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Purpose

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

Condition

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

ArmDescriptionAssigned Intervention
Experimental
Investigative 		AT-1501 monoclonal antibody targeting CD40L given as an IV infusion
  • Drug: AT-1501
    IV infusions of AT-1501 20 mg/kg over 1 hour.
    Other names:
    • Tegoprubart
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
  • Drug: Tacrolimus
    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.

Recruiting Locations

University of Kansas Medical Center
Kansas City, Kansas 66160

More Details

Status
Recruiting
Sponsor
Eledon Pharmaceuticals

Study Contact

Eledon Pharmaceuticals
949-238-8090
clinicaltrials@eledon.com

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.