Belimumab to Mobilise Memory B-cells From Secondary Lymhoid Organs to Improve Memory B-cell HLA-specificity Profiling to Support Delisting for Transplant Access in Highly-sensitized

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorLeiden University Medical Center

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Belimumab Prefilled Syringe [Benlysta]

Treatment groups

25 Participants
are divided into 1 treatment group

Sponsors and collaborators