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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
Treatment
Study Type
Interventional
Phase
Phase 2

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
100 Years

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
Contact
NAKUL DATTA
Location
  • UCLA Westwood
For Providers
NCT No.
NCT05983770
For detailed technical eligibility, visit ClinicalTrials.gov.