Non-anaemic Patients Undergoing Cardiac SurgeryPhase 3CABG-01NCT01563367
A Prospective, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by Infusions to Non-Anaemic Patients Undergoing Elective or Sub-Acute Coronary Artery Bypass Graft, Valve Replacement or a Combination Thereof
A Phase 3 study testing Iron isomaltoside 1000 (Monofer®) and Natriumklorid 9 mg/ml, Fresenius Kabi in people with Non-anaemic Patients Undergoing Cardiac Surgery, run by Pharmacosmos A/S at 1 site in Denmark.
Trial summary
The purpose of the study is to demonstrate that intravenous iron isomaltoside 1000 (Monofer®) is superior compared to placebo with respect to increasing the haemoglobin level in non-anaemic patients undergoing cardiac surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-anaemic Patients Undergoing Cardiac Surgery
- What is being tested?
- Iron isomaltoside 1000 (Monofer®) and Natriumklorid 9 mg/ml, Fresenius Kabi
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2012to Sep 2013
- Phase
- Phase 3
- 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
- Men and women, aged more than 18 years.
- Subjects undergoing elective or sub-acute CABG, valve replacement or a combination thereof
- Female Hb ≥ 12.0 g/dl (7.45 mmol/l), Male Hb ≥ 13.0 g/dl (8.1 mmol/l).
- Willingness to participate after informed consent.
Who cannot join
- Subjects receiving blood transfusion less than 30 days before screening and/or during the elective or sub-acute CABG, valve replacement, or a combination thereof.
- Iron overload or disturbances in utilization of iron (e.g. haemochromatosis and haemosiderosis).
- Serum Ferritin > 800 ng/ml.
- Known hypersensitivity to any excipients in the investigational drug products.
- Patients with a history of multiple allergies.
- Decompensated liver cirrhosis and hepatitis.
Show all 15Show fewer
- Alanine Aminotransferase (ALT) > 3 times normal upper value.
- Acute infections (assessed by clinical judgement).
- Rheumatoid arthritis with symptoms or signs of active joint inflammation.
- Pregnant or nursing. (To avoid pregnancy, women have to be postmenopausal (at least 12 months must have elapsed since last menstruation), surgically sterile, or women of child bearing potential must use one of the following contraceptives during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product: Contraceptive pills, Intrauterine Devices (IUD), contraceptive depot injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches).
- Participation in any other clinical trial where the study drug has not passed five half-lives prior to screening.
- Untreated Vitamin B12 or folate deficiency.
- Other IV or oral iron treatment within 4 weeks prior to screening visit.
- Erythropoietin treatment within 4 weeks prior to screening visit
- Impaired renal function defined by se-creatinin > 150 µmol/l
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Prospective, Double-Blind, Comparative Placebo-Controlled Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by Infusions to Non-Anaemic Patients Undergoing Elective or Sub-Acute CABG, Valve Replacement or a Combination Thereof
The purpose of the study is to demonstrate that intravenous iron isomaltoside 1000 (Monofer®) is superior compared to placebo with respect to increasing the haemoglobin level in non-anaemic patients undergoing cardiac surgery
Read the detailed description
The role of preoperative haemoglobin as a predictor of short-term and long-term outcomes after cardiac surgery has been well established. Anaemia can impede a patient's ability to recover fully and participate in postoperative rehabilitation. It has been found that patients with a normal haemoglobin level may become anaemic during surgery. An evaluation of patients undergoing cardiac surgery, i.e. CABG, valve or combined CABG-valve procedures showed that there was a decrease in mean haemoglobin level pre-surgery two and four days after surgery. To date, no prospective randomised clinical study in cardiac surgery assessing the effect of intravenous iron supplementation in patients undergoing cardiac surgery has been reported. This prospective, randomized, placebo controlled, double blind study is planned to evaluate the effect of intravenous iron isomaltoside 1000 (Monofer®) in comparison with placebo in non-anaemic patients undergoing cardiac surgery.
- Being tested
- Iron isomaltoside 1000 (Monofer®), Natriumklorid 9 mg/ml, Fresenius Kabi
- Keywords
- Anaemia, Cardiac surgery
- Medical subject headings
- Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iron isomaltoside 1000 (Monofer®)Drug
All subjects randomised to this group will receive 1000 mg iron isomaltoside 1000 as a single dose infusion administered over 15 minutes
Natriumklorid 9 mg/ml, Fresenius KabiDrug
Also called 0.9% sodium chlorid.
All subjects randomised to this group will receive an infusion of 100 ml 0.9% sodium chlorid administered over 15 min.
| Study group | Role | What they receive |
|---|---|---|
| Iron isomaltoside 1000 (Monofer®) | Active comparator | Iron isomaltoside 1000 (Monofer®) - Intravenous Infusion Receives: Drug: Iron isomaltoside 1000 (Monofer®) |
| 0,9% sodium saline | Placebo comparator | Placebo (0.9% sodium saline) - Intravenous infusion Receives: Drug: Natriumklorid 9 mg/ml, Fresenius Kabi |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in haemoglobin (Hb) concentrations
To demonstrate that intravenous iron isomaltoside 1000 (Monofer®) is superior compared to placebo with respect to increasing the haemoglobin level in non- anaemic patients undergoing cardiac surgery
Measured: From t=0 to t=4 weeks postoperatively
Secondary outcomes (7)
Change in Hb concentrations
Proportion of patients that are anaemic (women < 12 g/dL and men < 13 g/dL) at day 5 and week 4
Measured: t=0, t=5 days and t=4 weeks
Number of patients in each randomisation group who need blood transfusion and number of transfusions administered
To compare the number of patients who will need blood transfusion and number of transfusions in each randomisation group
Measured: From t=0 to t=day 5 and t=4 weeks
Change in concentrations of serum ferritin, serum iron and Transferrin Saturation (TfS) TfS, and reticulocytes
From t=0 to t=day 5 and t=4 weeks
Measured: Change from baseline (preoperatively- the day before surgery or same day) in concentrations of serum ferritin, serum iron and Transferrin Saturation (TfS) TfS, and reticulocytes at 4 weeks and 3 months postoperatively
Number of postoperative days to discharge
To compare the number of days to discharge between the 2 randomisation groups
Measured: From t=0 to discharge
Changes in New York Heart Association (NYHA) classification
To compare the changes in New York Heart Association (NYHA) classification from baseline to 4 weeks postoperatively
Measured: From t=0 to t=4 weeks
Number of patients in each randomisation group who experience any study drug related adverse events (AEs/SAEs/SUSARs)
To compare the number of study drug related adverse events (AEs/SAEs/SUSARs) between subjects treated with iron isomaltoside 1000 (Monofer®) infusion and subjects treated with placebo infusion
Measured: From screening and until completion (t=-7 day and upto t=4 weeks)
Change in Hb
Proportion of patients able to maintain Hb between 9.5 and 12.5 g/dL (both values included) at day 5 and week 4
Measured: t=0, t=day 5 and t=week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionAug 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-anaemic Patients Undergoing 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pharmacosmos A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CRO Max Neeman
- Responsible party
- Sponsor
- Investigators
- Lars Lykke Thomsen, Study chair, Pharmacosmos A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01563367
- Sponsor's protocol ID
- P-Monofer-CABG-01
- Acronym
- CABG-01
- Status last verified
- Apr 2014
- First submitted
- 16 Mar 2012
- Last updated
- 29 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Prospective, Double-Blind, Comparative Placebo-Controlled Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by Infusions to Non-Anaemic Patients Undergoing Elective or Sub-Acute CABG, Valve Replacement or a Combination Thereof
- ClinicalTrials.gov ID
- NCT01563367
- Acronym / sponsor ID
- CABG-01 / P-Monofer-CABG-01
- Keywords
- Anaemia, Cardiac surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Pharmacosmos A/SIndustry (pharma, biotech, devices)
- Collaborators
- CRO Max Neeman
- Study start
- Jan 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 27 Mar 2012 (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 study is to demonstrate that intravenous iron isomaltoside 1000 (Monofer®) is superior compared to placebo with respect to increasing the haemoglobin level in non-anaemic patients undergoing cardiac surgery
Detailed description
The role of preoperative haemoglobin as a predictor of short-term and long-term outcomes after cardiac surgery has been well established. Anaemia can impede a patient's ability to recover fully and participate in postoperative rehabilitation. It has been found that patients with a normal haemoglobin level may become anaemic during surgery. An evaluation of patients undergoing cardiac surgery, i.e. CABG, valve or combined CABG-valve procedures showed that there was a decrease in mean haemoglobin level pre-surgery two and four days after surgery. To date, no prospective randomised clinical study in cardiac surgery assessing the effect of intravenous iron supplementation in patients undergoing cardiac surgery has been reported. This prospective, randomized, placebo controlled, double blind study is planned to evaluate the effect of intravenous iron isomaltoside 1000 (Monofer®) in comparison with placebo in non-anaemic patients undergoing cardiac surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iron isomaltoside 1000 (Monofer®) | Active comparator | Drug: Iron isomaltoside 1000 (Monofer®)Iron isomaltoside 1000 (Monofer®) - Intravenous Infusion |
| 0,9% sodium saline | Placebo comparator | Drug: Natriumklorid 9 mg/ml, Fresenius KabiPlacebo (0.9% sodium saline) - Intravenous infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Men and women, aged more than 18 years.
- Subjects undergoing elective or sub-acute CABG, valve replacement or a combination thereof
- Female Hb ≥ 12.0 g/dl (7.45 mmol/l), Male Hb ≥ 13.0 g/dl (8.1 mmol/l).
- Willingness to participate after informed consent.
Key exclusion criteria (15 listed)
- Subjects receiving blood transfusion less than 30 days before screening and/or during the elective or sub-acute CABG, valve replacement, or a combination thereof.
- Iron overload or disturbances in utilization of iron (e.g. haemochromatosis and haemosiderosis).
- Serum Ferritin > 800 ng/ml.
- Known hypersensitivity to any excipients in the investigational drug products.
- Patients with a history of multiple allergies.
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 |
|---|---|---|
| Iron isomaltoside 1000 (Monofer®)All subjects randomised to this group will receive 1000 mg iron isomaltoside 1000 as a single dose infusion administered over 15 minutes | Drug | Iron isomaltoside 1000 (Monofer®) |
| Natriumklorid 9 mg/ml, Fresenius KabiAlso: 0.9% sodium chlorid.All subjects randomised to this group will receive an infusion of 100 ml 0.9% sodium chlorid administered over 15 min. | Drug | 0,9% sodium saline |
Primary outcome
Change in haemoglobin (Hb) concentrations
Time frame: From t=0 to t=4 weeks postoperatively
To demonstrate that intravenous iron isomaltoside 1000 (Monofer®) is superior compared to placebo with respect to increasing the haemoglobin level in non- anaemic patients undergoing cardiac surgery
7 secondary outcomes
Change in Hb concentrations
Time frame: t=0, t=5 days and t=4 weeks
Number of patients in each randomisation group who need blood transfusion and number of transfusions administered
Time frame: From t=0 to t=day 5 and t=4 weeks
Change in concentrations of serum ferritin, serum iron and Transferrin Saturation (TfS) TfS, and reticulocytes
Time frame: Change from baseline (preoperatively- the day before surgery or same day) in concentrations of serum ferritin, serum iron and Transferrin Saturation (TfS) TfS, and reticulocytes at 4 weeks and 3 months postoperatively
Number of postoperative days to discharge
Time frame: From t=0 to discharge
Changes in New York Heart Association (NYHA) classification
Time frame: From t=0 to t=4 weeks
Number of patients in each randomisation group who experience any study drug related adverse events (AEs/SAEs/SUSARs)
Time frame: From screening and until completion (t=-7 day and upto t=4 weeks)
Change in Hb
Time frame: t=0, t=day 5 and t=week 4
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 29 Apr 2014.
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.
Lars Lykke Thomsen study chair
Pharmacosmos 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 3 study testing Iron isomaltoside 1000 (Monofer®) and Natriumklorid 9 mg/ml, Fresenius Kabi in people with Non-anaemic Patients Undergoing Cardiac Surgery, run by Pharmacosmos 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 4 inclusion and 15 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 29 Apr 2014. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change in haemoglobin (Hb) concentrations (time frame: From t=0 to t=4 weeks postoperatively). 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 29 Apr 2014.