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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-04)

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ClinicalTrials.gov Identifier: NCT03238911
Recruitment Status : Completed
First Posted : August 3, 2017
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Pharmacosmos A/S

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 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-04)
Actual Study Start Date : October 24, 2017
Actual Primary Completion Date : June 19, 2018
Actual Study Completion Date : June 19, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arm Intervention/treatment
Experimental: Iron Isomaltoside
Iron Isomaltoside (Monofer) administered IV
Drug: Iron isomaltoside (Monofer)
administered IV

Active Comparator: Ferric Carboxymaltose
Ferric Carboxymaltose (Injectafer) administered IV
Drug: Ferric carboxymaltose
administered IV
Other Name: Injectafer




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

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 ]


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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.

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): NCT03238911


Locations
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United States, Florida
LMG Research
Miami, Florida, United States, 33125
Sponsors and Collaborators
Pharmacosmos A/S

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Responsible Party: Pharmacosmos A/S
ClinicalTrials.gov Identifier: NCT03238911     History of Changes
Other Study ID Numbers: P-Monofer-IDA-04
First Posted: August 3, 2017    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: December 2017

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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