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

Pharmacosmos

Status and phase: Completed; Phase 3

Conditions: Iron-deficiency

Treatments: Drug: Iron isomaltoside 1000 (Monofer®); Drug: Placebo

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT01895231

P-Monofer-BD-02

Details and patient eligibility

About

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

Full 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.

Enrollment: 107 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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107 participants in 2 patient groups, including a placebo group

Iron isomaltoside 1000

Experimental group

Description:

Monofer® 1000 mg IV infusion over 15 minutes

Treatment:

Drug: Iron isomaltoside 1000 (Monofer®)

Placebo

Placebo Comparator group

Description:

0.9 % saline Infusion over 15 min

Treatment:

Drug: Placebo