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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01256372
Recruitment Status : Completed
First Posted : December 8, 2010
Last Update Posted : March 15, 2012
Information provided by (Responsible Party):
Action Pharma A/S

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

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, 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
Study Start Date : October 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Experimental: AP214; dose-level 1
AP214; dose-level 1
Drug: AP214

Experimental: AP214; dose-level 2
AP214; dose-level 2
Drug: AP214

Placebo Comparator: Placebo to AP214
Drug: Placebo
Placebo; intravenous infusion

Primary Outcome Measures :
  1. Safety and Tolerability [ Time Frame: 90 days ]
    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

  2. Efficacy [ Time Frame: 7 days ]
    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 :
  1. Efficacy [ Time Frame: 90 days ]
    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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01256372

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

Responsible Party: Action Pharma A/S Identifier: NCT01256372     History of Changes
Other Study ID Numbers: AP214-CS007
First Posted: December 8, 2010    Key Record Dates
Last Update Posted: March 15, 2012
Last Verified: March 2012

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

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