An Observational Extension Study for Adult Patients Treated in Study R5459-RT-1944 Who Receive a Kidney Transplant

NCT05106387 · tracked via the Priya Life Science USA tracker

Sponsor

Regeneron Pharmaceuticals

Phase

Observational

Started

2023-10-19

Last updated

2026-07-20

Condition(s) studied

Chronic Kidney Disease (CKD)

Investigational drug(s) / intervention(s)

Noninterventional

Noninterventional: No investigational treatment will be given in this noninterventional extension study

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

Inclusion Criteria: 1. Received at least 1 dose of treatment with vonsetamig in study R5459-RT-1944 \[NCT05092347\]. 2. Received after acceptable crossmatching, a kidney transplant while enrolled in study R5459-RT-1944 3. Willing and able to comply with clinic visits and study-related procedures 4. Provide informed consent signed by study patient or legally acceptable representative Exclusion Criteria: 1.There are no exclusion criteria for this study. Note: Other protocol defined Inclusion/Exclusion criteria may apply

Primary outcome measure(s)

Incidence of Adverse Events — Up to 12 months post-kidney transplant
Incidence of Serious Adverse Events — Up to 12 months post-kidney transplant

Trial sites (9)

Facility	City	Region	Status
Cedars-Sinai Medical Center	Los Angeles	California	Recruiting
University of California Irvine	Orange	California	Recruiting
Connie Frank Transplant Center at UCSF	San Francisco	California	Recruiting
Yale University of Medicine	New Haven	Connecticut	Completed
Comprehensive Transplant Center	Chicago	Illinois	Recruiting
John Hopkins Hospital	Baltimore	Maryland	Recruiting
University of Minnesota	Minneapolis	Minnesota	Recruiting
New York University Langone Health	New York	New York	Completed
Penn Transplant Institute	Philadelphia	Pennsylvania	Recruiting

More Regeneron Pharmaceuticals trials in the USA

A Trial to Find Out if REGN4336 is Safe and How Well it Works Alone and in Combination With REGN5678 for Adult Participants With Advanced Prostate Cancer Recruiting

A Trial to Learn if Odronextamab Combined With Chemotherapy is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Chemotherapy for Adult Participants With Follicular Lymphoma Active, not recruiting

A Study of REGN5093 in Adult Patients With Mesenchymal Epithelial Transition Factor (MET)-Altered Advanced Non-Small Cell Lung Cancer Active, not recruiting

A Proof-of-Concept Study to Learn Whether Linvoseltamab Can Eliminate Abnormal Plasma Cells That May Lead to Multiple Myeloma in Adult Patients With High-Risk Monoclonal Gammopathy of Undetermined Significance or Non-High-Risk Smoldering Multiple Myeloma Recruiting

A Study of Cemiplimab Plus Chemotherapy Versus Cemiplimab Plus Chemotherapy Plus Other Cancer Treatments for Adult Patients With Operable Non-Small Cell Lung Cancer (NSCLC) Active, not recruiting

Other trials for the same condition

The Effect of Retatrutide Once Weekly on Cardiovascular Outcomes and Kidney Outcomes in Adults Living With Obesity (TRIUMPH-Outcomes) Active, not recruiting

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) Active, not recruiting

Official registry record

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 NCT05106387 on ClinicalTrials.gov ↗ ← All trials in the USA