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)
← catalyst calendarNCT05092347 · readout in 460 d
Sponsored by Regeneron Pharmaceuticals (industry) · REGN — their whole pipeline →.
Phase
Phase 1/2
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
43actual
Sites
10
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-08-02 | actual | When the study began enrolling |
| Primary completion | 2027-11-22 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-11-22 | estimated | The whole study's end, after follow-up |
| First posted | 2021-10-25 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-06-02 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Chronic Kidney Disease (CKD)
Intervention
- Drug: Vonsetamig — also filed as BCMAxCD3, REGN5459
Primary outcomes
what the primary-completion date above is the date OFIncidence of adverse event(s) of interest (AEI) from the first dose through end of the safety observation period
measured 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
measured Up to 78 weeks
Publications
- PMID 41979896 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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