Status:
COMPLETED
An Trial of Two Dosing Regimens of AP214 for the Prevention of Kidney Injury in Patients Undergoing Cardiac Surgery
Lead Sponsor:
Action Pharma A/S
Conditions:
Cardiac Surgery
Coronary Artery Bypass
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study investigates the effect of two dose-levels of AP214 on the prevention of (acute) kidney injury after cardiac surgery.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT01256372
Start Date
October 1 2010
End Date
August 1 2011
Last Update
March 15 2012
Active Locations (1)
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1
University Hospital Copenhagen, Rigshospitalet
Copenhagen, Denmark, 2100