Chronic Kidney Disease (CKD) Clinical Trial
Official title:
A Noninterventional Extension Study for Patients Treated in Study R5459-RT-1944 With REGN5459 or REGN5458 (BCMA x CD3 Bispecific Antibodies) Who Receive A Kidney Transplant
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
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