Clinical Trials

Inclusion Criteria:

• All patients must provide written informed consent using an Institutional Review Board/Independent Ethics Committee approved consent form, and must understand and be willing and able to comply with the requirements of the study, including screening procedures and all required study visits.
• Males and females ≥ 18 years of age.
• Renal failure requiring hemodialysis or peritoneal dialysis initiated at least 3 months prior to transplantation.
• Patient is to be the recipient of a first kidney transplant from a deceased donor.
• Study drug can be administered starting within 30 hours after restoration of blood flow to the engrafted kidney.
• Body mass index < 40 based on patient’s body weight. Body weight and height parameters obtained within 7 days prior to study entry may be used.
• Estimated donor organ cold ischemia time < 30 hours (for PMP kidneys < 40 hours).
• Females of childbearing potential (including perimenopausal women who have had a menstrual period within 1 year):
  • Must have a negative serum pregnancy test prior to transplantation.
  • Must agree to use 2 forms of effective birth control regimen (at least one-barrier method) during the initial 30-day study period OR agree to maintain total abstinence throughout the initial 30-day study period.
• Male patients must agree to use condoms or other suitable means of pregnancy prevention such as abstinence during the initial 30-day study period.
• Patient has poor renal function in the first 24 hours post-transplantation based on an average urine output (UO) of < 50 mL/hour over any 8 consecutive hours, to maximize the likelihood that the patient requires dialysis within the first 7 days post-transplant, irrespective of pre-transplant donor and recipient risk factors.
• Reason for low UO is not due to structural or vascular abnormalities which, when indicated should be confirmed with a renal ultrasound with Doppler study and/or vascular or urinary tract contrast studies.

Exclusion Criteria:

• Scheduled for multiple organ transplantation or prior recipient of a transplanted organ.
• Recipient of an ABO-incompatible kidney.
• Recipient of pediatric en bloc kidney transplantation or adult or pediatric planned transplant of dual kidneys (from the same donor) not transplanted en bloc.
• Recipient of a kidney preserved by normothermic PMP.
• Has measurable donor-specific antibody or positive cross-match requiring desensitization prior to transplantation or deviation from standard immunosuppressive therapy.
• Currently participating in or has participated in an investigational drug or medical device study within 30 days or five drug half-lives, whichever is longer, prior to enrollment into this study. Patients cannot be given another investigational agent during the course of this study (through Day 360). Patients may participate in another concurrent study only if that study is a non-interventional, observational investigation.
• Concurrent sepsis or active bacterial infection.
• Has an active malignancy or history within 5 years prior to enrollment in the study of solid, metastatic or hematologic malignancy with the exception of basal or squamous cell carcinoma in situ of the skin that has been adequately treated.
• Female who is breastfeeding.
• History of positive human immunodeficiency virus test.
• Requires treatment with the cytochrome P450 (CYP) 1A2 inhibitors, ciprofloxacin and/or fluvoxamine (Luvox®).
• Unwilling or unable to comply with the protocol or to cooperate fully with the Investigator or the site personnel.
• Not deemed medically appropriate for the study in the opinion of the Investigator.