Inclusion Criteria:
Adult patients receiving a kidney should satisfy the following to be considered part of the study:
Has the ability to understand the requirements of the study, is able to provide written informed consent (including consent for the use and disclosure of research related health information).
Male or female at least 18 years of age.
Has dialysis dependent renal failure initiated at least 2 months prior to transplantation.
Is to be a recipient of a transplant from a deceased donor (donation after cardio-circulatory determination of death criteria).
Is able to comply with the requirement of antibody induction therapy with rabbit polyclonal anti-thymocyte globulin or anti-CD25 (anti-IL2R) monoclonal antibodies per center standard of care.
A female subject is eligible to enter the study if she is:
Not pregnant or nursing
Of non-childbearing potential (i.e., post-menopausal defined as having been amenorrheic for at least 1 year prior to screening, or has had a bilateral tubal ligation at least 6 months prior to administration of study drug or bilateral oophorectomy or complete hysterectomy).
If of childbearing potential, must have a negative serum pregnancy test within 48 hours prior to transplant surgery and be using an effective means of contraception (per the site-specific guidelines or using 2 methods of birth control concurrently, whichever is more stringent) which will be continued until the Day 180 visit.
Male subjects with female partners of childbearing potential must agree to use an effective means of contraception (per the site-specific guidelines or use 2 methods of birth control concurrently, whichever is more stringent), which will be continued until the Day 180 visit. They will also agree not to donate sperm until 6 months after dosing.
Must be up-to-date on cancer screening according to site-specific guidelines and past medical history must be negative for biopsy-confirmed malignancy within 5 years of randomization, with the exception of adequately treated basal cell or squamous cell carcinoma in situ or carcinoma of the cervix in situ.
Must be willing to comply with the protocol procedures for the duration of the study, including scheduled follow-up visits and examinations.
Exclusion Criteria:
Adult patients receiving a kidney should not have any of the following to be considered part of the study:
Use of an investigational drug in the 30 days before surgery.
Participation in any other research study (drug or non-drug) without prior approval from the sponsor investigator.
Recipient of a live donor kidney or a kidney from a brain death donor (DBD) donor.
Recipient of donor kidney preserved with normothermic machine perfusion.
Scheduled to undergo multiorgan transplantation.
Has a planned transplant of kidneys that are implanted en-bloc (dual kidney transplantation).
Has planned transplant of dual kidneys (from the same donor) transplanted not en-bloc.
Has lost first kidney transplant due to graft thrombosis.
Is scheduled for transplantation of a kidney from a donor who is known to have received an investigational therapy under another IND/CTA for ischemic/reperfusion injury immediately prior to organ recovery.
Known hypersensitivity to human monoclonal antibodies or any of the study drug excipients.
Previous hypersensitivity to basiliximab, Campath-1H or antithymocyte globulin (ATG)
History of or known HIV, HBV (surface antigen), or HCV positivity
History of malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin, or cervical intraepithelial neoplasia.
Presence of clinically significant infections requiring continued therapy.
Positive screening for active tuberculosis.
Existence of any surgical or medical condition, other than the current transplantation which, in the opinion of the investigator, might significantly alter the distribution, metabolism or excretion of study medication.
Has a positive T- or B-cell cross-match by NIH anti-globulin lymphocytotoxicity method or CDC crossmatch method, if performed.
Has a positive T- or B-cell flow cross-match (over 250 channel shift) AND donor specific anti-HLA antibody (DSA) detected by flow cytometry (Luminex®) based antigen-specific anti-HLA antibody testing (over 1000 MFI) or by similar methodology, if performed.
History or presence of a medical condition or disease that in the investigator's assessment would place the patient at an unacceptable risk for study participation.
Lactating or pregnant woman.
Patient institutionalized by administrative or court order.
HLA or ABO incompatible kidney defined as a positive cytotoxic crossmatch or positive flow cross match.
Patients with known prothrombotic disorder (e.g. factor V leiden)
History of thrombosis or hypercoagulable state excluding access clotting
History of administration of C1INH containing products or recombinant C1INH within 15 days prior to study entry.
Patient with an abnormal Thromboelastogram- results must be reported out prior to dosing
Patients on warfarin or other anti-coagulants or anti-platelets, such as Plavix, low molecular weight heparin
Patients with known contraindication to treatment with C1INH
Patients with abnormal platelet count or known abnormal platelet function function (PLT>500,000)
Patients belonging to vulnerable populations: refers to but not limited to children, minors, pregnant women, prisoners, terminally ill patients, comatose, physically and intellectually challenged individuals, institutionalized, visual or hearing impaired, refugees, international research, and educationally disabled healthy volunteers.
Exclusion Criteria for Donor Kidney:
Donor who is known to have received an investigational drug for I-R injury or graft rejection (immunosuppressant) in the 48h before organ recovery.
Participation in any other research study (drug or non-drug).
Sex/Gender
Sexes Eligible for Study: All