Back to resultsAn Trial of Two Dosing Regimens of AP214 for the Prevention of Kidney Injury in Patients Undergoing Cardiac Surgery
Primary Purpose
Cardiac Surgery, Coronary Artery Bypass, Aortic Aneurysm
Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
AP214
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Cardiac Surgery focused on measuring Cardiac surgery, Acute kidney injury
Eligibility Criteria
Inclusion Criteria:
- Has signed the trial-specific informed consent form.
- 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.
- Patients undergoing combined coronary artery bypass grafting (CABG) surgery and surgery of one or more cardiac valve (valve(s) surgery), or
- Patients undergoing surgery of more than one cardiac valve (valves surgery), or
- Patients undergoing surgery of the aortic root or ascending part of the aorta, or
- Patients undergoing surgery of the aortic root or ascending part of the aorta, combined with CABG and/or valve(s) surgery, or
- 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:
- Cardiac surgery to be performed "off pump" without cardiopulmonary bypass.
- Cardiac surgery to be performed with hypothermic circulatory arrest.
- Confirmed or suspected endocarditis.
- EF ≤ 20%, evaluated within 2 months prior to screening visit.
- Requiring a reoperation on one of the valves within 3 months following the original valve surgical procedure.
- Active peptic ulcer disease and gastritis.
- Receiving dopamine, adrenalin or noradrenalin at any dose at any time 14 days prior to Day of surgery.
- Known or suspected hypersensitivity to the investigational medicinal product.
- Current participation in any other interventional clinical trial.
- Previously dosed with AP214.
- Use of investigational medicinal products within the previous 6 months.
- Body weight above 130 kg.
- History of any organ transplant.
- Women who are of childbearing potential, pregnant, or breast-feeding.
- Current abuse of alcohol or substance, according to the investigator's medical judgment.
- Has a mental incapacity or language barriers precluding adequate understanding of trial procedures.
- Any history of cancer within the last 2 years
- Any history of dialysis.
- Is considered by the Investigator unsuitable to participate in the trial for any other reason, for instance due to a significant serious underlying condition.
Sites / Locations
- University Hospital Copenhagen, Rigshospitalet
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
AP214; dose-level 1
AP214; dose-level 2
Placebo to AP214
Arm Description
AP214; dose-level 1
AP214; dose-level 2
Placebo
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01256372
Brief Title
An Trial of Two Dosing Regimens of AP214 for the Prevention of Kidney Injury in Patients Undergoing Cardiac Surgery
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 Type
Interventional
2. Study Status
Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Action Pharma A/S
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study investigates the effect of two dose-levels of AP214 on the prevention of (acute) kidney injury after cardiac surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Surgery, Coronary Artery Bypass, Aortic Aneurysm, Valve Surgery, Kidney Diseases
Keywords
Cardiac surgery, Acute kidney injury
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AP214; dose-level 1
Arm Type
Experimental
Arm Description
AP214; dose-level 1
Arm Title
AP214; dose-level 2
Arm Type
Experimental
Arm Description
AP214; dose-level 2
Arm Title
Placebo to AP214
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
AP214
Intervention Description
AP214
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo; intravenous infusion
Primary Outcome Measure Information:
Title
Safety and Tolerability
Description
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
Time Frame
90 days
Title
Efficacy
Description
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
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Efficacy
Description
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
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Has signed the trial-specific informed consent form.
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.
Patients undergoing combined coronary artery bypass grafting (CABG) surgery and surgery of one or more cardiac valve (valve(s) surgery), or
Patients undergoing surgery of more than one cardiac valve (valves surgery), or
Patients undergoing surgery of the aortic root or ascending part of the aorta, or
Patients undergoing surgery of the aortic root or ascending part of the aorta, combined with CABG and/or valve(s) surgery, or
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:
Cardiac surgery to be performed "off pump" without cardiopulmonary bypass.
Cardiac surgery to be performed with hypothermic circulatory arrest.
Confirmed or suspected endocarditis.
EF ≤ 20%, evaluated within 2 months prior to screening visit.
Requiring a reoperation on one of the valves within 3 months following the original valve surgical procedure.
Active peptic ulcer disease and gastritis.
Receiving dopamine, adrenalin or noradrenalin at any dose at any time 14 days prior to Day of surgery.
Known or suspected hypersensitivity to the investigational medicinal product.
Current participation in any other interventional clinical trial.
Previously dosed with AP214.
Use of investigational medicinal products within the previous 6 months.
Body weight above 130 kg.
History of any organ transplant.
Women who are of childbearing potential, pregnant, or breast-feeding.
Current abuse of alcohol or substance, according to the investigator's medical judgment.
Has a mental incapacity or language barriers precluding adequate understanding of trial procedures.
Any history of cancer within the last 2 years
Any history of dialysis.
Is considered by the Investigator unsuitable to participate in the trial for any other reason, for instance due to a significant serious underlying condition.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Action Pharma
Organizational Affiliation
Action Pharma A/S
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital Copenhagen, Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
An Trial of Two Dosing Regimens of AP214 for the Prevention of Kidney Injury in Patients Undergoing Cardiac Surgery
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