Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Alexion Pharmaceuticals, Inc.
With
CTI Clinical Trial and Consulting Services
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
Clareo Health | Prevention of Delayed Graft Function Using Eculizumab Therapy (PROTECT Study)
