BmemHLA : Origins of the Heterogeneity of the Anti-HLA Memory B Cells in Kidney Transplantation

NCT06956469 | Not Yet Recruiting

• 1 other identifier: CHUBX 2023/39
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Kidney Transplantation; Immunology

Keywords

Kidney; Memory B Cell; Anti-HLA antibodies; Allogeneic events; Transplantation

Outcome Measures

Primary Outcomes (1)

• Memory B cell heterogeneity

  Memory B cell heterogeneity by single cell RNA sequencing

  At inclusion

Secondary Outcomes (1)

• Cytometry

  At inclusion (Day 0), second visit (up to18 months) , third visit (up to 24 months)

Study Arms (5)

Sensitizing events : Pregnancy

ACTIVE COMPARATOR

Patients who have been pregnant

Other: Identification of types of anti-HLA-specific memory LBs

Sensitizing events : Previous transplantation with thrombosis

ACTIVE COMPARATOR

Previous transplantation with early transplantectomy due to thrombosis

Other: Identification of types of anti-HLA-specific memory LBs

Sensitizing events : Previous transplantation with antobody

ACTIVE COMPARATOR

Previous transplantation with antibody-mediated rejection

Other: Identification of types of anti-HLA-specific memory LBs

Whitout any sensitizing event

ACTIVE COMPARATOR

Patients who have anti-HLA antibodies without any sensitizing event identified

Other: Identification of types of anti-HLA-specific memory LBs

Sensitizing events : Transfusion

ACTIVE COMPARATOR

Patients who received a blood transfusion

Other: Identification of types of anti-HLA-specific memory LBs

Interventions

Identification of types of anti-HLA-specific memory LBs OTHER

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.

Sensitizing events : Pregnancy; Sensitizing events : Previous transplantation with antobody; Sensitizing events : Previous transplantation with thrombosis; Sensitizing events : Transfusion; Whitout any sensitizing event

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult kidney transplantation candidate at CHU de Bordeaux
• Sensitized against class I HLA
• Only on type of sensitizing event among : transfusion, pregnancy, previous transplantation, no senitizing event

You may not qualify if:

• Pediatric kidney transplantation candidate at CHU de Bordeaux
• Rituximab injection
• Ongoing treatment with immunosuppressive drugs
• Non-cutaneous carcinoma, chronic viral infection
• Acute infection
• Recent vaccination (\<1 month)

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Central Study Contacts

Claire LEIBLER, MD

CONTACT

05 57 82 21 46; claire.leibler@chu-bordeaux.fr

Jonathan VISENTIN, PharmD, PhD

CONTACT

05 57 82 24; jonathan.visentin@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2025
• First Posted: May 4, 2025
• Study Start: June 15, 2025
• Primary Completion: June 15, 2025
• Study Completion (Estimated): December 15, 2028
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share