Multicenter, Randomized, Open-Label Study to Evaluate AT-1501 in Patients Undergoing Kidney Transplant
A Phase 2, Multicenter, Randomized, Open-Label Study to Evaluate the Safety, Efficacy, and Pharmacodynamics of AT-1501 in Patients Undergoing Kidney Transplant
| Sponsors |
Lead Sponsor: Eledon Pharmaceuticals |
|---|---|
| Source | Eledon Pharmaceuticals |
| Brief 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. |
| Detailed Description | This is a randomized, multicenter, open-label, active control, non-inferiority study to assess the safety and efficacy of AT-1501 compared with tacrolimus. Approximately 120 de novo kidney transplant recipients will receive rabbit anti-thymoglobulin (rATG) (Thymoglobulin®) induction, corticosteroid maintenance, mycophenolate, and will be randomized 1:1. |
||||||||
|---|---|---|---|---|---|---|---|---|---|
| Overall Status | Not yet recruiting | ||||||||
| Start Date | 2021-06-01 | ||||||||
| Completion Date | 2025-03-30 | ||||||||
| Primary Completion Date | 2022-09-30 | ||||||||
| Phase | Phase 2 | ||||||||
| Study Type | Interventional | ||||||||
| Primary Outcome |
|
||||||||
| Secondary Outcome |
|
||||||||
| Enrollment | 120 |
| Condition | |
|---|---|
| Intervention |
Intervention Type: Drug Intervention Name: AT-1501 Description: Patients randomized to treatment arm A will receive induction therapy then AT-1501 and mycophenolate. Arm Group Label: Investigative Arm Intervention Type: Drug Intervention Name: Tacrolimus + mycophenolate Description: Patients randomized to treatment arm B will receive induction therapy then Tacrolimus and mycophenolate. Arm Group Label: Control Arm |
| Eligibility |
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; Gender: All Minimum Age: 18 Years Maximum Age: 99 Years Healthy Volunteers: No |
| Overall Official |
|
||||||
|---|---|---|---|---|---|---|---|
| Overall Contact | Contact information is only displayed when the study is recruiting subjects. |
| Verification Date |
2021-03-01 |
|---|---|
| Responsible Party |
Type: Sponsor |
| Keywords | |
| Has Expanded Access | No |
| Number Of Arms | 2 |
| Arm Group |
Label: Investigative Arm Type: Experimental Description: Arm A: AT-1501 Label: Control Arm Type: Active Comparator Description: Arm B: Tacrolimus |
| Study Design Info |
Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Multicenter Randomized Open-Label Primary Purpose: Treatment Masking: None (Open Label) |
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.