Cardiac SurgeryPhase 2NCT00903604
Pharmacokinetics of AP214 Acetate in Patients Undergoing Cardiac Surgery
A Phase 2 study testing AP214 in people with Cardiac Surgery and Coronary Artery Bypass Grafting, run by Action Pharma A/S at 2 sites in Denmark.
Trial summary
The purpose of the present research study is to investigate the pharmacokinetics, as well as safety, tolerability and pharmacodynamics of different ascending dosing regimens of AP214 in patients undergoing cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery, Coronary Artery Bypass Grafting, Valve Surgery
- What is being tested?
- AP214
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 2 sitesDenmark
- Study dates
- May 2009to Jun 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 CABG, valve(s), CABG/valve(s) and/or aortic root or ascending aortic aneurysm repair surgery.
- Cleveland Clinic Renal Score ≥ 2 (higher than average risk for AKI).
- EF ≥ 30%, evaluated within 2 months prior to screening visit.
Who cannot join
- Cardiac surgery to be performed "off pump" without cardiopulmonary bypass.
- Circulatory arrest in connection with aortic root or ascending aortic aneurysm repair surgery.
- Confirmed or suspected endocarditis.
- Requiring a reoperation on one of the valves within 3 months following the original valve surgical procedure.
- Receiving Aprotinin during the trial, from Screening to Day 90.
- Having undergone cardiovascular catheterization ≤ 48 hours prior to scheduled surgery.
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- Active peptic ulcer disease and gastritis.
- Hemoccult positive stools, hematological, bleeding, and coagulation disorders.
- Receiving dopamine at renal doses (2-4 mcg/kg/min), from Screening to Day of surgery.
- S-Creatinine greater than 2.1 mg/dl.
- Known or suspected hypersensitivity to the investigational medicinal product.
- Known or suspected hypersensitivity to Ondansetron or other selective 5-hydroxytryptamine 3 (5-HT3) receptor antagonists.
- 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 140 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.
- Is considered by the Investigator unsuitable to participate in the trial for any other reason, for instance due to a significant serious underlying condition.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of Cardiac and Thoracic Surgery, Copenhagen University Hospital, Rigshospitalet
Copenhagen, 2100
Odense University Hospital, Department of Cardiac, Thoracic and Vascular Surgery
Odense, 5000
About this study
The purpose of the present research study is to investigate the pharmacokinetics, as well as safety, tolerability and pharmacodynamics of different ascending dosing regimens of AP214 in patients undergoing cardiac surgery. AP214, the investigational drug, is being developed to potentially prevent post-surgical kidney injury after thoracic aortic aneurysm repair.
- Conditions
- Cardiac Surgery, Coronary Artery Bypass Grafting, Valve Surgery, Aortic Root or Ascending Aortic Aneurysm Repair Surgery
- Being tested
- AP214, Placebo
- Keywords
- Cardiac surgery, coronary artery bypass grafting, valve surgery, aortic root or ascending aortic aneurysm repair surgery, Acute kidney injury
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AP214Drug
Three 10-minutes infusions of sequential ascending dosages of AP214
PlaceboDrug
Three 10-minutes infusions of isotonic saline solution
| Study group | Role | What they receive |
|---|---|---|
| AP214 | Experimental | Infusions of sequential ascending dosages of AP214 Receives: Drug: AP214 |
| Placebo | Placebo comparator | Infusions of saline solution Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess in patients the pharmacokinetics of AP214 administered as three 10-minute infusions in patients undergoing cardiac surgery.
Measured: Day 0 to Day 1
To assess the safety and tolerability of AP214, defined as a descriptive analysis of AEs and SAEs (including analysis of severity and relationship to trial drug)
Measured: Day 0-90
Secondary outcomes (6)
To assess effect of AP214 on cardiac surgery induced systemic inflammation o determined by the post-operative peak plasma concentrations of TNF-α, IL-6, IL-8, and IL-10, and area under the curve (AUC) for TNF-α, IL-6, IL-8, and IL-10
Measured: 0-24 hours
To assess effect of AP214 on development of post-surgical acute kidney injury (AKI), where AKI is evaluated by evaluation of serum creatinine values, urine output and renal replacement therapy free days.
Measured: Day 0 - Day 30
To assess the safety and tolerability of AP214 on standard safety laboratory data
Measured: Day 0-14
To assess the safety and tolerability of AP214 on vital signs
Measured: Day 0-90
To assess safety and tolerability of AP214 in terms of mortality by evaluation of overall mortality
Measured: Day 0-90
To assess the effect of AP214 at an organ level (CNS, heart, lung, and wound healing)as well as systemically.
Measured: Day 0-90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2009 (estimated)
- Study startMay 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Action Pharma A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Daniel Steinbrüchel, Professor, Principal investigator, Department of Cardiac and Thoracic Surgery, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00903604
- Sponsor's protocol ID
- AP214-CS005
- Status last verified
- May 2011
- First submitted
- 15 May 2009
- Last updated
- 17 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of AP214 Acetate in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00903604
- Acronym / sponsor ID
- AP214-CS005
- Conditions
- Cardiac Surgery, Coronary Artery Bypass Grafting, Valve Surgery, Aortic Root or Ascending Aortic Aneurysm Repair Surgery
- Keywords
- Cardiac surgery, coronary artery bypass grafting, valve surgery, aortic root or ascending aortic aneurysm repair surgery, Acute kidney injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Action Pharma A/SIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 18 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the present research study is to investigate the pharmacokinetics, as well as safety, tolerability and pharmacodynamics of different ascending dosing regimens of AP214 in patients undergoing cardiac surgery. AP214, the investigational drug, is being developed to potentially prevent post-surgical kidney injury after thoracic aortic aneurysm repair.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AP214 | Experimental | Drug: AP214Infusions of sequential ascending dosages of AP214 |
| Placebo | Placebo comparator | Drug: PlaceboInfusions of saline solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 CABG, valve(s), CABG/valve(s) and/or aortic root or ascending aortic aneurysm repair surgery.
- Cleveland Clinic Renal Score ≥ 2 (higher than average risk for AKI).
- EF ≥ 30%, evaluated within 2 months prior to screening visit.
Key exclusion criteria (21 listed)
- Cardiac surgery to be performed "off pump" without cardiopulmonary bypass.
- Circulatory arrest in connection with aortic root or ascending aortic aneurysm repair surgery.
- Confirmed or suspected endocarditis.
- Requiring a reoperation on one of the valves within 3 months following the original valve surgical procedure.
- Receiving Aprotinin during the trial, from Screening to Day 90.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AP214Three 10-minutes infusions of sequential ascending dosages of AP214 | Drug | AP214 |
| PlaceboThree 10-minutes infusions of isotonic saline solution | Drug | Placebo |
Primary outcome
To assess in patients the pharmacokinetics of AP214 administered as three 10-minute infusions in patients undergoing cardiac surgery.
Time frame: Day 0 to Day 1
To assess the safety and tolerability of AP214, defined as a descriptive analysis of AEs and SAEs (including analysis of severity and relationship to trial drug)
Time frame: Day 0-90
6 secondary outcomes
To assess effect of AP214 on cardiac surgery induced systemic inflammation o determined by the post-operative peak plasma concentrations of TNF-α, IL-6, IL-8, and IL-10, and area under the curve (AUC) for TNF-α, IL-6, IL-8, and IL-10
Time frame: 0-24 hours
To assess effect of AP214 on development of post-surgical acute kidney injury (AKI), where AKI is evaluated by evaluation of serum creatinine values, urine output and renal replacement therapy free days.
Time frame: Day 0 - Day 30
To assess the safety and tolerability of AP214 on standard safety laboratory data
Time frame: Day 0-14
To assess the safety and tolerability of AP214 on vital signs
Time frame: Day 0-90
To assess safety and tolerability of AP214 in terms of mortality by evaluation of overall mortality
Time frame: Day 0-90
To assess the effect of AP214 at an organ level (CNS, heart, lung, and wound healing)as well as systemically.
Time frame: Day 0-90
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Steinbrüchel, Professor principal investigator
Department of Cardiac and Thoracic Surgery, Copenhagen University Hospital, Rigshospitalet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AP214 in people with Cardiac Surgery and Coronary Artery Bypass Grafting, run by Action Pharma A/S at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess in patients the pharmacokinetics of AP214 administered as three 10-minute infusions in patients undergoing cardiac surgery. (time frame: Day 0 to Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2011.