| Trial ID: | L0381 |
| Source ID: | NCT05092347
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| Associated Drug: |
Vonsetamig
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| Title: |
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)
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| Acronym: |
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| Status: |
RECRUITING
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| Study Results: |
NO
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| Results: |
|
| Conditions: |
Chronic Kidney Disease (CKD)
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| Interventions: |
DRUG: Vonsetamig
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| Outcome Measures: |
Primary: Incidence of adverse event(s) of interest (AEI) from the first dose through end of the safety observation period, Up to approximately 6 weeks|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), Up to 78 weeks | Secondary: 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, Up to 78 weeks|Maximum reduction in the peak (immunodominant) MFI of anti-HLA alloantibodies from baseline, Up to 78 weeks|Percent change from baseline in the peak (immunodominant) MFI, Up to 78 weeks|Percent change from baseline in the sum of MFI of anti-HLA alloantibodies using the SAB assay, Up to 78 weeks|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, Up to 78 weeks|Time to maximal reduction in anti-HLA alloantibody levels by SAB assay, Defined as peak anti-HLA alloantibody MFI \<5,000 or ≥50% reduction, Up to 78 weeks|Maximum reduction in cPRA from baseline, Up to 78 weeks|Time to first clinically meaningful reduction in cPRA, Up to 78 weeks|Time to maximal reduction in cPRA from baseline, Up to 78 weeks|Duration of a reduction in peak anti-HLA alloantibody to MFI <5,000 or by ≥50% by SAB assay, Up to 78 weeks|Duration of maximal reduction in anti-HLA alloantibody MFI by SAB assay, Up to 78 weeks|Duration of maximal reduction in cPRA by SAB assay, Up to 78 weeks|Serum concentration of Immunoglobulin (Ig) classes over time, Up to 78 weeks|Percent change from baseline of serum concentration of Ig classes, Up to 78 weeks|Concentration of vonsetamig in serum over time, Up to 78 weeks|Incidence of treatment-emergent anti-drug antibodies (ADAs) to vonsetamig over time, Up to 78 weeks
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| Sponsor/Collaborators: |
Sponsor: Regeneron Pharmaceuticals
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE1|PHASE2
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| Enrollment: |
56
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: NA|Intervention Model: SEQUENTIAL|Masking: NONE|Primary Purpose: TREATMENT
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| Start Date: |
2022-08-02
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| Completion Date: |
2026-12-12
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| Results First Posted: |
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| Last Update Posted: |
2025-03-14
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| Locations: |
Cedars-Sinai Medical Center, Los Angeles, California, 90048, United States|University of California Irvine, Orange, California, 92868, United States|Connie Frank Transplant Center at UCSF, San Francisco, California, 94143, United States|Yale University of Medicine, New Haven, Connecticut, 06520, United States|Comprehensive Transplant Center, Chicago, Illinois, 60611, United States|John Hopkins Hospital, Baltimore, Maryland, 21224, United States|University of Minnesota, Minneapolis, Minnesota, 55455, United States|New York University Langone Health, New York, New York, 10016, United States|Penn Transplant Institute, Philadelphia, Pennsylvania, 19104, United States
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| URL: |
https://clinicaltrials.gov/show/NCT05092347
|
