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