Cardiac SurgeryPhase 2NCT00628264
Safety, Tolerability and Pharmacodynamics 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 United States.
Trial summary
The purpose of the present research study is to investigate for the first time, the safety and tolerability of infusion doses of AP214 in subjects having heart surgery such as coronary bypass graft and/or valve repair or replacement 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
- 75 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2008to Jun 2009
- 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 occlusion, hysterectomy, bilateral salpingectomy), regardless of ethnicity.
- Patients undergoing CABG, valve(s), CABG/valve 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 90.
- 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.
United States2 sites
Shands Hospital at Alachua General Hospital
Gainesville, Florida, 32601
Shands Hopsital at University of Florida
Gainesville, Florida, 32610
About this study
The purpose of the present research study is to investigate for the first time, the safety and tolerability of infusion doses of AP214 in subjects having heart surgery such as coronary bypass graft and/or valve repair or replacement surgery. AP214, the investigational drug, is being developed to potentially prevent post-surgical kidney injury after thoracic aortic aneurysm repair.
- Being tested
- AP214, Placebo
- Keywords
- cardiac surgery, coronary artery bypass grafting, valve 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 AP214 bolus infusions administered over 10 minutes (prior to skin incision, at time of clamp-release and 6 hours after clamp-release).
PlaceboDrug
Three placebo bolus infusions administered over 10 minutes (prior to skin incision, at time of clamp-release and 6 hours after clamp-release).
| Study group | Role | What they receive |
|---|---|---|
| AP214 | Experimental | Not described Receives: Drug: AP214 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of AP214 administered as three 10-minute bolus infusions, in patients undergoing cardiac surgery that are at increased risk of AKI (descriptive analysis of AEs and SAEs from Day 0-14).
Measured: From day 0-14
To assess the impact of AP214 on cardiac surgery induced systemic inflammatory response syndrome determined by the post-operative peak plasma concentrations of IL-6 and IL-10 from 0-24 hours
Measured: 0-24 hours
Secondary outcomes (4)
To assess the safety and tolerability of AP214 at an organ level as well as in terms of the overall mortality (heart, CNS, lung, wound, mortality)
Measured: Day 0-90
To assess the impact of AP214 on cardiac surgery induced systemic inflammatory response syndrome (post-operative peak plasma concentrations of TNF-α and IL-8 and AUC for TNF-α, IL-6, IL-8 and IL-10).
Measured: 0-24 hours
To assess the impact of AP214 for renal protection as measured by the development of post-surgical acute kidney injury (AKIN score)
Measured: Day 0-14
To assess the impact of AP214 on the development of post-surgical left ventricular dysfunction (determined by changes in left ventricular function from pre to post coronary bypass by transesophageal echocardiography
Measured: 0-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionJun 2009 (estimated)
- Study completionJun 2009 (estimated)
Why it stopped: The study was terminated due to a considerably lower recruitment rate than anticipated
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
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Action Pharma A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Thomas M Beaver, MD, MPH, Principal investigator, Division of Thoracic and Cardiovascular Surgery , University of Florida College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00628264
- Sponsor's protocol ID
- AP214-CS004
- Status last verified
- May 2009
- First submitted
- 25 Feb 2008
- Last updated
- 1 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Tolerability and Pharmacodynamics of AP214 Acetate in Patients Undergoing Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00628264
- Acronym / sponsor ID
- AP214-CS004
- Keywords
- cardiac surgery, coronary artery bypass grafting, valve surgery, acute kidney injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to a considerably lower recruitment rate than anticipated
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Action Pharma A/SIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Jun 2009 (estimated)
- First posted
- 5 Mar 2008 (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 for the first time, the safety and tolerability of infusion doses of AP214 in subjects having heart surgery such as coronary bypass graft and/or valve repair or replacement 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: AP214 |
| Placebo | Placebo comparator | Drug: Placebo |
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 occlusion, hysterectomy, bilateral salpingectomy), regardless of ethnicity.
- Patients undergoing CABG, valve(s), CABG/valve 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 AP214 bolus infusions administered over 10 minutes (prior to skin incision, at time of clamp-release and 6 hours after clamp-release). | Drug | AP214 |
| PlaceboThree placebo bolus infusions administered over 10 minutes (prior to skin incision, at time of clamp-release and 6 hours after clamp-release). | Drug | Placebo |
Primary outcome
To assess the safety and tolerability of AP214 administered as three 10-minute bolus infusions, in patients undergoing cardiac surgery that are at increased risk of AKI (descriptive analysis of AEs and SAEs from Day 0-14).
Time frame: From day 0-14
To assess the impact of AP214 on cardiac surgery induced systemic inflammatory response syndrome determined by the post-operative peak plasma concentrations of IL-6 and IL-10 from 0-24 hours
Time frame: 0-24 hours
4 secondary outcomes
To assess the safety and tolerability of AP214 at an organ level as well as in terms of the overall mortality (heart, CNS, lung, wound, mortality)
Time frame: Day 0-90
To assess the impact of AP214 on cardiac surgery induced systemic inflammatory response syndrome (post-operative peak plasma concentrations of TNF-α and IL-8 and AUC for TNF-α, IL-6, IL-8 and IL-10).
Time frame: 0-24 hours
To assess the impact of AP214 for renal protection as measured by the development of post-surgical acute kidney injury (AKIN score)
Time frame: Day 0-14
To assess the impact of AP214 on the development of post-surgical left ventricular dysfunction (determined by changes in left ventricular function from pre to post coronary bypass by transesophageal echocardiography
Time frame: 0-24 hours
Results and safety
The study was stopped early (reason given: The study was terminated due to a considerably lower recruitment rate than anticipated). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2009.
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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.
Thomas M Beaver, MD, MPH principal investigator
Division of Thoracic and Cardiovascular Surgery , University of Florida College of Medicine
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 United States.
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: stopped early, as of the sponsor's last update on 1 Jun 2009. 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 United States. 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 was stopped early (reason given: The study was terminated due to a considerably lower recruitment rate than anticipated). Results are not available in the source record.
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 the safety and tolerability of AP214 administered as three 10-minute bolus infusions, in patients undergoing cardiac surgery that are at increased risk of AKI (descriptive analysis of AEs and SAEs from Day 0-14). (time frame: From day 0-14). 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 1 Jun 2009.