Prevention of Delayed Graft Function Using Eculizumab Therapy (PROTECT Study)

Inclusion Criteria

• Male or female, 18 years or older
• Has dialysis-dependent renal failure (initiated more than 2 months prior to transplant)
• Participant is to receive a first kidney transplant from a standard criteria donor or expanded criteria donor deceased donor with a DGF risk score using the Irish scale of ≥25% (to be determined prior to surgery and before randomization)
• Able to provide written informed consent
• Willing and able to comply with the requirements of the study protocol
• Female participants of child-bearing potential must have a negative serum pregnancy test (serum beta-human chorionic gonadotropin) 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

• Participant to receive a multi-organ transplant
• Participant to receive kidney(s) from donors 40 kilograms/square meter at screening
• Participant 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)
• Participant will receive a kidney from a donation after cardiac death donor
• Participant has a predicted Irish model risk of DGF <25%
• Female participants who are pregnant or breast feeding
• Female participants of child bearing potential who are unable or unwilling to use a medically acceptable form of contraception
• Participants with a history of human immunodeficiency virus, or active hepatitis C virus or hepatitis B virus infection
• Participants with active bacterial or other infection which is clinically significant in the opinion of the Investigator
• Participants with a history of splenectomy
• Participants with unresolved meningococcal disease
• Participants with an unresolved systemic bacterial or fungal infection
• Participants with known or suspected hereditary complement deficiency (for example, but not limited to: atypical hemolytic uremic syndrome, paroxysmal nocturnal hemoglobinuria)
• Participant 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
• Participant 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
• Participant has a psychiatric or physical illness that in the opinion of the Investigator would interfere with the ability of the participant to participate in the study