A Phase 1b, Multicenter, Open Label Study to Evaluate the Safety, Pharmacokinetics and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant
Eledon Pharmaceuticals
Summary
This study will evaluate the safety, PK, and efficacy of AT 1501 in patients undergoing kidney transplantation.
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
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugAT-1501
Investigative Arm
Locations (9)
- University of CincinnatiCincinnati, Ohio
- Royal Prince Alfred HospitalCamperdown, New South Wales
- Royal Adelaide HospitalAdelaide, South Australia
- Fundação Oswaldo Ramos - Hospital do RimSão Paulo
- Providence Health Care - St. Paul's HospitalVancouver, British Columbia
- Vancouver General HospitalVancouver, British Columbia