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)
NCT ID: NCT05092347
Last Updated: 2025-04-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
56 participants
INTERVENTIONAL
2022-08-02
2026-12-12
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Vonsetamig
Vonsetamig
Administered by intravenous (IV) infusion
Interventions
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Vonsetamig
Administered by intravenous (IV) infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Adequate hematologic and adequate hepatic function as defined in the protocol
3. Willing and able to comply with clinic visits and study-related procedures
Exclusion Criteria
2. Central nervous system (CNS) pathology or history of CNS neurodegenerative or movement disorders
3. Patients who have had their spleen removed, including patients with functional asplenia
4. Patients who have received a stem cell transplantation within 5 years
5. Use of investigational agents within 8 weeks or 5 half-lives of study drug administration (whichever is larger)
6. Total plasma IgG \<300 mg/dL at screening
7. 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
8. Received a calcineurin inhibitor (eg, tacrolimus, cyclosporine) within 30 days of study drug administration
9. 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
10. 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
11. Has received a COVID-19 vaccination, as described in the protocol
18 Years
70 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Connie Frank Transplant Center at UCSF
San Francisco, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California Irvine
Orange, California, United States
Yale University of Medicine
New Haven, Connecticut, United States
Medstar Georgetown Transplant Institute - 2-PHC
Washington D.C., District of Columbia, United States
Comprehensive Transplant Center
Chicago, Illinois, United States
John Hopkins Hospital
Baltimore, Maryland, United States
University of Minnesota
Minneapolis, Minnesota, United States
New York University Langone Health
New York, New York, United States
Penn Transplant Institute
Philadelphia, Pennsylvania, United States
Countries
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Central Contacts
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Other Identifiers
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R5459-RT-1944
Identifier Type: -
Identifier Source: org_study_id
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