Pharmacokinetics of AP214 Acetate in Patients Undergoing Cardiac Surgery (NCT00903604) | Clinical Trial Compass
CompletedPhase 2
Pharmacokinetics of AP214 Acetate in Patients Undergoing Cardiac Surgery
Denmark42 participantsStarted 2009-05
Plain-language summary
The purpose of the present research study is to investigate the pharmacokinetics, as well as safety, tolerability and pharmacodynamics of different ascending dosing regimens of AP214 in patients undergoing cardiac surgery. AP214, the investigational drug, is being developed to potentially prevent post-surgical kidney injury after thoracic aortic aneurysm repair.
Who can participate
Age range18 Years
SexALL
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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.
✓. Cleveland Clinic Renal Score ≥ 2 (higher than average risk for AKI).
✓. EF ≥ 30%, evaluated within 2 months prior to screening visit.
Exclusion criteria
✕. Cardiac surgery to be performed "off pump" without cardiopulmonary bypass.
✕. Circulatory arrest in connection with aortic root or ascending aortic aneurysm repair surgery.
✕. Confirmed or suspected endocarditis.
✕. Requiring a reoperation on one of the valves within 3 months following the original valve surgical procedure.
✕. Receiving Aprotinin during the trial, from Screening to Day 90.
✕. Having undergone cardiovascular catheterization ≤ 48 hours prior to scheduled surgery.
✕. Active peptic ulcer disease and gastritis.
✕
What they're measuring
1
To assess in patients the pharmacokinetics of AP214 administered as three 10-minute infusions in patients undergoing cardiac surgery.
Timeframe: Day 0 to Day 1
2
To assess the safety and tolerability of AP214, defined as a descriptive analysis of AEs and SAEs (including analysis of severity and relationship to trial drug)