Clinical trial NCT02145182 (phase 2/phase 3, status: completed)
Conditions: delayed graft function
ICD codes: R94.120, R94.121, H02.59, H57.00, H57.09, F82, H81.8X3
Drugs: eculizumab, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        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 <6 years of age

          -  Participant to receive a dual kidney transplant (from same donor, including en bloc)

          -  Participant to receive a living donor kidney

          -  Participant is highly sensitized (high risk to develop acute antibody-mediated
             rejection) 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

          -  Participant has received a previous transplant

          -  Participant is participating in another investigational study

          -  Participant has a body mass index >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