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A Trial Comparing the Incidence of Hypophosphatemia in Relation to Treatment With Iron Isomaltoside and Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia (IDA-05)

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ClinicalTrials.gov Identifier: NCT03237065
Recruitment Status : Completed
First Posted : August 2, 2017
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Pharmacosmos A/S

Study Description
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Brief Summary:
Treatment with iron isomaltoside and ferric carboxymaltose in subjects with iron deficiency anaemia and comparison of the incidence of hypophosphatemia.

Condition or disease Intervention/treatment Phase
IDA - Iron Deficiency Anemia Drug: Iron Isomaltoside (Monofer) Drug: Ferric carboxymaltose Phase 3

Detailed Description:

Existing IV iron complexes differ in relation to the compounds capability to induce unintended hypophosphatemia to a degree defined as medical significant.

This trial is designed evaluate the effect of IV iron isomaltoside compared to IV ferric carboxymaltose on phosphate in subjects with IDA


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Open-label, Comparative Trial Comparing the Incidence of Hypophosphatemia in Relation to Treatment With Iron Isomaltoside and Ferric Carboxymaltose in Subjects With Iron Deficiency Anaemia (IDA-05)
Actual Study Start Date : October 30, 2017
Actual Primary Completion Date : May 29, 2018
Actual Study Completion Date : May 29, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arms and Interventions
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Arm Intervention/treatment
Experimental: Iron isomaltoside (Monofer)
Administered iv
 Drug: Iron Isomaltoside (Monofer)
administered IV
Active Comparator: ferric carboxymaltose (Injectafer)
Administered iv
 Drug: Ferric carboxymaltose
administered IV
Other Name: Injectafer


Outcome Measures
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Primary Outcome Measures :
  1. the incidence of hypophosphatemia [ Time Frame: At any time point within 35 days after beginning of treatment with trial drugs ]
    s-phosphate < 2 mg/dL


Secondary Outcome Measures :
  1. Incidence of s-phosphate < 1.0 mg/dL [ Time Frame: 35 days ]
  2. Time with hypophosphatemia [ Time Frame: 35 days ]
    time with s-phosphate < 2.0 mg/dL

  3. Proportion of subjects with hypophosphatemia [ Time Frame: day 35 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria include:

  • subjects having IDA caused by different aetiologies
  • Hb ≤ 11 g/dL
  • Body weight > 50 kg
  • S-ferritin < 100 ng/mL
  • eGFR ≥ 65 mL/min/1.73 m2
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03237065


Locations
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United States, Indiana
Clinical Trials
Indianapolis, Indiana, United States, 46214-2985
Sponsors and Collaborators
Pharmacosmos A/S
More Information
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Responsible Party: Pharmacosmos A/S
ClinicalTrials.gov Identifier: NCT03237065     History of Changes
Other Study ID Numbers: P-Monofer-IDA-05
First Posted: August 2, 2017    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Anemia
Anemia, Iron-Deficiency
Deficiency Diseases
Hypophosphatemia
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Malnutrition
Nutrition Disorders
 Phosphorus Metabolism Disorders
Iron
Ferric Compounds
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hematinics