Kidney TransplantationBmemHLANCT06956469
BmemHLA : Origins of the Heterogeneity of the Anti-HLA Memory B Cells in Kidney Transplantation
A study testing Identification of types of anti-HLA-specific memory LBs in people with Kidney Transplantation and Immunology, run by University Hospital, Bordeaux.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Transplantation, Immunology
- What is being tested?
- Identification of types of anti-HLA-specific memory LBs
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2025to 15 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the detailed description
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.
- Conditions
- Kidney Transplantation, Immunology
- Being tested
- Identification of types of anti-HLA-specific memory LBs
- Keywords
- Kidney, Memory B Cell, Anti-HLA antibodies, Allogeneic events, Transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Identification of types of anti-HLA-specific memory LBsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Sensitizing events : Pregnancy | Active comparator | Patients who have been pregnant Receives: 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 Receives: Other: Identification of types of anti-HLA-specific memory LBs |
| Sensitizing events : Previous transplantation with antobody | Active comparator | Previous transplantation with antibody-mediated rejection Receives: 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 Receives: Other: Identification of types of anti-HLA-specific memory LBs |
| Sensitizing events : Transfusion | Active comparator | Patients who received a blood transfusion Receives: Other: Identification of types of anti-HLA-specific memory LBs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Memory B cell heterogeneity
Memory B cell heterogeneity by single cell RNA sequencing
Measured: At inclusion
Secondary outcomes (1)
Cytometry
Memory B cell heterogeneity by flow cytometry
Measured: At inclusion (Day 0), second visit (up to18 months) , third visit (up to 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2025
- Study start15 Jun 2025 (estimated)
- Primary completion15 Jun 2025 (estimated)
- Study completion15 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06956469
- Sponsor's protocol ID
- CHUBX 2023/39
- Acronym
- BmemHLA
- Status last verified
- May 2025
- First submitted
- 25 Apr 2025
- Last updated
- 28 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BmemHLA : Origins of the Heterogeneity of the Anti-HLA Memory B Cells in Kidney Transplantation
- ClinicalTrials.gov ID
- NCT06956469
- Acronym / sponsor ID
- BmemHLA / CHUBX 2023/39
- Conditions
- Kidney Transplantation, Immunology
- Keywords
- Kidney, Memory B Cell, Anti-HLA antibodies, Allogeneic events, Transplantation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 15 Jun 2025 (estimated)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 15 Dec 2028 (estimated)
- First posted
- 4 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Sensitizing events : Pregnancy | Active comparator | Other: Identification of types of anti-HLA-specific memory LBsPatients who have been pregnant |
| Sensitizing events : Previous transplantation with thrombosis | Active comparator | Other: Identification of types of anti-HLA-specific memory LBsPrevious transplantation with early transplantectomy due to thrombosis |
| Sensitizing events : Previous transplantation with antobody | Active comparator | Other: Identification of types of anti-HLA-specific memory LBsPrevious transplantation with antibody-mediated rejection |
| Whitout any sensitizing event | Active comparator | Other: Identification of types of anti-HLA-specific memory LBsPatients who have anti-HLA antibodies without any sensitizing event identified |
| Sensitizing events : Transfusion | Active comparator | Other: Identification of types of anti-HLA-specific memory LBsPatients who received a blood transfusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Pediatric kidney transplantation candidate at CHU de Bordeaux
- Rituximab injection
- Ongoing treatment with immunosuppressive drugs
- Non-cutaneous carcinoma, chronic viral infection
- Acute infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Identification of types of anti-HLA-specific memory LBsUsing 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. | Other | Sensitizing events : Pregnancy, Sensitizing events : Previous transplantation with antobody, Sensitizing events : Previous transplantation with thrombosis, Sensitizing events : Transfusion, Whitout any sensitizing event |
Primary outcome
Memory B cell heterogeneity
Time frame: At inclusion
Memory B cell heterogeneity by single cell RNA sequencing
1 secondary outcome
Cytometry
Time frame: At inclusion (Day 0), second visit (up to18 months) , third visit (up to 24 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Identification of types of anti-HLA-specific memory LBs in people with Kidney Transplantation and Immunology, run by University Hospital, Bordeaux.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Claire LEIBLER, MD (05 57 82 21 46 ext. +33, claire.leibler@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Memory B cell heterogeneity (time frame: At inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2025; AzTrials last refreshed its copy on 8 Nov 2026.