Memory B cells and anti-HLA sensitization in kidney transplant candidates
Alloreactive Memory B Lymphocytes and Anti-HLA Sensitization in Kidney Transplantation
This project will test whether analyzing memory B cells in adults with anti-HLA antibodies who are waiting for a kidney transplant can help predict their risk of antibody-related rejection.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 51 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Rouen Academic / other |
| Drugs / interventions | rituximab |
| Locations | 1 site (Rouen) |
| Trial ID | NCT07011238 on ClinicalTrials.gov |
What this trial studies
This observational project will characterize the phenotypic, functional and clonal diversity of pre-existing alloreactive memory B lymphocytes in kidney transplant candidates with anti-HLA antibodies. Adult patients on the Rouen University Hospital transplant waiting list will be stratified by incompatible graft rate (IGR) into hyperimmunized (IGR ≥85%), immunized (IGR 50–85%) and naïve (IGR <50%) groups. Blood samples will be analyzed to define Bmem clonality, surface markers and antibody specificities to try to distinguish potentially pathogenic from non-pathogenic responses. Comparing these groups aims to link intensity of prior HLA exposure to features of the alloreactive B cell repertoire that could inform post-transplant humoral risk.
Who should consider this trial
Good fit: Adults (≥18) followed at Rouen University Hospital on the national kidney transplant waiting list who have detectable anti-HLA antibodies and meet one of the defined IGR categories are the intended participants.
Not a fit: Patients without detectable anti-HLA antibodies, those whose sensitization is only from transfusions, people who recently received B-cell–depleting therapy (e.g., rituximab), and individuals not followed at Rouen University Hospital are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this work could help clinicians better predict which sensitized patients face higher risk of antibody-mediated rejection and tailor prevention and monitoring strategies.
How similar studies have performed: Prior studies have identified alloreactive memory B cells in sensitized patients, but using those findings to reliably predict clinical transplant risk is still novel and not yet proven.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Rouen University Hospital patient monitored in the Nephrology and Kidney Transplantation Department, registered on the national kidney transplant waiting list * Carrier of HLA antibodies, including at least anti-HLA2, identified during the last screening * Notion of classic immune-promoting events including at least one previous transplant or pregnancy, or absence of a known immune-promoting event (naïve patient group) * Incompatible graft rate (IGR) * IGR ≥ 85% (hyperimmunized patient group with anti-HLA polyreactivity) or * IGR between 50% and 85% (immunized patient group with a more restricted repertoire of HLA reactivities) or * IGR \< 50% (naïve patient group with no known history of immune-promoting events) * Person who has read and understood the information letter and does not object Not participating in the study * Affiliation to a social security scheme Exclusion Criteria: * Patients who have received rituximab in the previous year (B-cell depleting therapy) * Patients undergoing an HLA desensitization protocol using plasmapheresis and/or rituximab * Patients with an active infection * Persons deprived of their liberty by an administrative or judicial decision or persons placed under judicial protection/guardianship or curatorship
Where this trial is running
Rouen
- University Hopsital of Rouen — Rouen, France (Recruiting)
Study contacts
- Study coordinator: David DM MALLET, Director
- Email: David.Mallet@chu-rouen.fr
- Phone: 02 32 88 82 65
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.