Recruiting

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

Sponsor:

Regeneron Pharmaceuticals

Code:

NCT05106387

Conditions

Chronic Kidney Disease (CKD)

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

Noninterventional

Study Details

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.

Conditions

Chronic Kidney Disease (CKD)

Study ID

NCT05106387

Start date

Oct 19, 2023

Status verified date

Jul, 2026

Completion date

Feb 23, 2028

Anticipated

Primary completion date

Jun 14, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

20 participants

Anticipated

Interventions and Outcome Measures

Arms

Vonsetamig in study R5459-RT-1944

Received a kidney transplant and were administered vonsetamig in study R5459-RT-1944 \[NCT05092347\].

Interventions

Noninterventional

No investigational treatment will be given in this noninterventional extension study

Primary outcome measure

Incidence of Adverse Events [ Time Frame: Up to 12 months post-kidney transplant ]
Incidence of Serious Adverse Events [ Time Frame: Up to 12 months post-kidney transplant ]

Central Contacts and Locations

Central contacts

Clinical Trials Administrator

844-734-6643 clinicaltrials@regeneron.com

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

University of California Irvine

Recruiting

Orange, California, United States, 92868

Connie Frank Transplant Center at UCSF

Recruiting

San Francisco, California, United States, 94143

Comprehensive Transplant Center

Recruiting

Chicago, Illinois, United States, 60611

John Hopkins Hospital

Recruiting

Baltimore, Maryland, United States, 21224

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Penn Transplant Institute

Recruiting

Philadelphia, Pennsylvania, United States, 19104

More Information

Sponsor

Regeneron Pharmaceuticals

Last update posted

Jul 20, 2026

Last verified

Jul, 2026

Keywords

Kidney Transplant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Regeneron Pharmaceuticals on 2026-07-20.