IDA-01 A Randomised, Open-Label, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) and Iron Sucrose
Condition: Iron Deficiency Anaemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Intervention: iron isomaltoside 1000 (Monofer®); iron sucrose (Venofer®)
Intervention MeSH terms: Iron; Ferric Oxide, Saccharated; Iron isomaltoside 1000
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 511.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: IDA; Iron deficiency; iron deficiency anaemia and who are intolerant or unresponsive to oral iron therapy

Summary:

      The purpose of the trial is to evaluate and compare the effect of iron isomaltoside 1000 to
      iron sucrose in its ability to increase haemoglobin (Hb) in subjects with IDA when oral iron
      preparations are ineffective or cannot be used or where there is a clinical need to deliver
      iron rapidly.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men or women > 18 years having IDA caused by different aetiologies such as abnormal
             uterine bleeding, gastrointestinal diseases, cancer, bariatric procedures (gastric
             bypass operations), and other conditions leading to significant blood loss and with a
             documented history of intolerance or unresponsiveness to oral iron therapy for at
             least one month prior to study enrollment or where there at investigators judgment is
             a clinical need to deliver iron rapidly

          2. Hb < 11 g/dL

          3. TSAT < 20 %

          4. S-ferritin < 100 ng/mL

          5. Willingness to participate and signing the informed consent form

        Exclusion Criteria:

          1. Anaemia predominantly caused by factors other than IDA (e.g. anaemia with untreated
             vitamin B12 or folate deficiency, haemolytic anaemia)

          2. Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and
             haemosiderosis)

          3. Decompensated liver cirrhosis or active hepatitis (ALAT > 3 times upper limit of
             normal)

          4. Active acute or chronic infections (assessed by clinical judgement supplied with white
             blood cells (WBC) and C-reactive protein (CRP))

          5. Body weight < 50 kg

          6. Rheumatoid arthritis with symptoms or signs of active inflammation

          7. Pregnant or nursing women. In order to avoid pregnancy, women have to be surgically
             sterile or use adequate contraception (e.g. intrauterine devices, hormonal
             contraceptives, or double barrier method) during the whole study period and after the
             study has ended for at least 5 times plasma biological half-life of the
             investigational medicinal product

          8. History of multiple allergies

          9. Known hypersensitivity to parenteral iron or any excipients in the investigational
             drug products

         10. Erythropoietin treatment within 8 weeks prior to the screening visit

         11. Other iron treatment or blood transfusion within 4 weeks prior to the screening visit

         12. Planned elective surgery during the study

         13. Participation in any other clinical study within 3 months prior to the screening

         14. Any other medical condition that, in the opinion of Investigator, may cause the
             subject to be unsuitable for the completion of the study or place the subject at
             potential risk from being in the study, e.g. uncontrolled hypertension, unstable
             ischaemic heart disease, or uncontrolled diabetes mellitus