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)
Condition(s) studied
Investigational drug(s) / intervention(s)
Vonsetamig: Administered by intravenous (IV) infusion
Study 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.
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
Eligibility
Primary outcome measure(s)
- 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 — Up to 78 weeks
TEAEs include adverse events of special interest (AESI) and serious adverse events (SAEs)
Trial sites (10)
| Facility | City | Region | Status |
|---|---|---|---|
| Cedars-Sinai Medical Center | Los Angeles | California | |
| University of California Irvine | Orange | California | |
| Connie Frank Transplant Center at UCSF | San Francisco | California | |
| Yale University of Medicine | New Haven | Connecticut | |
| Medstar Georgetown Transplant Institute - 2-PHC | Washington D.C. | District of Columbia | |
| Comprehensive Transplant Center | Chicago | Illinois | |
| John Hopkins Hospital | Baltimore | Maryland | |
| University of Minnesota | Minneapolis | Minnesota | |
| New York University Langone Health | New York | New York | |
| Penn Transplant Institute | Philadelphia | Pennsylvania |
More Regeneron Pharmaceuticals trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05092347 on ClinicalTrials.gov ↗ ← All trials in the USA