against the donor (DSA for Donor Specific Antibodies) can be responsible for humoral rejection, the main cause of long-term graft loss. Reactivation of anti-HLA memory B cells after transplantation is thought to play a major role in DSA production and the occurrence of humoral rejection. The investigators hypothesize that the nature and the function of anti-HLA memory B cells could differ depending on how they were initially generated. Several sensitizing events can lead to the production of anti-HLA memory B cells, but differ in terms of their inflammatory environment and the duration of allo-antigen exposure: pregnancy, transfusion or a previous transplantation. For the last group, the investigators want to distinguish two situations: kidney-transplanted patients that had an early transplantectomy due to thrombosis or that had an antibody-mediated rejection. Finally, patients can have anti-HLA antibodies without any sensitizing event identified. The investigators will first use an unbiased approach to test if anti-HLA memory B cells are heterogeneous. The investigators will perform single cell RNA sequencing of sorted anti-HLA B cells, identified with HLA tetramers, of five groups of patients based on their immunization histories. The investigators will further perform a phenotypic characterization of the tetramer+ anti-HLA B cells using spectral cytometry to study their nature and identify novel markers of memory subgroups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult kidney transplantation candidate at CHU de Bordeaux\n* Sensitized against class I HLA\n* Only on type of sensitizing event among : transfusion, pregnancy, previous transplantation, no senitizing event\n\nExclusion Criteria:\n\n* Pediatric kidney transplantation candidate at CHU de Bordeaux\n* Rituximab injection\n* Ongoing treatment with immunosuppressive drugs\n* Non-cutaneous carcinoma, chronic viral infection\n* Acute infection\n* Recent vaccination (\\<1 month)'}, 'identificationModule': {'nctId': 'NCT06956469', 'acronym': 'BmemHLA', 'briefTitle': 'BmemHLA : Origins of the Heterogeneity of the Anti-HLA Memory B Cells in Kidney Transplantation', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Bordeaux'}, 'officialTitle': 'BmemHLA : Origins of the Heterogeneity of the Anti-HLA Memory B Cells in Kidney Transplantation', 'orgStudyIdInfo': {'id': 'CHUBX 2023/39'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sensitizing events : Pregnancy', 'description': 'Patients who have been pregnant', 'interventionNames': ['Other: Identification of types of anti-HLA-specific memory LBs']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sensitizing events : Previous transplantation with thrombosis', 'description': 'Previous transplantation with early transplantectomy due to thrombosis', 'interventionNames': ['Other: Identification of types of anti-HLA-specific memory LBs']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sensitizing events : Previous transplantation with antobody', 'description': 'Previous transplantation with antibody-mediated rejection', 'interventionNames': ['Other: Identification of types of anti-HLA-specific memory LBs']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Whitout any sensitizing event', 'description': 'Patients who have anti-HLA antibodies without any sensitizing event identified', 'interventionNames': ['Other: Identification of types of anti-HLA-specific memory LBs']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Sensitizing events : Transfusion', 'description': 'Patients who received a blood transfusion', 'interventionNames': ['Other: Identification of types of anti-HLA-specific memory LBs']}], 'interventions': [{'name': 'Identification of types of anti-HLA-specific memory LBs', 'type': 'OTHER', 'description': 'Using blood sample, it will be perform single cell RNA sequencing of sorted anti-HLA B cells, identified with HLA tetramers, of five groups of patients based on their immunization histories. It will be further perform a phenotypic characterization of the tetramer+ anti-HLA B cells using spectral cytometry to study their nature and identify novel markers of memory subgroups.', 'armGroupLabels': ['Sensitizing events : Pregnancy', 'Sensitizing events : Previous transplantation with antobody', 'Sensitizing events : Previous transplantation with thrombosis', 'Sensitizing events : Transfusion', 'Whitout any sensitizing event']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Claire LEIBLER, MD', 'role': 'CONTACT', 'email': 'claire.leibler@chu-bordeaux.fr', 'phone': '05 57 82 21 46', 'phoneExt': '+33'}, {'name': 'Jonathan VISENTIN, PharmD, PhD', 'role': 'CONTACT', 'email': 'jonathan.visentin@chu-bordeaux.fr', 'phone': '05 57 82 24', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Bordeaux', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}