Dose-escalation Trial of the Safety, Pharmacokinetics, and Pharmacodynamics of Iron Isomaltoside (Monofer®)

Exclusion Criteria

• •1. Anemia caused by conditions other than iron deficiency
• •2. Cancer
• •3. IV or oral iron treatment, or blood transfusion 4 weeks prior to screening
• •4. Erythropoiesis stimulating agent (ESA) treatment prior to screening
• •5. Imminent expectation of blood transfusion on part of treating physician
• •6. Iron overload or disturbances (e.g. hemochromatosis and hemo-siderosis)
• •7. Known hypersensitivity reaction to iv iron preparations
• •8. Decompensated liver cirrhosis or active hepatitis
• •9. Active acute or chronic infections
• •10. Pregnant or nursing women.
• •11. Planned elective surgery during the trial