An Extension Trial to Assess the Safety of Re-dosing of Iron Isomaltoside (Monofer®)

Among the various formulations of parenteral iron available on the market, iron isomaltoside
may allow flexibility in terms of high and rapid dosing. The use of parenteral iron,
especially in high doses, may result in better compliance, fewer visits to the medical
practitioner, and overall improvement in QoL.

Most trials with IV iron have been 4-12 weeks trials and long-term trials are warranted to
fol-low-up on long-term safety.

This trial is a 6-months extension trial where the aim is to evaluate the safety and efficacy
of IV iron isomaltoside re-dosing.

Inclusion Criteria:

1. Completed one of the lead-in trials

2. Randomised and dosed with iron isomaltoside in one of the lead-in trials.

3. Hb of ≤ 11 g/dL

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

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

Exclusion Criteria:

1. IV iron treatment between the lead-in trial and screening

2. During 30-day period prior to screening or during the trial period; has or will be
treated with a red blood cell transfusion, radiotherapy, and/or chemotherapy

3. Received an investigational drug within 30 days of screening

4. Decompensated liver cirrhosis or active hepatitis

5. Pregnant or nursing women.

6. Any other laboratory abnormality, medical condition, or psychiatric disorders which,
in the opinion of the Investigator, will put the subject's disease management at risk
or may result in the subject being unable to comply with the trial requirements