Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation

Eledon Pharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: Kidney Transplant Rejection

Treatments: Drug: Tacrolimus; Drug: AT-1501

Study type: Interventional

Funder types: Industry

Identifiers

NCT05983770

2023-503336-41-00 (Other Identifier)

AT-1501-K207

U1111-1278-5225 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Investigative

Experimental group

Description:

AT-1501 monoclonal antibody targeting CD40L given as an IV infusion

Treatment:

Drug: AT-1501

Comparator

Active Comparator group

Description:

Tacrolimus administered BID, targeting a whole blood trough concentration of 6-12 ng/mL until Month 6, and 6-8 ng/mL thereafter

Treatment:

Drug: Tacrolimus