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

NCT ID: NCT05106387

Last Updated: 2025-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-19

Study Completion Date

2027-12-24

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Kidney Disease (CKD)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Vonsetamig in study R5459-RT-1944

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

Noninterventional

Intervention Type DRUG

No investigational treatment will be given in this noninterventional extension study

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Noninterventional

No investigational treatment will be given in this noninterventional extension study

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

REGN5459

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status RECRUITING

University of California Irvine

Orange, California, United States

Site Status RECRUITING

Connie Frank Transplant Center at UCSF

San Francisco, California, United States

Site Status RECRUITING

Yale University of Medicine

New Haven, Connecticut, United States

Site Status RECRUITING

Comprehensive Transplant Center

Chicago, Illinois, United States

Site Status RECRUITING

John Hopkins Hospital

Baltimore, Maryland, United States

Site Status RECRUITING

University of Minnesota

Minneapolis, Minnesota, United States

Site Status RECRUITING

New York University Langone Health

New York, New York, United States

Site Status RECRUITING

Penn Transplant Institute

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Clinical Trials Administrator

Role: CONTACT

844-734-6643

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R5459-RT-1956

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Shingrix in Renal Transplant Recipients
NCT04128189 RECRUITING PHASE3