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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 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2026-04-20

No results posted yet for this study

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

Conditions

  • Kidney Transplant Rejection

Interventions

DRUG

Belimumab Prefilled Syringe [Benlysta]

Monoclonal antibody binding BAFF

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • Leiden University Medical Center

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07539857 on ClinicalTrials.gov