Memory B cells and anti-HLA sensitization in kidney transplant candidates

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.