Observing kidney transplant outcomes in patients treated with vonsetamig
A Noninterventional Extension Study for Patients Treated in Study R5459-RT-1944 With Vonsetamig (BCMA x CD3 Bispecific Antibody) Who Receive a Kidney Transplant
This study looks at how well kidney transplants work in adults who were treated with vonsetamig before their transplant to see how it affects their health afterward.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Regeneron Pharmaceuticals Industry-sponsored |
| Locations | 9 sites (Los Angeles, California and 8 other locations) |
| Trial ID | NCT05106387 on ClinicalTrials.gov |
What this trial studies
This observational study aims to monitor the long-term outcomes of adult patients who have received a kidney transplant after being treated with vonsetamig in a previous study. Participants will be followed to assess how vonsetamig affects their health post-transplant. The study does not involve administering any new treatments, focusing instead on collecting data regarding patient health and transplant success. It is designed for individuals who have already participated in the earlier study and received a kidney transplant.
Who should consider this trial
Good fit: Ideal candidates are adults who have previously received treatment with vonsetamig and undergone a kidney transplant during the related study.
Not a fit: Patients who have not been treated with vonsetamig or who have not received a kidney transplant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term effects of vonsetamig on kidney transplant recipients.
How similar studies have performed: While this study builds on previous research involving vonsetamig, it is primarily observational and may not have direct precedents in terms of its specific focus on kidney transplant outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Los Angeles, California and 8 other locations
- Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)
- University of California Irvine — Orange, California, United States (Recruiting)
- Connie Frank Transplant Center at UCSF — San Francisco, California, United States (Recruiting)
- Yale University of Medicine — New Haven, Connecticut, United States (Recruiting)
- Comprehensive Transplant Center — Chicago, Illinois, United States (Recruiting)
- John Hopkins Hospital — Baltimore, Maryland, United States (Recruiting)
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
- New York University Langone Health — New York, New York, United States (Recruiting)
- Penn Transplant Institute — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Clinical Trials Administrator
- Email: clinicaltrials@regeneron.com
- Phone: 844-734-6643
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.