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.