Overview

Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose vs Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia

Status:
Completed
Trial end date:
2018-06-19
Target enrollment:
0
Participant gender:
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 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Pharmacosmos A/S
Treatments:
Ferric Compounds
Iron
Iron isomaltoside 1000
Criteria
Inclusion Criteria include:

- Subjects diagnosed with 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.