The goal of this clinical trial is to determine whether belimumab can improve detection of circulating HLA-specific memory B cells to support safer and more effective donor organ allocation in highly sensitized kidney transplant candidates.
The main questions it aims to answer are:
Does treatment with belimumab change the antigen specificity profile of circulating HLA-specific memory B cells compared to pre-treatment measurements?
Does a delisting strategy that incorporates mobilized memory B cells improve the probability of donor organ allocation and reduce time to transplantation?
Participants will:
Receive a short course of belimumab treatment
Provide blood samples before and during treatment to assess memory B-cell profiles
Undergo evaluation for potential adjustment of unacceptable HLA specificities (delisting) based on test results
Be followed for donor organ allocation and transplantation outcomes
2% probability of being matched with a donor organ within the Eurotransplant Kidney Allocation System (ETKAS), or
0.5% probability of being matched with a donor organ within the Eurotransplant Acceptable Mismatch (AM) program, if eligible for inclusion in this program Provision of written informed consent for participation in this study Willingness and ability to comply with the study protocol
None
Single group
Belimumab Prefilled Syringe [Benlysta]
DrugMonoclonal antibody binding BAFF
Allocation probability
Number of potential donors in Eurotransplant region based on HLA and ABO compatibility
Belimumab-enhanced HLA-specific memory B-cell profiling
Concordance between HLA antibodies found in the serum and the supernatant of cultured peripheral blood mononuclear cells after belimumab administration.
Antibody-mediated rejection rate at 1 year
To investiage the antibody-mediated rejection rate in kidney transplant recipients of a delisted donor-specific anti-HLA antibody
High-sensitivity flow cytometry B-cell phenotyping
Investigate the impact of belimumab-mediated BAFF inhibition on circulating B-cell phenotype. Peripheral blood mononuclear cells will be phenotyped at day 0, day 28, and day 112. B-cell subsets are classified with the following surface markers: CD19, CD27, CD38, CD24, CD5, immunoglobulins.
Graft failure
To investigate the occurence of graft failure in the 2 years following transplantation. Graft failure is defined as a return to dialysis.
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Leiden University Medical Center
Lead sponsor
GlaxoSmithKline
Collaborator
