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

Inclusion criteria

• Has signed the trial-specific informed consent form.
• Patients ≥ 18 years old, male or female, not of childbearing potential (postmenopausal or permanently sterilized, e.g. tubal ligation, hysterectomy, bilateral salpingectomy), regardless of ethnicity.
• Patients undergoing combined coronary artery bypass grafting (CABG) surgery and surgery of one or more cardiac valve (valve(s) surgery), or
• Patients undergoing surgery of more than one cardiac valve (valves surgery), or
• Patients undergoing surgery of the aortic root or ascending part of the aorta, or
• Patients undergoing surgery of the aortic root or ascending part of the aorta, combined with CABG and/or valve(s) surgery, or
• Patients with stage III chronic kidney disease (eGFR 30-59 ml/min determined by the Modification of Diet in Renal Disease (MDRD formula)) undergoing CABG or Valve surgery

Exclusion criteria

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