Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose vs Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia
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Lead
Pharmacosmos A/S
This trial was designed to evaluate the effect of IV iron isomaltoside/ferric derisomaltose compared with IV ferric carboxymaltose on s-phosphate in subjects with IDA caused by different etiologies.
The subjects received either a single intravenous (IV) dose of iron isomaltoside/ferric derisomaltose (1000 mg at baseline) or two IV doses of ferric carboxymaltose (one dose 750 mg at baseline and a second dose 750 mg on day 7; cumulative dose: 1500 mg). The study subjects were monitored for up to 35 days from baseline.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Subjects diagnosed with IDA, caused by different aetiologies
Willingness to participate and signing the Informed Consent Form (ICF)
You may not be if
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.
Clareo Health | Incidence of Hypophosphatemia After Treatment With Iron Isomaltoside/Ferric Derisomaltose vs Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia
