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

Launched by REGENERON PHARMACEUTICALS · Oct 22, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the health and safety of adult patients who have received a kidney transplant after being treated with a medication called REGN5459 or REGN5458. Researchers want to understand any side effects or serious health issues these patients may experience after their transplant. They are also looking at how well the transplanted kidney is working, whether the body is accepting the new kidney, and how the immune system reacts to it.

To participate, individuals must have received at least one dose of REGN5459 or REGN5458 and either have already had a kidney transplant or be scheduled for one while enrolled in the earlier study. There are no specific exclusions for this trial, meaning most adults who meet the treatment criteria can join. Participants should expect regular clinic visits to monitor their health and provide feedback about their experiences. This study aims to gather important information to help improve care for kidney transplant patients in the future.

Gender

ALL

Eligibility 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