Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Heeger, Peter, M.D.
With
Alexion Pharmaceuticals, Inc.
Icahn School of Medicine at Mount Sinai
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age 18 years or older
Weight \> 40 kg
Male or Female
Recipient of first deceased donor kidney
Able to provide written informed consent
Transplant candidate as per site specific guidelines
Dialysis dependent renal failure (initiated more than 2 months prior to transplant)
Recipients of kidneys defined as:
1. Extended Criteria Donor (ECD) kidney with brain death: Kidney donors 60 years of age or older; or donors aged 50-59 years and have two of the following features: Hypertension, terminal serum creatinine \> 1.5 mg/dL, or death from cerebrovascular accident (CVA), OR
2. Standard Criteria Donor (SCD) kidney with actual cold ischemia time (CIT) 18 - 40 hours
You may not be if
Patient is planned to receive a multi-organ transplant
Kidney from donor \< 6 years of age
Dual kidney transplant (from same donor, including en bloc)
Living donor kidney transplant
Recipients with donor-specific anti-HLA antibodies of more than 3,000 MFI
Participation in another investigational drug study
Recipient BMI \> 40
ABO incompatible
DCD (donor with cardiac death) Donor
Women who are pregnant or breast-feeding
Women of child bearing potential who are unable or unwilling to use a medically acceptable form of contraception (defined as the use of oral, injected or implanted hormonal methods of contraception, intrauterine device (IUD)or intrauterine system (IUS), barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository)
Patients with HBsAg-positive status, HCV infection, or HIV infection
Patients with atypical hemolytic uremic syndrome (aHUS) or C3 glomerulonephritis (C3GN)
Active bacterial or other infection which is clinically significant in the opinion of the investigator
Patients with history of splenectomy
Patients with history of meningococcal disease
Patients allergic to or unable to tolerate Ciprofloxacin
Patients unable or unwilling to receive vaccination against meningitis prior to study drug administration
Patients with a known or suspected hereditary complement deficiency
Patients with a history of cancer (other than non melanoma skin cancers) within the last five years
Donors of more than 70 years of age
Subjects with a psychiatric or physical illness which in the opinion of the Investigator would interfere with their ability to participate in the study.
