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

Cardiac Surgery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01256372
• Other study ID #: AP214-CS007
• Status: Completed
• Phase: Phase 2
• First received: December 5, 2010
• Last updated: March 14, 2012
• Start date: October 2010
• Est. completion date: August 2011

Study information

• Verified date: March 2012
• Source: Action Pharma A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: August 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Aortic Aneurysm
• Cardiac Surgery
• Coronary Artery Bypass
• Kidney Diseases
• Valve Surgery

Intervention

Drug:
• AP214
AP214
• Placebo
Placebo; intravenous infusion

Locations

Country	Name	City	State
Denmark	University Hospital Copenhagen, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Action Pharma A/S

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability	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	90 days	Yes
Primary	Efficacy	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	7 days	No
Secondary	Efficacy	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	90 days	No