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

Eligibility 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
• 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:
• * 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
• 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:
• 1. Patients with a history of clotted venous access not requiring long term anticoagulation may be included at the Investigator's discretion if have no other history of TE events or known hypercoagulable state