Belimumab Phase 2 Study for Highly Sensitized Transplant Candidates
ClinicalTrials.gov Studies
Summary
The NIH ClinicalTrials.gov registry has published a Phase 2 clinical study (NCT07539857) evaluating belimumab (Benlysta) in highly sensitized kidney transplant candidates. The trial aims to determine whether belimumab improves detection of circulating HLA-specific memory B cells to support safer donor organ allocation. Participants will receive belimumab treatment and undergo memory B-cell profiling to evaluate potential adjustment of unacceptable HLA specificities.
What changed
A new Phase 2 clinical trial (NCT07539857) has been registered on ClinicalTrials.gov for belimumab in highly sensitized kidney transplant candidates. The study will enroll participants receiving belimumab via prefilled syringe and collect blood samples before and during treatment to assess memory B-cell profiles. Results will be used to evaluate potential adjustment of unacceptable HLA specificities for donor organ allocation purposes.
This registry entry is informational and does not impose compliance obligations on manufacturers, healthcare providers, or patients. It represents a standard clinical trial registration in the NIH database with no regulatory enforcement implications.
Archived snapshot
Apr 21, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
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
Phase 2 NCT07539857 Kind: PHASE2 Apr 20, 2026
Abstract
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: Belimumab Prefilled Syringe [Benlysta]
Related changes
Get daily alerts for ClinicalTrials.gov Studies
Daily digest delivered to your inbox.
Free. Unsubscribe anytime.
Source
About this page
Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission
Source document text, dates, docket IDs, and authority are extracted directly from NIH.
The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.
Classification
Who this affects
Taxonomy
Browse Categories
Get alerts for this source
We'll email you when ClinicalTrials.gov Studies publishes new changes.
Subscribed!
Optional. Filters your digest to exactly the updates that matter to you.