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NCT05027906PHASE1, PHASE2Recruiting

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

Eledon Pharmaceuticals

Start Date

2/18/2022

Completion Date

1/1/2027

Summary

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

Detailed 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.

Eligibility Criteria

Age Range: 18 years to 100 years

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

Interventions

DRUG

AT-1501

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Conditions

Prevention of Rejection in Kidney Transplant

Locations

University of Cincinnati

Cincinnati, Ohio 45267

United States

Royal Prince Alfred Hospital

Camperdown, New South Wales 2050

Australia

Royal Adelaide Hospital

Adelaide, South Australia SA 5000

Australia

Fundação Oswaldo Ramos - Hospital do Rim

São Paulo,

Brazil

Providence Health Care - St. Paul's Hospital

Vancouver, British Columbia V6Z 1Y6

Canada

Vancouver General Hospital

Vancouver, British Columbia V6Z 1Y6

Canada

McGill University Health Care Centre

Montreal, Quebec H4A 3J1

Canada

Liverpool University Hospitals NHS Foundation Trust - Royal Liverpool University Hospital

Liverpool, L78XP

United Kingdom

Oxford University Hospitals NHS Foundation Trust - John Radcliffe Hospital

Oxford, OX3 9DU

United Kingdom