A Randomized, Double-blind, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Against Placebo

IDA is highly prevalent in subjects and can have a substantial medical and quality of life
(QoL) burden on the subjects and the treatment of these subjects includes replenishing lost
iron. Oral iron administration is often used in the clinical practice at many clinics;
however, oral iron may not be tolerated by all subjects. Hence, there is a need for an
alternative iron treatment in subjects, who do not tolerate oral iron.

This study is planned to compare the efficacy and safety of iron isomaltoside 1000 with
placebo in subjects with IDA and who are intolerant or unresponsive to oral iron therapy..

Inclusion Criteria:

1. Men or women ≥ 18 years having IDA caused by different aetiologies* such as ab-normal
uterine bleeding, gastrointestinal diseases (e.g. inflammatory bowel disease),
cancer, preoperative anaemia (e.g. orthopaedic surgery), and other conditions leading
to IDA and with a documented history of intolerance or unresponsiveness to oral iron
therapy** for at least one month*** prior to study enrolment

2. Hb < 11 g/dL

3. TSAT < 20 %

4. S-ferritin < 100 ng/mL

5. Willingness to participate and signing the informed consent form (ICF)

Exclusion Criteria:

1. Hb < 6 g/dL

2. Anaemia predominantly caused by factors other than IDA (e.g. anaemia with untreat-ed
vitamin B12 or folate deficiency, haemolytic anaemia)

3. Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and
hae-mosiderosis)

4. Decompensated liver cirrhosis or active hepatitis (ALAT > 3 times upper limit of
normal)

5. Active acute or chronic infections (assessed by clinical judgement supplied with
white blood cells (WBC) and C-reactive protein (CRP))

6. Body weight < 50 kg

7. Pregnant or nursing women. In order to avoid pregnancy, women of childbearing
po-tential have to use adequate contraception (e.g. intrauterine devices, hormonal
contra-ceptives, or double barrier method) during the whole study period and 7 days
after the last dosing

8. History of multiple allergies

9. Known hypersensitivity to parenteral iron or any excipients in the investigational
drug products

10. Erythropoietin treatment within 8 weeks prior to the screening visit

11. Other intravenous (IV) iron treatment or blood transfusion within 4 weeks prior to
the screening visit

12. Participation in any other interventional clinical study within 3 months prior to the
screening

13. Any other medical condition that, in the opinion of 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, e.g. uncontrolled hypertension, unstable
ischemic heart disease, or uncontrolled diabetes mellitus