Overview
Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose or Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia
Status:
Completed
Completed
Trial end date:
2018-05-29
2018-05-29
Target enrollment:
0
0
Participant gender:
All
All
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).Phase:
Phase 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Pharmacosmos A/STreatments:
Ferric Compounds
Iron
Iron isomaltoside 1000
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.