drugset / Trial / NCT07539857

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

NCT07539857

Phase 2 Not yet recruiting 25 enrolled Leiden University Medical Center GlaxoSmithKline · collab
NaSingle-groupOpen-labelDiagnostic

Summary

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

Timeline

Start
2026-04-01
Primary completion
2028-01-01
Completion
2030-01-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Belimumab Monoclonal antibody 200 mg Subcutaneous

Indications