Clinical Trials

Inclusion Criteria:

• Subject male or female, 18 years or older
• Subject with dialysis dependent renal failure (initiated more than 2 months prior to transplant)
• Subject is to receive a first kidney transplant from a SCD or ECD deceased donor with a DGF risk score using the Irish scale of ≥ 25% (to be determined prior to surgery and before randomization)
• Subject able to provide written informed consent
• Subject must be willing and able to comply with the requirements of the study protocol
• Female subjects of child-bearing potential must have a negative serum pregnancy test (serum beta-hCG) and must be practicing an effective, reliable, and medically approved contraceptive regimen at the time of consent and for up to 5 months following discontinuation of treatment

Exclusion Criteria:

• Subject to receive a multi-organ transplant
• Subject to receive kidney(s) from donors < 6 years of age
• Subject to receive a dual kidney transplant (from same donor, including en bloc)
• Subject to receive a living donor kidney
• Subject is highly sensitized (high risk to develop acute AMR) to the donor (as determined by local center practice). Testing to determine high risk may include but is not limited to Flow cytometric cross match, single antigen bead testing and/or complement dependent cytotoxicity
• Subject has received a previous transplant
• Subject is participating in another investigational study
• Subject has a body mass index (BMI) >40 kg/m2 at screening
• Subject will be the recipient of an A, B, O Blood Glycoproteins (ABO)(blood type) incompatible kidney (A2 donors to B and O recipients will be allowed if the site has the ability to confirm A2 subtype)
• Subject will receive a kidney from a donation after cardiac death (DCD) donor
• Subject has a predicted Irish model risk of DGF < 25%
• Female subjects who are pregnant or breast feeding
• Female subjects of child bearing potential who are unable or unwilling to use a medically acceptable form of contraception
• Subjects with a history of human immunodeficiency virus (HIV), or active hepatitis C virus (HCV) or hepatitis B virus (HBV) infection
• Subjects with active bacterial or other infection which is clinically significant in the opinion of the Investigator
• Subjects with a history of splenectomy
• Subjects with unresolved meningococcal disease
• Subjects with an unresolved systemic bacterial or fungal infection
• Subjects with known or suspected hereditary complement deficiency (for example, but not limited to: aHUS, PNH)
• Subject has a current malignancy or a history of any malignancy (within the past 5 years), except non-metastatic basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix that has been treated appropriately
• Subject has a history of or is believed by the Investigator to have used an illicit drug(s) and/or abused alcohol within 3 months prior to screening
• Subject has a psychiatric or physical illness that in the opinion of the Investigator would interfere with the ability of the subject to participate in the study