Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation
Purpose
This study will evaluate the safety and efficacy of AT-1501 compared with tacrolimus in patients undergoing kidney transplantation.
Condition
- Kidney Transplant Rejection
Eligibility
- Eligible Ages
- Between 18 Years and 100 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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 Criteria
- 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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Investigative |
AT-1501 monoclonal antibody targeting CD40L given as an IV infusion |
|
|
Active Comparator Comparator |
Tacrolimus administered BID, targeting a whole blood trough concentration of 6-12 ng/mL until Month 6, and 6-8 ng/mL thereafter |
|
Recruiting Locations
Medstar Georgetown University Hospital
Washington, District of Columbia 20007
Washington, District of Columbia 20007
More Details
- Status
- Recruiting
- Sponsor
- Eledon Pharmaceuticals
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 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.