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Completed

NCT Number: NCT03237065

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

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).

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Key information

Conditions

Iron Deficiency Anaemia Anemia Anemia, Hypochromic Anemia, Iron-Deficiency Hematologic Diseases Hemic and Lymphatic Diseases Hypophosphatemia Iron Deficiencies Iron Deficiency Anemia Iron Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Phosphorus Metabolism Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pharmacosmos Investigational Site, Muscle Shoals, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Iron isomaltoside/ferric derisomaltose

Drug

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).

Other names: Monofer®, Monoferric®, Monover®, Monofar®, Monoferro®

ferric carboxymaltose

Drug

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).

Other names: Injectafer®, Ferinject®

Primary outcomes

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

    Time frame: Baseline to day 35

    Safety

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

Secondary outcomes

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

    Time frame: Baseline to day 35

    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.

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

    Time frame: Baseline to day 35

    Safety

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

  3. 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

    Safety

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

  4. 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

    Safety

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

  5. Change From Baseline in Fractional Phosphate Urinary Excretion

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

    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 %.

  6. Change in Concentration of (Intact) Fibroblast Growth Factor 23 (iFGF23) From Baseline to Day 1, 7, 8, 14, 21, and 35

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

    Safety

    Change in concentration of (Intact) Fibroblast Growth Factor 23 (iFGF23) from baseline to day 1, 7, 8, 14, 21, and 35.

  7. Change in C-terminal Fibroblast Growth Factor 23 (cFGF23) From Baseline to Days 1, 7, 8, 14, 21, and 35

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

    Safety

    Change in C-terminal Fibroblast Growth Factor 23 (cFGF23) from baseline to days 1, 7, 8, 14, 21, and 35.

  8. Change in Vitamin 25-Hydroxyvitamin D (Vitamin D 25) From Baseline to Days 1, 7, 8, 14, 21, and 35

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

    Safety

    Change in vitamin 25-Hydroxyvitamin D (vitamin D 25) from baseline to days 1, 7, 8, 14, 21, and 35.

  9. Change in 1,25-Dihydroxyvitamin D (Vitamin D 1.25) From Baseline to Days 1, 7, 8, 14, 21, and 35

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

    Safety

    Change in 1,25-Dihydroxyvitamin D (vitamin D 1.25) from baseline to days 1, 7, 8, 14, 21, and 35.

  10. Change in 24,25-Dihydroxyvitamin D (Vitamin D 24.25) From Baseline to Days 1, 7, 8, 14, 21, and 35

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

    Safety

    Change in 24,25-Dihydroxyvitamin D (vitamin D 24.25) from baseline to days 1, 7, 8, 14, 21, and 35.

  11. Change in Intact Parathyroid Hormone (PTH) From Baseline to Days 1, 7, 8, 14, 21, and 35

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

    Safety

    Change in intact Parathyroid hormone (PTH) from baseline to days 1, 7, 8, 14, 21, and 35.

  12. Change in Ionized Calcium From Baseline to Days 1, 7, 8, 14, 21, and 35

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

    Safety

    Change in ionized calcium from baseline to days 1, 7, 8, 14, 21, and 35.

  13. Incidence of Protocol-defined Serious or Severe Hypersensitivity Reactions

    Time frame: Baseline to day 35

    Safety

    For this endpoint, the number of participants with serious or severe hypersensitivity reactions were evaluated.

  14. Change in Hemoglobin (Hb) Per Gram Iron From Baseline to Days 1, 7, 8, 14, 21, and 35

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

    Efficacy

    Change in hemoglobin (Hb) per gram iron from baseline to days 1, 7, 8, 14, 21, and 35.

  15. Change in S-ferritin From Baseline to Days 1, 7, 8, 14, 21, and 35

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

    Efficacy

    Change in s-ferritin from baseline to days 1, 7, 8, 14, 21, and 35.

  16. Change in Transferrin Saturation (TSAT) From Baseline to Days 1, 7, 8, 14, 21, and 35

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

    Efficacy

    Change in Transferrin Saturation (TSAT) from baseline to days 1, 7, 8, 14, 21, and 35.

    TSAT is the value of serum iron divided by the total iron-binding capacity and the unit is %, which referrers to % of iron-binding sites of transferrin being occupied by iron.

Sponsors and collaborators

Lead sponsor

Pharmacosmos A/S

Industry

Registry information

Official study title

A Randomized, Open-label, Comparative Trial Comparing the Incidence of Hypophosphatemia in Relation to Treatment With Iron Isomaltoside/Ferric Derisomaltose and Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia (Phosphare-IDA-05)

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 2, 2017
Registry last updated
Feb 25, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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