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

December 5, 2010
March 14, 2012
October 2010
June 2011   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01256372 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
An Trial of Two Dosing Regimens of AP214 for the Prevention of Kidney Injury in Patients Undergoing Cardiac Surgery
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Cardiac Surgery
  • Coronary Artery Bypass
  • Aortic Aneurysm
  • Valve Surgery
  • Kidney Diseases
  • Drug: AP214
    AP214
  • Drug: Placebo
    Placebo; intravenous infusion
  • Experimental: AP214; dose-level 1
    AP214; dose-level 1
    Intervention: Drug: AP214
  • Experimental: AP214; dose-level 2
    AP214; dose-level 2
    Intervention: Drug: AP214
  • Placebo Comparator: Placebo to AP214
    Placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
77
August 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01256372
AP214-CS007
Yes
Action Pharma A/S
Action Pharma A/S
Not Provided
Study Director: Action Pharma Action Pharma A/S
Action Pharma A/S
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP