A Three-Part, Multi-Centre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Sequential Adaptive, Phase II Study to Evaluate the Safety, Tolerability and Efficacy of OPN-305, a Humanised Monoclonal Antibody That Blocks Toll-Like Receptor 2, in Renal Transplant Patients at High Risk of Delayed Graft Function

Study start date: October 1, 2012

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