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

Inclusion criteria

• Male or female ≥ 18 years of age
• Recipient of their first kidney transplant from a living or deceased donor
• Agree to comply with contraception requirements during and for at least 90 days after the last administration of study drug

Exclusion criteria

• Induction therapy, other than study assigned rATG, planned as part of initial immunosuppressive regimen
• Currently treated with any systemic immunosuppressive regimen, including immunologic biologic therapies, with the exception of 5 mg prednisone or equivalent daily;
• Previous treatment with AT 1501 or any other anti CD40LG therapy
• 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
• Will receive a kidney with an anticipated cold ischemia time of \> 30 hours;
• 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)
• Human leukocyte antigen identical (two haplotype match or zero HLA mismatch) donor
• Medical conditions that require chronic use of systemic steroids at a dose higher than 5 mg prednisone or equivalent per day
• History of a TE event, known hypercoagulable state, or condition requiring long term anticoagulation:
• Positive T- or B-cell crossmatch that is due to HLA antibodies or presence of a DSA at Screening