An Observational Extension Study for Adult Patients Treated in Study R5459-RT-1944 Who Receive a Kidney Transplant
A Noninterventional Extension Study for Patients Treated in Study R5459-RT-1944 With Vonsetamig (BCMA x CD3 Bispecific Antibody) Who Receive a Kidney Transplant
1 other identifier
observational
20
1 country
9
Brief Summary
The main purpose of this study is to continue to see how vonsetamig works in the body and to monitor the outcomes after kidney transplant for participants previously treated in the R5459-RT-1944 study (NCT05092347). No study drug will be given during this study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2023
Longer than P75 for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 22, 2021
CompletedFirst Posted
Study publicly available on registry
November 3, 2021
CompletedStudy Start
First participant enrolled
October 19, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 23, 2028
April 17, 2026
April 1, 2026
2.7 years
October 22, 2021
April 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Incidence of Adverse Events
Up to 12 months post-kidney transplant
Incidence of Serious Adverse Events
Up to 12 months post-kidney transplant
Secondary Outcomes (16)
Incidence of biopsy-proven kidney allograft rejection
Up to 12 Months
Time to diagnosis of biopsy-proven kidney allograft rejection
Up to 12 Months
Responsiveness to therapy by 12 months of biopsy-proven kidney allograft rejection
Up to 12 Months
Incidence of graft loss
Up to 12 Months
Time to graft loss
Up to 12 Months
- +11 more secondary outcomes
Study Arms (1)
Vonsetamig in study R5459-RT-1944
Received a kidney transplant and were administered vonsetamig in study R5459-RT-1944 \[NCT05092347\].
Interventions
No investigational treatment will be given in this noninterventional extension study
Eligibility Criteria
This study is designed to collect safety and outcomes data in patients aged 18 through 70 years who receive a kidney transplant and were administered vosentamig in study R5459-RT-1944 \[NCT05092347\].
You may qualify if:
- Received at least 1 dose of treatment with vonsetamig in study R5459-RT-1944 \[NCT05092347\].
- Received after acceptable crossmatching, a kidney transplant while enrolled in study R5459-RT-1944
- Willing and able to comply with clinic visits and study-related procedures
- Provide informed consent signed by study patient or legally acceptable representative
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trial Management
Regeneron Pharmaceuticals
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2021
First Posted
November 3, 2021
Study Start
October 19, 2023
Primary Completion (Estimated)
June 15, 2026
Study Completion (Estimated)
February 23, 2028
Last Updated
April 17, 2026
Record last verified: 2026-04