Pharmacokinectics of AP214 Acetate in patients undergoing cardiac surgery.A randomized, double-blind, placebo-controlled sequential ascending dose trialinvestigating pharmacokinetics, as well as safety, tolerability and pharmacodynamics of three dosing regimens of AP214 administered intravenously

• Conditions: Action Pharma A/S is developing AP214 Acetate for the prevention of postsurgical kidney injury after thoracic aortic aneurysm repair surgery. In phase 2:Patients undergoing cardiac surgery, defined as coronary artery bypass grafting (CABG), valve(s), CABG/valve(s) and/or aortic root or ascending aortic aneurysm repair surgery with higher than average risk for severe acute kidney injury (AKI).; MedDRA version: 9.1Level: LLTClassification code 10056675Term: Postoperative renal failure

• Registration Number: EUCTR2008-006968-11-DK
• Lead Sponsor: Action Pharma A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-30
• Last Update Posted: 11 February 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1.Has signed the trial specific informed consent form.
2.Patients 18 to 80 years old, male or female, not of childbearing potential
(postmenopausal or permanently sterilized, e.g. tubal ligation,
hysterectomy, bilateral salpingectomy), regardless of ethnicity.
3.Patients undergoing CABG, valve(s), CABG/valve(s) and/or aortic root or
ascending aortic aneurysm repair surgery.
4.Cleveland Clinic Renal Score = 2 (higher than average risk for AKI).
5.EF = 30%, evaluated within 2 months prior to screening visit.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Cardiac surgery to be performed off pump” without cardiopulmonary
bypass.
2.Circulatory arrest in connection with aortic root or ascending aortic
aneurysm repair surgery.
3.Confirmed or suspected endocarditis.
4.Requiring a reoperation on one of the valves within 3 months following the
original valve surgical procedure.
5.Receiving Aprotinin during the trial, from screening to Day 90.
6.Having undergone cardiovascular catherization = 48 hours prior to
scheduled surgery.
7.Active peptic ulcer disease and gastritis.
8.Hemoccult positive stools, hematological, bleeding, and coagulation
disorders.
9.Receiving dopamine at renal doses (2-4 mcg/kg/min), from screening to
Day of surgery.
10.S-Creatinine greater than 2.1 mg/dl.
11.Known or suspected hypersensitivity to the investigational medicinal
product.
12.Known or suspected hypersensitivity to ondansetron or other selective 5-
HT3 receptor antagonists
13.Current participation in any other interventional clinical trial.
14.Previously dosed with AP214.
15.Use of investigational medicinal products within the previous 6 months.
16.Body weight above 140 kg.
17.History of any organ transplant.
18.Women who are of childbearing potential, pregnant or breast-feeding.
19.Current abuse of alcohol or substance, according to the investigator’s
medical judgement.
20.Has a mental incapacity or language barriers precluding adequate
understanding of trial procedures.
21.Is considered by the Investigator unsuitable to participate in the trial for
any other reason, for instance due to a significant serious underlying
condition

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified