A Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by Infusions to Iron-deficient Blood Donors

March 14, 2018 updated by: Pharmacosmos A/S

A Randomized, Prospective, Double-Blind, Comparative Placebo-Controlled Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by Infusions to Iron-Deficient Blood Donors

The primary purpose of the study is to evaluate the effect of IV iron isomaltoside 1000 compared with placebo on Hb in first-time female donors with p-ferritin below 30 µg/L

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

At present, clinical efficacy and safety data is available for iron isomaltoside 1000 administered to patients with IDA requiring iron therapy. However, there is a need for clinical efficacy and safety data within iron deficiency without anaemia which is e.g. observed in blood donors. Thus, this study is planned to compare the efficacy and safety of parenteral iron isomaltoside 1000 with placebo in female blood donors with a p-ferritin below 30 µg/L.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
107

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Women aged ≥ 18 years
  2. First-time donor
  3. P-ferritin < 30 µg/L
  4. Willingness to participate and signed the informed consent form

Exclusion Criteria:

  1. Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
  2. Known hypersensitivity to any excipients in the investigational drug products
  3. History of drug related allergies
  4. History of severe asthma
  5. Decompensated liver cirrhosis and hepatitis (defined as ALAT > 3 times upper limit of normal)
  6. Active acute or chronic infections (assessed by clinical judgement supplied with White Blood Cells (WBC) and C-Reactive Protein (CRP))
  7. Rheumatoid arthritis with symptoms or signs of active inflammation
  8. Subjects who are pregnant or nursing. In order to avoid pregnancy, women have to be postmenopausal (at least 12 months since last menstruation), surgically sterile, or 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: intrauterine devices and hormonal contraceptives (contraceptive pills, implants, transdermal patches, vaginal devices, or hormonal injections with prolonged release)
  9. Participation in any other clinical study where the study drug has not passed 5 half-lives prior to the screening
  10. Untreated vitamin B12 or folate deficiency
  11. Treated with other IV or oral iron products within 4 weeks prior to the screening
  12. Treated with Erythropoietin (EPO) within 4 weeks prior to the screening
  13. Any other medical condition that, in the opinion of the Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Iron isomaltoside 1000
Monofer® 1000 mg IV infusion over 15 minutes
Drug: Iron isomaltoside 1000 (Monofer®)
Other Names:
  • Monofer®
Placebo Comparator: Placebo
0.9 % saline Infusion over 15 min
Drug: Placebo
Other Names:
  • 0.9 % saline

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Hb concentration
Time Frame: From baseline and until t= 6 months
The primary endpoint is to measure and compare the change in Hb concentration from baseline to right before the third blood donation in the two study arms
From baseline and until t= 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Hb concentration
Time Frame: From baseline and until t=3 months
Change in Hb concentrations from baseline to right before second donation
From baseline and until t=3 months
Ability to complete 3 blood donations
Time Frame: From baseline and until t=6 months
Number of subjects who cannot complete three donations due to low Hb
From baseline and until t=6 months
Change in p-iron
Time Frame: From baseline and until week 12
From baseline and until week 12
Change in fatigue symptoms
Time Frame: From baseline and until week 12
From baseline and until week 12
Exercise tolerance
Time Frame: From baseline to week 3
Change in exercise tolerance from baseline to 3 weeks after baseline measured by a two-step test on bike
From baseline to week 3
Number of adverse drug reactions
Time Frame: From screening and until t= 6 months
From screening and until t= 6 months
Change in p-ferritin
Time Frame: From baseline and until week 12
From baseline and until week 12
Change in Transferrin Saturation (TSAT)
Time Frame: From baseline until week 12
From baseline until week 12
Change in reticulocyte count
Time Frame: From Baseline to week 12
From Baseline to week 12
Change in haematology parameters
Time Frame: From baseline and until t= 6 months
From baseline and until t= 6 months
Change in RLS symptoms
Time Frame: From baseline and until t= 6 months
From baseline and until t= 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pharmacosmos A/S

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Max Neeman

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nørgaard, RH Blodbanken

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 4, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 14, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P-Monofer-BD-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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