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

NCT01563367 | Completed Phase 3 DMC

• 1 other identifier: P-Monofer-CABG-01
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Non-anaemic Patients Undergoing Cardiac Surgery

Keywords

Anaemia; Cardiac surgery

Outcome Measures

Primary Outcomes (1)

• 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

  From t=0 to t=4 weeks postoperatively

Secondary Outcomes (7)

• Change in Hb concentrations

  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

  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

  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

  From t=0 to discharge

• Changes in New York Heart Association (NYHA) classification

  From t=0 to t=4 weeks

Study Arms (2)

Iron isomaltoside 1000 (Monofer®)

ACTIVE COMPARATOR

Iron isomaltoside 1000 (Monofer®) - Intravenous Infusion

Drug: Iron isomaltoside 1000 (Monofer®)

0,9% sodium saline

PLACEBO COMPARATOR

Placebo (0.9% sodium saline) - Intravenous infusion

Drug: Natriumklorid 9 mg/ml, Fresenius Kabi

Interventions

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

Iron isomaltoside 1000 (Monofer®)

Natriumklorid 9 mg/ml, Fresenius Kabi DRUG

All subjects randomised to this group will receive an infusion of 100 ml 0.9% sodium chlorid administered over 15 min.

Also known as: 0.9% sodium chlorid.

0,9% sodium saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Pharmacosmos A/S: lead
• CRO Max Neeman: collaborator

Study Sites (1)

Unknown Facility

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Anemia

Interventions

iron isomaltoside 1000

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Lars Lykke Thomsen

  Pharmacosmos A/S

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2012
• First Posted: March 27, 2012
• Study Start: January 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: September 1, 2013
• Last Updated: April 29, 2014

Record last verified: 2014-04

Locations

DK (1)