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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Action Pharma A/S
ClinicalTrials.gov Identifier:
NCT01256372
First received: December 5, 2010
Last updated: March 14, 2012
Last verified: March 2012
History of Changes
  Purpose

This study investigates the effect of two dose-levels of AP214 on the prevention of (acute) kidney injury after cardiac surgery.


Condition Intervention Phase
Cardiac Surgery
Coronary Artery Bypass
Aortic Aneurysm
Valve Surgery
Kidney Diseases
 Drug: AP214
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: An Explorative Phase 2, Randomized, Double-Blind, Placebo-Controlled, Safety and Efficacy Trial of Two Dosing Regimens of AP214 for the Prevention of Kidney Injury in Patients Undergoing Cardiac Surgery

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Action Pharma A/S:

Primary Outcome Measures:
  • Safety and Tolerability [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    To assess the safety and tolerability of AP214 compared to placebo; by analysis of number and nature of Adverse Events (AEs), Serious Adverse Events (SAEs), changes in laboratory parameters and overall health status

  • Efficacy [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    To assess the effect of AP214 versus placebo on the maximal postoperative change in absolute values of Serum Creatinine (SCr) compared to baseline within the first 7 days after surgery or until discharge from hospital, whichever comes first


Secondary Outcome Measures:
  • Efficacy [ Time Frame: 90 days ] [ Designated as safety issue: No ]
    To assess the ability of AP214 compared to placebo to reduce postoperative changes in SCr, and eGFR at day 28, 60 and Day 90 and GFR at Day 90 compared to baseline


Enrollment: 77
Study Start Date: October 2010
Study Completion Date: August 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: AP214; dose-level 1
AP214; dose-level 1
 Drug: AP214
AP214
Experimental: AP214; dose-level 2
AP214; dose-level 2
 Drug: AP214
AP214
Placebo Comparator: Placebo to AP214
Placebo
 Drug: Placebo
Placebo; intravenous infusion

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ligation, hysterectomy, bilateral salpingectomy), regardless of ethnicity.
  3. Patients undergoing combined coronary artery bypass grafting (CABG) surgery and surgery of one or more cardiac valve (valve(s) surgery), or
  4. Patients undergoing surgery of more than one cardiac valve (valves surgery), or
  5. Patients undergoing surgery of the aortic root or ascending part of the aorta, or
  6. Patients undergoing surgery of the aortic root or ascending part of the aorta, combined with CABG and/or valve(s) surgery, or
  7. 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:

  1. Cardiac surgery to be performed "off pump" without cardiopulmonary bypass.
  2. Cardiac surgery to be performed with hypothermic circulatory arrest.
  3. Confirmed or suspected endocarditis.
  4. EF ≤ 20%, evaluated within 2 months prior to screening visit.
  5. Requiring a reoperation on one of the valves within 3 months following the original valve surgical procedure.
  6. Active peptic ulcer disease and gastritis.
  7. Receiving dopamine, adrenalin or noradrenalin at any dose at any time 14 days prior to Day of surgery.
  8. Known or suspected hypersensitivity to the investigational medicinal product.
  9. Current participation in any other interventional clinical trial.
  10. Previously dosed with AP214.
  11. Use of investigational medicinal products within the previous 6 months.
  12. Body weight above 130 kg.
  13. History of any organ transplant.
  14. Women who are of childbearing potential, pregnant, or breast-feeding.
  15. Current abuse of alcohol or substance, according to the investigator's medical judgment.
  16. Has a mental incapacity or language barriers precluding adequate understanding of trial procedures.
  17. Any history of cancer within the last 2 years
  18. Any history of dialysis.
  19. Is considered by the Investigator unsuitable to participate in the trial for any other reason, for instance due to a significant serious underlying condition.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01256372

Locations
Denmark
University Hospital Copenhagen, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Action Pharma A/S
Investigators
Study Director: Action Pharma Action Pharma A/S
  More Information

No publications provided

Responsible Party: Action Pharma A/S
ClinicalTrials.gov Identifier: NCT01256372     History of Changes
Other Study ID Numbers: AP214-CS007
Study First Received: December 5, 2010
Last Updated: March 14, 2012
Health Authority: United States: Food and Drug Administration
Denmark: Danish Medicines Agency

Keywords provided by Action Pharma A/S:
Cardiac surgery
Acute kidney injury

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Kidney Diseases
Vascular Diseases
 Cardiovascular Diseases
Aortic Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013