IDA-01 A Randomised, Open-Label, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) and Iron Sucrose

IDA is highly prevalent in subjects with gastrointestinal diseases and cancer, menstruating
or pregnant women, and subjects who have undergone bariatric procedure. IDA can have a
substantial medical and quality of life (QoL) burden on the subjects and the treatment of
these subjects includes controlling the bleeding and 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
another parenteral iron preparation (iron sucrose) in subjects with IDA and who are
intolerant or unresponsive to oral iron therapy or who need iron rapidly.

Inclusion Criteria:

1. Men or women > 18 years having IDA caused by different aetiologies such as abnormal
uterine bleeding, gastrointestinal diseases, cancer, bariatric procedures (gastric
bypass operations), and other conditions leading to significant blood loss and with a
documented history of intolerance or unresponsiveness to oral iron therapy for at
least one month prior to study enrollment or where there at investigators judgment is
a clinical need to deliver iron rapidly

2. Hb < 11 g/dL

3. TSAT < 20 %

4. S-ferritin < 100 ng/mL

5. Willingness to participate and signing the informed consent form

Exclusion Criteria:

1. Anaemia predominantly caused by factors other than IDA (e.g. anaemia with untreated
vitamin B12 or folate deficiency, haemolytic anaemia)

2. Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and
haemosiderosis)

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

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

5. Body weight < 50 kg

6. Rheumatoid arthritis with symptoms or signs of active inflammation

7. Pregnant or nursing women. In order to avoid pregnancy, women have to be surgically
sterile or use adequate contraception (e.g. intrauterine devices, hormonal
contraceptives, or double barrier method) 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

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 iron treatment or blood transfusion within 4 weeks prior to the screening visit

12. Planned elective surgery during the study

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

14. 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
ischaemic heart disease, or uncontrolled diabetes mellitus