Loyola University Medical Center

Gottlieb Memorial Hospital

MacNeal Hospital

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NCT05983770

Safety and Efficacy of Tegoprubart 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

Summary

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

Eligibility

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

Disease(s) and\or Condition(s)

Kidney Transplant Rejection

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: DRUG
    • Name: AT-1501
    • Description: IV infusions of AT-1501 20 mg/kg over 1 hour.
    • Arm Group Labels: Investigative
    • Type: DRUG
    • Name: Tacrolimus
    • Description: Tacrolimus will be administered BID, targeting a whole blood trough concentration of 6-12 ng/mL until Month 6, and 6-8 ng/mL thereafter.
    • Arm Group Labels: Comparator
Sponsor
  • Eledon Pharmaceuticals