Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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 (CABG-01)

This study has been completed.
Sponsor:
Collaborator:
CRO Max Neeman
Information provided by (Responsible Party):
Pharmacosmos A/S
ClinicalTrials.gov Identifier:
NCT01563367
First received: March 16, 2012
Last updated: April 28, 2014
Last verified: April 2014

March 16, 2012
April 28, 2014
January 2012
August 2013   (final data collection date for primary outcome measure)
Change in haemoglobin (Hb) concentrations [ Time Frame: From t=0 to t=4 weeks postoperatively ] [ Designated as safety issue: No ]
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
Change in haemoglobin (Hb) concentrations [ Time Frame: From t=0 to t=4 weeks postoperatively ] [ Designated as safety issue: No ]
To demonstrate that intravenous iron isomaltoside 1000 (Monofer®) is superior compared to placebo with respect to increasing the haemoglobin level in preoperative anaemic patients undergoing cardiac surgery
Complete list of historical versions of study NCT01563367 on ClinicalTrials.gov Archive Site
  • Change in Hb concentrations [ Time Frame: t=0, t=5 days and t=4 weeks ] [ Designated as safety issue: No ]
    Proportion of patients that are anaemic (women < 12 g/dL and men < 13 g/dL) at day 5 and week 4
  • 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 ] [ Designated as safety issue: No ]
    To compare the number of patients who will need blood transfusion and number of transfusions in each randomisation group
  • 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 ] [ Designated as safety issue: No ]
    From t=0 to t=day 5 and t=4 weeks
  • Number of postoperative days to discharge [ Time Frame: From t=0 to discharge ] [ Designated as safety issue: No ]
    To compare the number of days to discharge between the 2 randomisation groups
  • Changes in New York Heart Association (NYHA) classification [ Time Frame: From t=0 to t=4 weeks ] [ Designated as safety issue: No ]
    To compare the changes in New York Heart Association (NYHA) classification from baseline to 4 weeks postoperatively
  • 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) ] [ Designated as safety issue: Yes ]
    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
  • Change in Hb [ Time Frame: t=0, t=day 5 and t=week 4 ] [ Designated as safety issue: No ]
    Proportion of patients able to maintain Hb between 9.5 and 12.5 g/dL (both values included) at day 5 and week 4
  • Change in Hb concentrations [ Time Frame: From t=0 to to t=3 months postoperatively ] [ Designated as safety issue: No ]
    To compare the change in Hb concentrations from baseline to 3 months postoperatively
  • Number of patients in each randomisation group who need blood transfusion and number of transfusions administered [ Time Frame: From t=0 to t=4 weeks and t=3 months ] [ Designated as safety issue: No ]
    To compare the number of patients who will need blood transfusion and number of transfusions in each randomisation group
  • 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 ] [ Designated as safety issue: No ]
    From t=0 to t=4 weeks and t=3 months postoperatively
  • Number of postoperative days to discharge [ Time Frame: From t=0 to discharge ] [ Designated as safety issue: No ]
    To compare the number of days to discharge between the 2 randomisation groups
  • Changes in six-minute walking distance [ Time Frame: From t=0 to t=4 weeks ] [ Designated as safety issue: No ]
    To compare the changes in six-minute walking distance from baseline to 4 weeks post operatively between the 2 groups
  • Number of patients in each randomisation group who experience any study drug related adverse events (AEs/SAEs/SUSARs) [ Time Frame: t= -7 days ] [ Designated as safety issue: Yes ]
    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
Not Provided
Not Provided
 
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 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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Non-anaemic Patients Undergoing Cardiac Surgery
  • Drug: 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
    Other Name: Iron isomaltoside 1000 (Monofer®)
  • Drug: Natriumklorid 9 mg/ml, Fresenius Kabi
    All subjects randomised to this group will receive an infusion of 100 ml 0.9% sodium chlorid administered over 15 min.
    Other Names:
    • Natriumklorid 9 mg/ml, Fresenius Kabi
    • 0.9% sodium chlorid.
  • Active Comparator: Iron isomaltoside 1000 (Monofer®)
    Iron isomaltoside 1000 (Monofer®) - Intravenous Infusion
    Intervention: Drug: Iron isomaltoside 1000 (Monofer®)
  • Placebo Comparator: 0,9% sodium saline
    Placebo (0.9% sodium saline) - Intravenous infusion
    Intervention: Drug: Natriumklorid 9 mg/ml, Fresenius Kabi
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
74
September 2013
August 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Men and women, aged more than 18 years.
  2. Subjects undergoing elective or sub-acute CABG, valve replacement or a combination thereof
  3. Female Hb ≥ 12.0 g/dl (7.45 mmol/l), Male Hb ≥ 13.0 g/dl (8.1 mmol/l).
  4. Willingness to participate after informed consent.

Exclusion Criteria:

  1. 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.
  2. Iron overload or disturbances in utilization of iron (e.g. haemochromatosis and haemosiderosis).
  3. Serum Ferritin > 800 ng/ml.
  4. Known hypersensitivity to any excipients in the investigational drug products.
  5. Patients with a history of multiple allergies.
  6. Decompensated liver cirrhosis and hepatitis.
  7. Alanine Aminotransferase (ALT) > 3 times normal upper value.
  8. Acute infections (assessed by clinical judgement).
  9. Rheumatoid arthritis with symptoms or signs of active joint inflammation.
  10. 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).
  11. Participation in any other clinical trial where the study drug has not passed five half-lives prior to screening.
  12. Untreated Vitamin B12 or folate deficiency.
  13. Other IV or oral iron treatment within 4 weeks prior to screening visit.
  14. Erythropoietin treatment within 4 weeks prior to screening visit
  15. Impaired renal function defined by se-creatinin > 150 µmol/l
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01563367
P-Monofer-CABG-01
Yes
Pharmacosmos A/S
Pharmacosmos A/S
CRO Max Neeman
Study Chair: Lars Lykke Thomsen Pharmacosmos A/S
Pharmacosmos A/S
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP