Overview
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
Eligibility
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:
- There are no exclusion criteria for this study.
Note: Other protocol defined Inclusion/Exclusion criteria may apply