Open
Actively Recruiting
Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation
About
Brief Summary
This study will evaluate the safety and efficacy of AT-1501 compared with tacrolimus in patients undergoing kidney transplantation.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
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
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Study Stats
Protocol No.
23-000895
Category
Genitourinary Disorders
Immune System/Transplant Related Disorders
Principal Investigator
Contact
Location
- UCLA Westwood