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

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: Completed
• Conditions: Iron-deficiency
• Intervention / Treatment: Drug: Placebo; Drug: Iron isomaltoside 1000 (Monofer®)

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: Interventional
• Enrollment (Actual): 107
• Phase: Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change in Hb concentration	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

Outcome Measure	Measure Description	Time Frame
Change in Hb concentration	Change in Hb concentrations from baseline to right before second donation	From baseline and until t=3 months
Ability to complete 3 blood donations	Number of subjects who cannot complete three donations due to low Hb	From baseline and until t=6 months
Change in p-iron		From baseline and until week 12
Change in fatigue symptoms		From baseline and until week 12
Exercise tolerance	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		From screening and until t= 6 months
Change in p-ferritin		From baseline and until week 12
Change in Transferrin Saturation (TSAT)		From baseline until week 12
Change in reticulocyte count		From Baseline to week 12
Change in haematology parameters		From baseline and until t= 6 months
Change in RLS symptoms		From baseline and until t= 6 months

Collaborators and Investigators

• Sponsor: Pharmacosmos A/S
• Collaborators: Max Neeman
• Investigators: Principal Investigator: Nørgaard, RH Blodbanken

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: June 26, 2013
• First Submitted That Met QC Criteria: July 4, 2013
• First Posted (Estimate): July 10, 2013

Study Record Updates

• Last Update Posted (Actual): March 15, 2018
• Last Update Submitted That Met QC Criteria: March 14, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Anemia, Iron-Deficiency; Hematinics; Iron isomaltoside 1000
• Other Study ID Numbers: P-Monofer-BD-02