Summary

Eligibility
for people ages 18-100 (full criteria)
Location
at UCLA
Dates
study started
completion around
Principal Investigator
by Suphamai Bunnapradist, MD, MS (ucla)
Headshot of Suphamai Bunnapradist
Suphamai Bunnapradist

Description

Summary

This study will evaluate the long term safety and efficacy of AT-1501 (tegoprubart) compared with tacrolimus in patients undergoing kidney transplantation.

Official Title

AT-1501-K209: BESTOW-EXTENSION: A Phase 2, Multicenter, Open-Label Extension Study to Evaluate the Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients

Details

This is a multicenter, open-label, active control extension study to assess the long-term safety and efficacy of AT-1501 (tegoprubart) compared with tacrolimus in the preservation of allograft function after kidney transplantation.

The number of patients enrolled for OLE study will depend on the enrollment in the Parent studies. To be eligible for participation in this study, participants must have completed a designated Parent study.

Participants in this study will continue the treatment regimen they were receiving in the Parent study. Dose regimens will include either AT-1501 (tegoprubart) or tacrolimus.

Keywords

Kidney Transplant Rejection, Kidney Transplant, AT-1501, Renal Allograft Rejection, Prophylaxis, CD40L Inhibitor, Humanized blocking antibody to CD40L, monoclonal antibody, renal, transplant, ESRD, tegoprubart, Tacrolimus

Eligibility

Locations

  • University of California Los Angeles
    Los Angeles California 90024 United States
  • Keck School of Medicine of USC
    Los Angeles California 90033 United States

Lead Scientist at University of California Health

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
Eledon Pharmaceuticals
ID
NCT06126380
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 132 study participants
Last Updated