Actively Recruiting
Alloreactive Memory B Lymphocytes and Anti-HLA Sensitization in Kidney Transplantation
Led by University Hospital, Rouen · Updated on 2025-06-08
51
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how alloreactive memory B lymphocytes (Bmem) affect kidney transplant rejection in patients sensitized to HLA antigens. This observational study focuses on understanding the diversity and behavior of these B cells in patients awaiting kidney transplantation, especially those with different levels of immune sensitization. The goal is to improve assessment of immunological risk and develop better prevention strategies for humoral rejection by identifying key markers of harmful immune responses. Participants include three groups of patients monitored at Rouen University Hospital: those highly sensitized with broad HLA antibody repertoires, those moderately sensitized with more limited antibody profiles, and controls with no known immunizing events. At enrollment, a single 50 ml blood sample will be collected to analyze the B cells' clonality, phenotype, and gene expression using advanced RNA sequencing techniques targeting specific HLA alleles. During the study, researchers will measure the heterogeneity of alloreactive Bmem and assess their phenotypic, transcriptional, and clonal characteristics. The study aims to provide foundational knowledge about Bmem biology and identify markers that could help predict transplant rejection risk. All data collection occurs at the enrollment visit, with no further interventions, and participation involves routine blood sampling and analysis under medical supervision.
CONDITIONS
Brief Title
Alloreactive Memory B Lymphocytes and Anti-HLA Sensitization
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Patient monitored at Rouen University Hospital in the Nephrology and Kidney Transplantation Department
- Registered on the national kidney transplant waiting list
- Carry HLA antibodies including at least anti-HLA2 identified in the last screening
- Have a history of at least one transplant or pregnancy, or no known immune-promoting events (naïve group)
- Incompatible graft rate (IGR) of at least 85%, or between 50% and 85%, or below 50% depending on patient group
- Has read and understood the information letter and does not object to participation
- Affiliated with a social security scheme
You will not qualify if you...
- Received rituximab treatment within the previous year
- Undergoing HLA desensitization protocol using plasmapheresis and/or rituximab
- Have an active infection
- Are deprived of liberty by administrative or judicial decision or under judicial protection, guardianship, or curatorship
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
At enrollment, participants provide a blood sample to analyze alloreactive memory B lymphocytes targeting HLA alloantigens, including clonality, phenotype, and transcriptome.
1 enrollment visit (in-person)
Duration - Up to 3 years
Participants are observed over time to acquire preliminary data on alloreactive B cell responses prior to and after kidney transplantation.
Follow-up visits as part of routine care
Trial Site Locations
Total: 1 location
1
University Hopsital of Rouen
Rouen, France, 76031
Actively Recruiting
Research Team
D
David DM MALLET, Director
S
Sophie SC CANDON, Professor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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