Cardiac SurgeryPhase 2NCT01256372
An Trial of Two Dosing Regimens of AP214 for the Prevention of Kidney Injury in Patients Undergoing Cardiac Surgery
A Phase 2 study testing AP214 in people with Cardiac Surgery and Coronary Artery Bypass, run by Action Pharma A/S at 1 site in Denmark.
Trial summary
This study investigates the effect of two dose-levels of AP214 on the prevention of (acute) kidney injury after 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, Aortic Aneurysm
- 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
- 77 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2010to Aug 2011
- 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 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
Who cannot join
- 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.
Show all 19Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
This study investigates the effect of two dose-levels of AP214 on the prevention of (acute) kidney injury after cardiac surgery.
- Being tested
- AP214, Placebo
- Keywords
- Cardiac surgery, Acute kidney injury
- Medical subject headings
- Aortic Aneurysm, Kidney Diseases, Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AP214Drug
AP214
PlaceboDrug
Placebo; intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| AP214; dose-level 1 | Experimental | AP214; dose-level 1 Receives: Drug: AP214 |
| AP214; dose-level 2 | Experimental | AP214; dose-level 2 Receives: Drug: AP214 |
| Placebo to AP214 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 days
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
Measured: 7 days
Secondary outcomes (1)
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
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2010 (estimated)
- Study startOct 2010
- Primary completionJun 2011
- Study completionAug 2011
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Action Pharma A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Action Pharma, Study director, Action Pharma A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01256372
- Sponsor's protocol ID
- AP214-CS007
- Status last verified
- Mar 2012
- First submitted
- 5 Dec 2010
- Last updated
- 15 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01256372
- Acronym / sponsor ID
- AP214-CS007
- Keywords
- Cardiac surgery, Acute kidney injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Action Pharma A/SIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 8 Dec 2010 (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.
This study investigates the effect of two dose-levels of AP214 on the prevention of (acute) kidney injury after cardiac surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AP214; dose-level 1 | Experimental | Drug: AP214AP214; dose-level 1 |
| AP214; dose-level 2 | Experimental | Drug: AP214AP214; dose-level 2 |
| Placebo to AP214 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 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 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
Key exclusion criteria (19 listed)
- 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.
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 |
|---|---|---|
| AP214AP214 | Drug | AP214; dose-level 1, AP214; dose-level 2 |
| PlaceboPlacebo; intravenous infusion | Drug | Placebo to AP214 |
Primary outcome
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
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
1 secondary outcome
Efficacy
Time frame: 90 days
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 15 Mar 2012.
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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.
Action Pharma study director
Action Pharma A/S
1 site 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, run by Action Pharma A/S at 1 site 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 7 inclusion and 19 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 15 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Safety and Tolerability (time frame: 90 days). 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 15 Mar 2012.