Iron Isomaltoside/Ferric Derisomaltose vs Iron Sucrose for the Treatment of Iron Deficiency Anemia (IDA)
Condition: Iron Deficiency Anaemia; Iron Deficiency Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases
Intervention: Iron isomaltoside/ferric derisomaltose; Iron sucrose
Intervention description: Iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) was the test product in this trial.
The dose of iron isomaltoside/ferric derisomaltose for the individual subject was set to 1000 mg. The dose was diluted in 100 mL 0.9 % sodium chloride (100 mL bags) and administered as a single IV infusion over approximately 20 minutes.; Iron sucrose (Venofer®; 20 mg elemental iron/mL) was the comparator in this trial.
Iron sucrose was administered as 200 mg undiluted IV injections over approximately 2-5 minutes and repeated according to standard practice or physician choice up to a maximum of five times within the first two weeks starting at baseline. A cumulative dose of 1000 mg was recommended.
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: 1512.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Iron Deficiency Anaemia; Iron Deficiency Anemia; IDA; Intravenous iron replacement therapy; Iron isomaltoside; Ferric derisomaltose; Monofer; Monoferric; Monover; Monofar; Monoferro

Summary:

      Evaluate safety and efficacy of iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®)
      compared with iron sucrose (Venofer®), in subjects diagnosed with IDA.
    

Eligibility criteria:

        Inclusion criteria includes:

          1. Men or women ≥ 18 years

          2. Subjects having IDA caused by different etiologies

          3. Subjects with intolerance to oral iron therapy or a need for rapid repletion of iron
             stores:

          4. Haemoglobin (Hb) ≤ 11 g/dL

          5. Transferrin Saturation (TSAT) < 20 %

          6. S-ferritin < 100 ng/mL

          7. Willingness to participate and signing the informed consent form

        Exclusion Criteria includes :

          1. Anemia predominantly caused by factors other than IDA

          2. Hemochromatosis or other iron storage disorders

          3. Previous serious hypersensitivity reactions to any IV iron compound

          4. Erythropoiesis stimulating agent (ESA) treatment

          5. Prior to screening or during the trial period; has or will be treated with a red blood
             cell transfusion, radiotherapy, and/or chemotherapy

          6. Will require a surgical procedure that necessitated general anesthesia prior to
             screening or during the trial period

          7. Alanine aminotransferase and/or aspartate aminotransferase > 3 times upper limit of
             normal

          8. Required dialysis for treatment of chronic kidney disease (CKD)

          9. Alcohol or drug abuse within the past 6 months

         10. Pregnant or nursing women