Safety, Pharmacokinetics, and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant

Eledon Pharmaceuticals

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Prevention of Rejection in Kidney Transplant

Treatments: Drug: AT-1501

Study type: Interventional

Funder types: Industry

Identifiers

NCT05027906

2021-003830-36 (EudraCT Number)

AT-1501-K102

Details and patient eligibility

About

This study will evaluate the safety, PK, and efficacy of AT 1501 in patients undergoing kidney transplantation.

Full description

This study will evaluate the safety, PK, and efficacy of AT 1501 in patients undergoing kidney transplantation. Up to 48 de novo kidney transplant recipients will receive AT-1501 in combination with rATG induction with corticosteroids (CS), and mycophenolate as maintenance therapy.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Male or female ≥ 18 years of age
2. Recipient of their first kidney transplant from a living or deceased donor
3. Agree to comply with contraception requirements during and for at least 90 days after the last administration of study drug

Exclusion criteria

1. Induction therapy, other than study assigned rATG, planned as part of initial immunosuppressive regimen

2. Currently treated with any systemic immunosuppressive regimen, including immunologic biologic therapies, with the exception of 5 mg prednisone or equivalent daily;

3. Previous treatment with AT 1501 or any other anti CD40LG therapy

4. The patient has previously received a bone marrow transplant or any other solid organ transplant, including a kidney, or will be undergoing a multi organ or dual kidney transplant

5. Will receive a kidney with an anticipated cold ischemia time of > 30 hours;

6. Will receive a kidney from a donor that meets any of the following criteria:

   • Donation after Cardiac Death (DCD) criteria; or
   • Extended Criteria Donor (ECD) criteria, defined as:
   • Is blood group (ABO) incompatible; or
   • Age ≥ 60 years; or Age 50-59 years with any 2 of the following criteria:
   • Death due to cerebrovascular accident
   • History of hypertension
   • Terminal creatinine ≥ 133 μmol/L (1.5 mg/dL)

7. Human leukocyte antigen identical (two haplotype match or zero HLA mismatch) donor

8. Medical conditions that require chronic use of systemic steroids at a dose higher than 5 mg prednisone or equivalent per day

9. History of a TE event, known hypercoagulable state, or condition requiring long term anticoagulation:

10. 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: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

AT-1501 Single Arm

Experimental group

Description:

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

Treatment:

Drug: AT-1501