This study is in progress, not accepting new patients

Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation

a study on Kidney Transplant Transplants

Summary

Eligibility
for people ages 18-100 (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
completion around

Description

Summary

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

Official Title

AT-1501-K207: BESTOW: a Phase 2, Multicenter, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation

Details

This study is a randomized, multicenter, open-label, active control study to evaluate the safety and efficacy of AT-1501 compared with tacrolimus in the prevention of rejection in patients undergoing kidney transplantation. Up to 120 de novo kidney transplant recipients will receive rATG induction with corticosteroids (CS), and mycophenolate as maintenance therapy, and will be randomized 1:1 to receive either AT-1501 or tacrolimus.

Keywords

Kidney Transplant Rejection, AT-1501, Kidney Transplant, Renal Allograft Rejection, Prophylaxis, CD40L Inhibitor, Humanized blocking antibody to CD40L, Monoclonal Antibody, Renal, Transplant, ESRD, Tegoprubart, Tacrolimus, Investigative

Eligibility

You can join if…

Open to people ages 18-100

  • Male or female ≥ 18 years of age
  • Recipient of their first kidney transplant from a living or deceased donor
  • Agree to comply with contraception requirements during and for at least 90 days after the last administration of study drug

You CAN'T join if...

  • Induction therapy, other than study assigned rATG, planned as part of initial immunosuppressive regimen
  • Currently treated with any systemic immunosuppressive regimen, including immunologic biologic therapies
  • Currently treated with corticosteroids other than topical or inhaled corticosteroids
  • Will receive a kidney with an anticipated cold ischemia time of > 30 hours
  • Will receive a kidney from a donor that meets any of the following:
    • 5a. Donation after Cardiac Death (DCD) criteria; Or
    • 5b. Kidney Donor Profile Index (KDPI) of > 85%; Or
    • 5c. Is blood group (ABO) incompatible
  • Medical conditions that require chronic use of systemic corticosteroids or other immunosuppressants
  • History of a thromboembolic event, known hypercoagulable state, or condition requiring long term anticoagulation
  • Positive T- or B-cell crossmatch that is due to HLA antibodies or presence of a DSA at Screening

Locations

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

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eledon Pharmaceuticals
ID
NCT05983770
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 120 study participants
Last Updated