Iron Isomaltoside and Iron Sucrose for the Treatment of Iron Deficiency Anemia in Non-Dialysis-Dependent Chronic Kidney Disease

Iron deficiency anaemia (IDA) is a common problem associated with many chronic diseases such
as chronic kidney disease (CKD). IDA can have a substantial medical and quality of life (QoL)
burden on the subjects, and treatment of these subjects includes treatment of its underlying
cause and restoration of haemoglobin (Hb) concentrations and iron stores.

This study is planned to evaluate the safety and efficacy of iron isomaltoside compared to
iron sucrose in subjects with IDA and NDD-CKD.

Inclusion Criteria includes:

1. Men or women ≥ 18 years

2. Hb ≤ 11 g/dL

3. Chronic renal impairment, as defined by either (i) eGFR < 60 mL/min/1.73m2 at
screening (as calculated by modification of diet in renal disease (MDRD)), or (ii)
eGFR < 90 mL/min/1.73m2 at screening and kidney damage as indicated by abnormalities
in urine composition per medical history and/or intermediate/high risk of
cardio-vascular disease based on the Framingham model

4. Screening s-ferritin ≤ 100 ng/mL, or ≤ 300 ng/mL if TSAT ≤ 30 %

5. Either no ESAs or ESAs as a stable dose 4 weeks before randomisation

6. Willingness to participate and signing the informed consent form

Exclusion Criteria includes:

1. Anaemia predominantly caused by factors other than IDA

2. Hemochromatosis or other iron storage disorders

3. Previous serious hypersensitivity reactions to any IV iron compounds

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

5. Undergoing dialysis for treatment of CKD

6. Planned surgical procedure within the trial period

7. Decompensated liver cirrhosis or active hepatitis

8. Alcohol or drug abuse within the past 6 month.

9. Pregnant or nursing women.