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

Pharmacosmos A/S122 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

122

Conditions

Iron Deficiency Anaemia Iron Deficiency Anemia

Interventions

Iron isomaltoside/ferric derisomaltoseDRUG

Iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) was the test product in this trial. The dose of iron isomaltoside/ferric derisomaltose for the individual subject was a single IV infusion of 1000 mg (10 mL containing 1000 mg iron isomaltoside/ferric derisomaltose diluted in 100 mL 0.9 % sodium chloride), given over approximately 20 minutes (50 mg iron/min) at baseline (cumulative dose: 1000 mg).

Ferric carboxymaltoseDRUG

Ferric carboxymaltose (Injectafer®; 50 mg/mL) was the comparator in this trial. The dose of ferric carboxymaltose for the individual subject was 750 mg, infused over at least 15 minutes at baseline and on day 7 (cumulative dose: 1500 mg).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (15)

Pharmacosmos Investigational Site

Muscle Shoals, Alabama, United States

Pharmacosmos Investigational Site

Doral, Florida, United States

Outcomes

Primary Outcomes

Incidence of Hypophosphatemia (S-phosphate Level <2 mg/dL)

Safety The incidence of hypophosphatemia (defined as s-phosphate \<2 mg/dL) at any time from baseline up to day 35.

Time frame: Baseline to day 35

Secondary Outcomes

Time With Hypophosphatemia ( S-phosphate Level <2.0 mg/dL)

Safety Time with hypophosphatemia (i.e. time with s-phosphate level \< 2.0 mg/dL) from baseline up to day 35. The time with hypophosphatemia was calculated as the actual number of days from the first day where s-phosphate was \<2 mg/dL until the first day when s-phosphate was ≥2 mg/dL. If the subject did not reach s-phosphate ≥2 mg/dL, the subject was regarded as censored on day 35.

Time frame: Baseline to day 35

Proportion of Subjects With Hypophosphatemia on Day 35 (S-phosphate Level <2.0 mg/dL)

Safety Evaluate the proportion of subjects with hypophosphatemia (s-phosphate level \<2.0 mg/dL) on day 35.

Time frame: Baseline to day 35

Absolute [∆] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35

Safety Absolute \[∆\] changes in s-phosphate from baseline to day 1, 7, 8, 14, 21, and 35.

Time frame: Baseline, days 1, 7, 8, 14, 21, and 35

Relative [%] Changes in S-phosphate From Baseline to Day 1, 7, 8, 14, 21, and 35

Safety Relative \[%\] changes in s-phosphate from baseline to day 1, 7, 8, 14, 21, and 35.

Time frame: Baseline, days 1, 7, 8, 14, 21, and 35

Change From Baseline in Fractional Phosphate Urinary Excretion

Safety Change in absolute fractional phosphate urinary excretion from baseline to days 1, 7, 8, 14, 21, and 35. Fractional excretion of phosphate (FEPi) is calculated as (\[phosphate in urine X creatinine in serum\]/\[phosphate in serum X creatinine in urine\]) X 100, and the unit is %.

Data from ClinicalTrials.gov

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