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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Iron-deficiency

Intervention / Treatment
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* Drug: Iron isomaltoside 1000 (Monofer®)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged ≥ 18 years First-time donor P-ferritin < 30 µg/L Willingness to participate and signed the informed consent form Exclusion Criteria: Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis) Known hypersensitivity to any excipients in the investigational drug products History of drug related allergies History of severe asthma Decompensated liver cirrhosis and hepatitis (defined as ALAT > 3 times upper limit of normal) Active acute or chronic infections (assessed by clinical judgement supplied with White Blood Cells (WBC) and C-Reactive Protein (CRP)) Rheumatoid arthritis with symptoms or signs of active inflammation 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) Participation in any other clinical study where the study drug has not passed 5 half-lives prior to the screening Untreated vitamin B12 or folate deficiency Treated with other IV or oral iron products within 4 weeks prior to the screening Treated with Erythropoietin (EPO) within 4 weeks prior to the screening 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iron isomaltoside 1000<br>Monofer® 1000 mg IV infusion over 15 minutes | Drug: Iron isomaltoside 1000 (Monofer®)<br> <br> * Other names: Monofer®;|
| Placebo Comparator: Placebo<br>0.9 % saline Infusion over 15 min | Drug: Placebo<br> <br> * Other names: 0.9 % saline;|

What is the study measuring?
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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 |