Iron Isomaltoside and Iron Sucrose for the Treatment of Iron Deficiency Anemia (IDA)

IDA is highly prevalent in subjects with cancer and gastrointestinal diseases such as
inflammatory bowel diseases, 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 treatment of these subjects includes controlling the bleeding and
replenishing lost iron.

This study is designed to evaluate the safety and efficacy of iron isomaltoside compared to
iron sucrose in subjects suffering from IDA. In a subfraction of 35 subjects treated with
iron isomaltoside ECG and iron will be measured frequently

Inclusion criteria includes:

1. Men or women ≥ 18 years

2. Subjects having IDA caused by different etiologies

3. Subjects with intolerance to oral iron therapy or a need for rapid repletion of iron
stores:

4. Hb ≤ 11 g/dL

5. TSAT < 20 %

6. S-ferritin < 100 ng/mL

7. Willingness to participate and signing the informed consent form

Exclusion Criteria includes :

1. Anemia predominantly caused by factors other than IDA

2. Hemochromatosis or other iron storage disorders

3. Previous serious hypersensitivity reactions to any IV iron compound

4. Erythropoiesis stimulating agent (ESA) treatment

5. Prior to screening or during the trial period; has or will be treated with a red blood
cell transfusion, radiotherapy, and/or chemotherapy

6. Will require a surgical procedure that necessitated general anesthesia prior to
screening or during the trial period

7. Alanine aminotransferase and/or aspartate aminotransferase > 3 times upper limit of
normal

8. Required dialysis for treatment of CKD

9. Alcohol or drug abuse within the past 6 months

10. Pregnant or nursing women