Status:
COMPLETED
Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation
Lead Sponsor:
Eledon Pharmaceuticals
Conditions:
Kidney Transplant Rejection
Eligibility:
All Genders
18-100 years
Phase:
PHASE2
Brief Summary
This study will evaluate the safety and efficacy of AT-1501 compared with tacrolimus in patients undergoing kidney transplantation.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2025
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT05983770
Start Date
August 30 2023
End Date
September 25 2025
Last Update
October 29 2025
Active Locations (43)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California Los Angeles
Los Angeles, California, United States, 90024
2
Keck School of Medicine of USC
Los Angeles, California, United States, 90033
3
University of California, Irvine Medical Center
Orange, California, United States, 92868
4
University of California, Davis Medical Center
Sacramento, California, United States, 95817