A Prospective, Comparative Study of Intravenous Iron Isom... | NCT01563367

Studies
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

Sponsor

Pharmacosmos A/S

Status

Completed

Last Update Posted

Apr 29, 2014Estimated

Enrollment

74Actual

Phase

Phase 3

Conditions

Non-anaemic Patients Undergoing Cardiac Surgery

Interventions

Iron isomaltoside 1000 (Monofer®)
Natriumklorid 9 mg/ml, Fresenius Kabi

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Apr 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Aug 2013Actual

Completion Date

Sep 2013Actual

First Submitted Date

Mar 16, 2012

First Submission Date that Met QC Criteria

Mar 22, 2012

First Posted Date

Mar 27, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2014

Last Update Posted Date

Apr 29, 2014Estimated

Name	Class
CRO Max Neeman	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

74Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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®)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases