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

Pharmacosmos

Status and phase: Completed; Phase 3

Conditions: Iron Deficiency Anemia; Iron Deficiency Anaemia

Treatments: Drug: Iron isomaltoside/ferric derisomaltose; Drug: Ferric carboxymaltose

Study type: Interventional

Funder types: Industry

Identifiers

NCT03237065

P-Monofer-IDA-05

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 122 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

122 participants in 2 patient groups

Iron isomaltoside/ferric derisomaltose

Experimental group

Description:

Administered IV

Treatment:

Drug: Iron isomaltoside/ferric derisomaltose

Ferric carboxymaltose

Active Comparator group

Description:

Administered IV

Treatment:

Drug: Ferric carboxymaltose