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Could a lupus drug unlock kidney transplants for Hard-to-Match patients?

NCT ID NCT07539857

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a short course of belimumab, a drug used for lupus, can improve detection of immune cells that cause transplant rejection. The goal is to help highly sensitized kidney transplant candidates—people whose immune systems are very picky about donor organs—get matched faster. Twenty-five adults will receive belimumab and provide blood samples to see if it changes their immune profile and leads to more donor offers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Belimumab (Benlysta)
What this could lead to
If successful, this could help highly sensitized kidney transplant candidates get donor organs faster and more safely by improving immune matching.
What could go wrong
This is a small, early-phase study with only 25 participants, so results may not apply broadly. Belimumab may not effectively mobilize the targeted cells, and the approach may not improve transplant access.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 25 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Jan 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

To be eligible for participation in this study, a subject must meet all of the following criteria: Adults aged ≥18 and ≤75 years Candidate for kidney transplantation Highly sensitized, as determined by either: * 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 Female subjects are eligible if they meet one of the following criteria: Not pregnant or breastfeeding, as confirmed by a negative pregnancy test at screening Of non-childbearing potential (i.e., status post hysterectomy, postmenopausal, bilateral oophorectomy, documented bilateral tubal ligation, or other permanent sterilization procedure) Of childbearing potential and willing to use effective contraception and agree not to become pregnant during the study A potential subject who meets any of the following criteria will be excluded from participation: Active pregnancy, as confirmed by a positive urine β-hCG test or a positive serum β-hCG test, adjusted for end-stage renal disease (ESRD) Significant hypogammaglobulinemia (IgG \<4.0 g/L) or IgA deficiency (IgA \<0.1 g/L) Receipt of any vaccination within 3 months prior to screening Enrollment in another clinical trial investigating an investigational drug or device at the time of belimumab treatment and delisting; participation in a desensitization trial after assessment of the primary outcome is permitted Previous administration of any of the following agents within 365 days prior to screening: BAFF inhibitors (e.g., belimumab, tabalumab) Monoclonal antibodies targeting CD20 (e.g., rituximab) Monoclonal antibodies targeting CD52 (e.g., alemtuzumab) Lymphocyte-depleting agents (e.g., rATG, ATGAM) IL-6 inhibitors or IL-6/IL-6R modulators (e.g., tocilizumab, clazakizumab) Proteasome inhibitors (e.g., bortezomib) Previous administration of high-dose corticosteroids (\>50 mg prednisolone or equivalent per day) within 90 days prior to screening Active infection at screening, defined as any of the following: Hospitalization for treatment within 30 days prior to screening Current use of parenteral (intravenous or intramuscular) antimicrobial therapy (including antibacterial, antiviral, antifungal, or antiparasitic agents) Current serologic evidence of viral hepatitis, defined as positivity for HBsAg or HBcAb, or a positive hepatitis C antibody test without antiviral treatment Uncontrolled HIV infection, defined as CD4 count \<250 cells/mm³ and/or detectable viremia History of a primary immunodeficiency, including complement deficiencies Neutrophil count \<1.5 × 10⁹/L Current indication for blood product transfusion at screening, or a high likelihood of requiring transfusion during the treatment phase, in the opinion of the investigator Significant history of infections that, in the opinion of the investigator, would make participation unsuitable History of anaphylactic or severe allergic reaction to parenteral administration of human or murine proteins or monoclonal antibodies Active malignancy or a history of malignancy within the past 5 years, except for adequately treated basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix with no evidence of metastatic disease for at least 3 years Evidence of psychiatric illness that, in the opinion of the investigator, would make participation unsuitable Any other abnormal laboratory value or intercurrent medical condition that, in the opinion of the investigator, would make participation unsuitable Known mental incapacity or language barriers precluding adequate understanding of the informed consent process and study procedures

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Leiden University Medical Centre

    Leiden, 2333 ZA, Netherlands

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