Placebo-Controlled Study to Evaluate the Safety and Efficacy of OPN-305 in Preventing Delayed Renal Graft Function

Inclusion criteria INCLUSION CRITERIA FOR TRANSPLANT RECIPIENTS * First or second renal transplant recipient - for second renal transplantations; * The second transplant should NOT be due to rejection * Panel Reactive Antibody (PRA) should be \<10% * Minimum 3 months since the loss of the first transplanted kidney * Dialysis-dependent at the time of transplantation as documented by: * Requirement for at least 2 dialysis sessions/week in the 56 days before transplantation INCLUSION CRITERIA FOR DONOR KIDNEY: * The donor kidney must be considered compatible according to local transplant guidelines * An ECD donor defined as: o Extended Criteria Donor defined as: * Donor ≥60 years of age * Donor 50-59 years of age with two of three of the following criteria present: * Death due to cerebrovascular accident * Pre-existing history of systemic hypertension * Terminal creatinine \> 1.5mg/dL (132.6 µmol/L) * Kidney allograft maintained in cold storage with or without machine perfusion Exclusion Criteria EXCLUSION CRITERIA FOR TRANSPLANT RECIPIENTS: * Use of an investigational drug in the 30 days before Study Day 1 * Participation in any other research * Known hypersensitivity to human monoclonal antibodies or any of the study-drug excipients * Previous hypersensitivity to basiliximab or anti-thymocyte globulin (ATG) * History or known HIV, HBV, or HCV-positive * History of malignancy within the last five years, except excised squamous or basal cell carcinoma of the skin or cervical intraepithelial neoplasia * Scheduled to undergo multi-organ transplantation * Planned dual kidney transplantation * Presence of clinically significant infections requiring continued therapy * 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 * Presence of uncontrolled diabetes mellitus. * Current drug and/or alcohol abuse * 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 EXCLUSION CRITERIA FOR ALL DONOR KIDNEYS * DCD or SCD donor kidney * Terminal creatinine \>3mg/dL * 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 (drug or non-drug) * Kidney donor \<5 years of age or \<20kg body weight * Living donor allograft * HLA or ABO incompatible kidney as defined by a negative cytotoxic crossmatch * Donor institutionalized by administrative or court order