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TerminatedNCT00628264Updated Jun 1, 2009

Safety, Tolerability and Pharmacodynamics of AP214 Acetate in Patients Undergoing Cardiac Surgery

A Phase 2 interventional study of AP214 and Placebo in Cardiac Surgery, Coronary Artery Bypass Grafting and Valve Surgery, sponsored by Action Pharma A/S. Terminated at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-06-01.

Sponsored by Action Pharma A/S · Phase 2, Interventional, and Prevention

Why this study was terminated
The study was terminated due to a considerably lower recruitment rate than anticipated
Phase
Phase 2
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of the present research study is to investigate for the first time, the safety and tolerability of infusion doses of AP214 in subjects having heart surgery such as coronary bypass graft and/or valve repair or replacement surgery. AP214, the investigational drug, is being developed to potentially prevent post-surgical kidney injury after thoracic aortic aneurysm repair.

02

Conditions studied

  • Cardiac Surgery
  • Coronary Artery Bypass Grafting
  • Valve Surgery
  • Kidney Injury

Keywords

  • cardiac surgery
  • coronary artery bypass grafting
  • valve surgery
  • acute kidney injury
03

In context

Lead sponsor

Action Pharma A/S is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Has signed the trial specific informed consent form.
  2. Patients ≥ 18 years old, male or female, not of childbearing potential (postmenopausal or permanently sterilized e.g., tubal occlusion, hysterectomy, bilateral salpingectomy), regardless of ethnicity.
  3. Patients undergoing CABG, valve(s), CABG/valve 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.

Exclusion criteria

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 catheterization ≤ 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 90.
  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-hydroxytryptamine 3 (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 judgment
  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
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
75 participants (estimated)

Study arms

  • Experimental
    AP214

    Drug: AP214

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugAP214

    Three AP214 bolus infusions administered over 10 minutes (prior to skin incision, at time of clamp-release and 6 hours after clamp-release).

  • DrugPlacebo

    Three placebo bolus infusions administered over 10 minutes (prior to skin incision, at time of clamp-release and 6 hours after clamp-release).

06

What researchers measure

Primary outcomes

  1. To assess the safety and tolerability of AP214 administered as three 10-minute bolus infusions, in patients undergoing cardiac surgery that are at increased risk of AKI (descriptive analysis of AEs and SAEs from Day 0-14).

    Time frame: From day 0-14

  2. To assess the impact of AP214 on cardiac surgery induced systemic inflammatory response syndrome determined by the post-operative peak plasma concentrations of IL-6 and IL-10 from 0-24 hours

    Time frame: 0-24 hours

Secondary outcomes

  1. To assess the safety and tolerability of AP214 at an organ level as well as in terms of the overall mortality (heart, CNS, lung, wound, mortality)

    Time frame: Day 0-90

  2. To assess the impact of AP214 on cardiac surgery induced systemic inflammatory response syndrome (post-operative peak plasma concentrations of TNF-α and IL-8 and AUC for TNF-α, IL-6, IL-8 and IL-10).

    Time frame: 0-24 hours

  3. To assess the impact of AP214 for renal protection as measured by the development of post-surgical acute kidney injury (AKIN score)

    Time frame: Day 0-14

  4. To assess the impact of AP214 on the development of post-surgical left ventricular dysfunction (determined by changes in left ventricular function from pre to post coronary bypass by transesophageal echocardiography

    Time frame: 0-24 hours

07

Study locations

2 sites
  • Shands Hospital at Alachua General Hospital
    Gainesville, Florida 32601, United States
  • Shands Hopsital at University of Florida
    Gainesville, Florida 32610, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00628264
Lead sponsor
Action Pharma A/S
First posted
Mar 5, 2008
Start date
Mar 2008
Primary completion
Jun 2009 (estimated)
Completion
Jun 2009 (estimated)
Last update
Jun 1, 2009

Study contacts

Thomas M Beaver, MD, MPH
principal investigator · Division of Thoracic and Cardiovascular Surgery , University of Florida College of Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2009. You cannot join it, but the record below documents what was studied.

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