Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose or Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia
Condition: Iron Deficiency Anaemia; Iron Deficiency Anemia
MeSH terms: Anemia; Anemia, Iron-Deficiency; Iron Deficiencies; Deficiency Diseases; Hypophosphatemia
Intervention: Iron isomaltoside/ferric derisomaltose; Ferric carboxymaltose
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 a single IV infusion of 1000 mg (10 mL containing 1000 mg iron isomaltoside/ferric derisomaltose diluted in 100 mL 0.9 % sodium chloride), given over approximately 20 minutes (50 mg iron/min) at baseline (cumulative dose: 1000 mg).; Ferric carboxymaltose (Injectafer®; 50 mg/mL) was the comparator in this trial. The dose of ferric carboxymaltose for the individual subject was 750 mg, infused over at least 15 minutes at baseline and on day 7 (cumulative dose: 1500 mg).
Intervention MeSH terms: Iron isomaltoside 1000
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 122.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Iron Deficiency Anaemia; Iron Deficiency Anemia; IDA; Iron deficiency; Intravenous iron replacement therapy; Iron isomaltoside; Ferric derisomaltose; Hypophosphatemia; Ferric carboxymaltose; Monofer; Monoferric; Monover; Monofar; Monoferro

Summary:

      The trial was designed to evaluate the incidence of unintended hypophosphatemia (low level of
      phosphate in the blood) in subjects with iron deficiency anaemia (IDA).
    

Eligibility criteria:

        Inclusion criteria include:

          -  Subjects having IDA caused by different aetiologies

          -  Haemoglobin (Hb) ≤ 11 g/dL

          -  Body weight > 50 kg

          -  Serum ferritin (S-ferritin) < 100 ng/mL

          -  Estimated Glomerular Filtration Rate (eGFR) ≥ 65 mL/min/1.73 m2

          -  Serum phosphate (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.