An Observational Extension Study for Adult Patients Treated in Study R5459-RT-1944 Who Receive A Kidney Transplant
About the study
The primary objective of the study is to assess adverse events (AEs) and serious adverse events (SAEs) in kidney transplant recipients previously treated with REGN5459 or REGN5458 in the R5459-RT-1944 study.
The secondary objectives of the study are to evaluate each of the following in kidney transplant recipients previously treated with REGN5459 or REGN5458:
Rates and classification of antibody-mediated and T-cell-mediated kidney allograft rejection
Graft survival
Allograft function
Delayed allograft function
Anti-human leukocyte antigen (HLA) alloantibody levels and calculated panel-reactive antibody (cPRA)
Emergence of de novo donor-specific antibodies
Circulating immunoglobulin (Ig) classes (isotypes)
Pharmacokinetics (PK) of REGN5459 or REGN5458
Who can take part
You may be eligible to participate in the study if you meet the following criteria:
INCLUSION CRITERIA
Inclusion Criteria:
- Received at least 1 dose of treatment with REGN5459 or REGN5458 in study R5459-RT-1944
- Received, or scheduled to receive after acceptable crossmatching, a kidney transplant while enrolled in study R5459-RT-1944
- Willing and able to comply with clinic visits and study-related procedures
- Provide informed consent signed by study patient or legally acceptable representative
EXCLUSION CRITERIA
Exclusion Criteria:
There are no exclusion criteria for this study.
Note: Other protocol defined Inclusion/Exclusion criteria may apply
Study Locations
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How to Apply
Contact the study center to learn if this study is a good match for you.
Study’s details
Contition
Chronic Kidney Disease (CKD)
Age (in years)
18 - 70
Participants needed
12
Est. Completion Date
May 21, 2026
Treatment type
Observational
Sponsor
Regeneron Pharmaceuticals
ClinicalTrials.gov identifier
NCT05106387
Study number
R5459-RT-1956
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