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

a study on Chronic Kidney Disease Kidney Disease Kidney Transplant Transplants

Summary

Eligibility
for people ages 18-70 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
completion around

Description

Summary

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

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

Keywords

Chronic Kidney Disease (CKD), kidney transplant, Kidney Diseases, Chronic Renal Insufficiency, Noninterventional, REGN5459 in study R5459-RT-1944, REGN5458 in study R5459-RT-1944

Eligibility

You can join if…

Open to people ages 18-70

  • 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

You CAN'T join if...

  • There are no exclusion criteria for this study.

Note: Other protocol defined Inclusion/Exclusion criteria may apply

Locations

  • UCSF accepting new patients
    San Francisco California 94143 United States
  • Cedars-Sinai Medical Center accepting new patients
    Los Angeles California 90048 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Regeneron Pharmaceuticals
ID
NCT05106387
Study Type
Observational
Participants
Expecting 12 study participants
Last Updated
Contact us about this trial