A Trial Comparing the Incidence of Hypophosphatemia in Relation to Treatment With Iron Isomaltoside and Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia (IDA-04)

Existing IV iron complexes differ in relation to the compounds capability to induce
unintended hypophosphatemia to a degree defined as medical significant.

This trial is designed evaluate the effect of IV iron isomaltoside compared to IV ferric
carboxymaltose on phosphate in subjects with IDA.

Inclusion Criteria include:

- subjects having IDA caused by different aetiologies

- Hb ≤ 11 g/dL

- Body weight > 50 kg

- S-ferritin < 100 ng/mL

- eGFR ≥ 65 mL/min/1.73 m2

- S-phosphate > 2.5 mg/dL

- intolerance or unresponsiveness to oral iron

- Willingness to participate and signing the Informed Consent Form (ICF)

Exclusion Criteria include:

- Acute bleeding > 500 mL within 72 hours

- Anaemia predominantly caused by factors other than IDA

- Hemochromatosis or other iron storage disorders

- Previous serious hypersensitivity reactions to any IV iron compounds

- Treatment with IV iron within the last 30 days prior to screening

- Treatment with erythropoietin or erythropoietin-stimulation agents

- Red blood cell transfusion, radiotherapy, and/or chemotherapy

- Received an investigational drug within the last 30 days prior to screening

- Planned surgical procedure within the trial period

- hepatic enzymes > 3 times upper limit of normal

- Surgery under anaesthetic within the last 30 days prior to screening

- Any non-viral infection within the last 30 days prior to screening

- Alcohol or drug abuse within the past 6 months

- Vitamin D deficiency

- Untreated hyperparathyroidism

- Kidney transplantation

- Active malignant disease, disease-free for less than 5 years

- History of a psychological illness or seizures

- Pregnant or nursing women.