An Trial of Two Dosing Regimens of AP214 for the Prevention of Kidney Injury in Patients Undergoing Cardiac Surgery

Exclusion Criteria

• •1. Cardiac surgery to be performed "off pump" without cardiopulmonary bypass.
• •2. Cardiac surgery to be performed with hypothermic circulatory arrest.
• •3. Confirmed or suspected endocarditis.
• •4. EF ≤ 20%, evaluated within 2 months prior to screening visit.
• •5. Requiring a reoperation on one of the valves within 3 months following the original valve surgical procedure.
• •6. Active peptic ulcer disease and gastritis.
• •7. Receiving dopamine, adrenalin or noradrenalin at any dose at any time 14 days prior to Day of surgery.
• •8. Known or suspected hypersensitivity to the investigational medicinal product.
• •9. Current participation in any other interventional clinical trial.
• •10. Previously dosed with AP214.
• •11. Use of investigational medicinal products within the previous 6 months.
• •12. Body weight above 130 kg.
• •13. History of any organ transplant.
• •14. Women who are of childbearing potential, pregnant, or breast-feeding.
• •15. Current abuse of alcohol or substance, according to the investigator's medical judgment.
• •16. Has a mental incapacity or language barriers precluding adequate understanding of trial procedures.
• •17. Any history of cancer within the last 2 years
• •18. Any history of dialysis.
• •19. Is considered by the Investigator unsuitable to participate in the trial for any other reason, for instance due to a significant serious underlying condition.