Multicenter, Randomized, Open-Label Study to Evaluate AT-1501 in Patients Undergoing Kidney Transplant

• Status: Not yet recruiting
• Trial end date: 2025-03-30
• Target enrollment: 120
• Participant gender: All

Summary

This is a randomized, multicenter, open-label, active control, non-inferiority study to assess the safety and efficacy of AT-1501 compared with tacrolimus in the incidence of BPAR events through 6 months post-transplant.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eledon Pharmaceuticals
• Treatments: Tacrolimus

Criteria

Inclusion Criteria:

1. Male or female ≥ 18 years of age;

2. Recipient of their first kidney transplant from a living or deceased donor;

3. If eligible for COVID-19 vaccination in their jurisdiction per local guidelines, have received a complete COVID-19 immunization schedule at least 30 days prior to Screening.

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. 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;

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

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

• Donation after Cardiac Death (DCD) criteria; Or

• Kidney Donor Profile Index (KDPI) of >85%; Or

• Is blood group (ABO) incompatible;

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

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

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

9. Current calculated panel reactive antibody (cPRA) > 20%;

10. Current or history of active tuberculosis infection. Laboratory evidence of infection (positive PPD or QuantiFERON-TB Gold) in the absence of clinical infection is exclusionary unless the patient has completed CDC recommended treatment.

a. Patients with documented BCG vaccination and a negative chest x-ray may be included at the Investigator's discretion;

11. Known hypersensitivity to tacrolimus, mycophenolate, rATG, corticosteroids, or any of their components;

12. Recipient is seronegative for EBV at Screening;

13. Positive T- or B-cell crossmatch that is due to HLA antibodies;

14. Presence of a DSA at Screening;

15. Thrombocytopenia (platelets <75,000 per mm3), leukopenia (WBC <3,000 per mm3), or anemia (hemoglobin <8 g/ dL) at Screening;

16. Desensitization therapy within 6 months of transplant;