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Chronic Kidney Disease (CKD)Phase 1/2NCT05092347

A Study to Learn How Safe and Tolerable Vonsetamig is in Adult Patients With Chronic Kidney Disease (CKD) Who Need Kidney Transplantation and Are Highly Sensitized to Human Leukocyte Antigen (HLA)

A Phase 1/2 study testing Vonsetamig in people with Chronic Kidney Disease (CKD), run by Regeneron Pharmaceuticals at 10 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The purpose of this study is to determine whether vonsetamig will safely decrease anti-HLA antibodies to allow for kidney transplantation. Vonsetamig is being studied for treatment of patients in need of kidney transplantation who are highly sensitized to HLA. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Chronic Kidney Disease (CKD)
What is being tested?
Vonsetamig
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
10 sitesUnited States
Study dates
2 Aug 2022to 22 Nov 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has Chronic Kidney Disease (CKD) requiring hemodialysis, and awaiting kidney transplant on the United Network for Organ Sharing (UNOS), with a cPRA ≥99.9%, or those with a cPRA >98% (98.1% to 99.8%) who have spent 5 years or longer on the waitlist, as defined in the protocol
  • Adequate hematologic and adequate hepatic function as defined in the protocol
  • Willing and able to comply with clinic visits and study-related procedures

Who cannot join

  • Current or active malignancy not in remission for at least 1 year
  • Central nervous system (CNS) pathology or history of CNS neurodegenerative or movement disorders
  • Patients who have had their spleen removed, including patients with functional asplenia
  • Patients who have received a stem cell transplantation within 5 years
  • Use of investigational agents within 8 weeks or 5 half-lives of study drug administration (whichever is larger)
  • Total plasma IgG <300 mg/dL at screening
Show all 12Show fewer
  • Continuous systemic corticosteroid treatment with more than 10 mg per day of prednisone (or anti-inflammatory equivalent) within 72 hours of start of study drug administration
  • Received a calcineurin inhibitor (eg, tacrolimus, cyclosporine) within 30 days of study drug administration
  • Received cyclophosphamide, rituximab, obinutuzumab, other anti-CD20 or B cell-depleting agents, or proteasome inhibitors or anti-CD38 therapies (eg, isatuximab, daratumumab) within 12 months of study drug administration
  • Prior treatment with any anti-BCMA antibody (including antibody drug conjugate or bsAb) or BCMA-directed CAR-T cell therapy, as described in the protocol
  • Has received a COVID-19 vaccination, as described in the protocol
  • Note: Other protocol defined inclusion / exclusion criteria apply

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • John Hopkins Hospital

    Baltimore, Maryland, 21224

  • Comprehensive Transplant Center

    Chicago, Illinois, 60611

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Yale University of Medicine

    New Haven, Connecticut, 06520

  • New York University Langone Health

    New York, New York, 10016

  • University of California Irvine

    Orange, California, 92868

  • Penn Transplant Institute

    Philadelphia, Pennsylvania, 19104

  • Connie Frank Transplant Center at UCSF

    San Francisco, California, 94143

  • Medstar Georgetown Transplant Institute - 2-PHC

    Washington D.C., District of Columbia, 20007

Other trials in United States

About this study

Official title: A Dose Escalation and Proof-of-Concept Study of Vonsetamig (BCMA × CD3 Bispecific Antibody) for Desensitization of Chronic Kidney Disease Patients in Need of Kidney Transplantation Who Are Highly Sensitized to Human Leukocyte Antigen

The purpose of this study is to determine whether vonsetamig will safely decrease anti-HLA antibodies to allow for kidney transplantation.

Vonsetamig is being studied for treatment of patients in need of kidney transplantation who are highly sensitized to HLA.

The study is looking at several other research questions, including:

  • Side effects that may be experienced from taking vonsetamig
  • How vonsetamig works in the body
  • How much vonsetamig is present in the blood
  • If vonsetamig works to lower levels of antibodies to HLA
Being tested
Vonsetamig
Keywords
Kidney Transplant, Hemodialysis, Desensitization, Human Leukocyte Antigen (HLA)
Medical subject headings
Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VonsetamigDrug

    Also called BCMAxCD3, REGN5459

    Administered by intravenous (IV) infusion

Study groups in NCT05092347
Study groupRoleWhat they receive
VonsetamigExperimentalNot described
Receives: Drug: Vonsetamig

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse event(s) of interest (AEI) from the first dose through end of the safety observation period

    Measured: Up to approximately 6 weeks

  2. Incidence and severity of treatment-emergent adverse events (TEAE)s from the first study drug dose up to the end of the study

    TEAEs include adverse events of special interest (AESI) and serious adverse events (SAEs)

    Measured: Up to 78 weeks

Secondary outcomes (16)

  1. Proportion of Participants with a clinically meaningful reduction in anti-HLA alloantibodies

    Clinically meaningful reduction in anti-HLA alloantibodies are defined as either:

    • Reduction in Calculated panel-reactive antibody (cPRA) from baseline, or
    • Reduction in the peak (immunodominant) anti-HLA mean fluorescence intensity (MFI) to <5,000, or by ≥50% by Single antigen bead (SAB) assay

    Measured: Up to 78 weeks

  2. Maximum reduction in the peak (immunodominant) MFI of anti-HLA alloantibodies from baseline

    Measured: Up to 78 weeks

  3. Percent change from baseline in the peak (immunodominant) MFI

    Measured: Up to 78 weeks

  4. Percent change from baseline in the sum of MFI of anti-HLA alloantibodies using the SAB assay

    Measured: Up to 78 weeks

  5. Time to first clinically meaningful reduction in anti-HLA alloantibody levels by SAB assay

    Defined as peak anti-HLA alloantibody MFI <5,000 or ≥50% reduction

    Measured: Up to 78 weeks

  6. Time to maximal reduction in anti-HLA alloantibody levels by SAB assay

    Defined as peak anti-HLA alloantibody MFI <5,000 or ≥50% reduction

    Measured: Up to 78 weeks

  7. Maximum reduction in cPRA from baseline

    Measured: Up to 78 weeks

  8. Time to first clinically meaningful reduction in cPRA

    Measured: Up to 78 weeks

  9. Time to maximal reduction in cPRA from baseline

    Measured: Up to 78 weeks

  10. Duration of a reduction in peak anti-HLA alloantibody to MFI <5,000 or by ≥50% by SAB assay

    Measured: Up to 78 weeks

  11. Duration of maximal reduction in anti-HLA alloantibody MFI by SAB assay

    Measured: Up to 78 weeks

  12. Duration of maximal reduction in cPRA by SAB assay

    Measured: Up to 78 weeks

  13. Serum concentration of Immunoglobulin (Ig) classes over time

    Measured: Up to 78 weeks

  14. Percent change from baseline of serum concentration of Ig classes

    Measured: Up to 78 weeks

  15. Concentration of vonsetamig in serum over time

    Measured: Up to 78 weeks

  16. Incidence of treatment-emergent anti-drug antibodies (ADAs) to vonsetamig over time

    Measured: Up to 78 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Oct 2021
  2. Study start2 Aug 2022
  3. Primary completion22 Nov 2027 (estimated)
  4. Study completion22 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05092347
Sponsor's protocol ID
R5459-RT-1944
Status last verified
May 2026
First submitted
22 Oct 2021
Last updated
2 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Publications

  • Karam S, Boudhabhay I, Jhaveri KD. Bispecific Antibodies for Glomerular Diseases: Are We Ready for Prime Time? J Am Soc Nephrol. 2026 Apr 14. doi: 10.1681/ASN.0000001120. Online ahead of print. No abstract available.

    PubMed 41979896

  • Chandran S, Vincenti F. Antiplasma cell antibodies: A new era of human leukocyte antigen antibody control in solid organ transplantation. Am J Transplant. 2025 Jan;25(1):19-26. doi: 10.1016/j.ajt.2024.10.005. Epub 2024 Oct 9.

    PubMed 39384021

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Vonsetamig in people with Chronic Kidney Disease (CKD), run by Regeneron Pharmaceuticals at 10 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse event(s) of interest (AEI) from the first dose through end of the safety observation period (time frame: Up to approximately 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05092347, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.

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