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A Randomized, Double-blind, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Against Placebo

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ClinicalTrials.gov Identifier: NCT02172001
Recruitment Status : Withdrawn (Study design not adequate)
First Posted : June 24, 2014
Last Update Posted : September 28, 2016
Sponsor:
Information provided by (Responsible Party):
Pharmacosmos A/S

Brief Summary:
The primary objective of the study is to evaluate and compare the effect of iron isomaltoside 1000 to placebo in its ability to increase haemoglobin (Hb) in subjects with IDA when oral iron preparations are ineffective or cannot be used.

Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia Drug: Iron isomaltoside 1000 Drug: Natrium Chloride 0,9% Phase 3

Detailed Description:

IDA is highly prevalent in subjects and can have a substantial medical and quality of life (QoL) burden on the subjects and the treatment of these subjects includes replenishing lost iron. Oral iron administration is often used in the clinical practice at many clinics; however, oral iron may not be tolerated by all subjects. Hence, there is a need for an alternative iron treatment in subjects, who do not tolerate oral iron.

This study is planned to compare the efficacy and safety of iron isomaltoside 1000 with placebo in subjects with IDA and who are intolerant or unresponsive to oral iron therapy..


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Randomised, Double-blind, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Against Placebo in Subjects With Iron Deficiency Anaemia and Who Are Intol-erant or Unresponsive to Oral Iron Therapy
Actual Primary Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arm Intervention/treatment
Experimental: Iron isomaltoside 1000
Iron isomaltoside 1000. Dose: 1000 mg, 1500 mg or 2000 mg
Drug: Iron isomaltoside 1000
Placebo Comparator: Placebo (NaCl 0,9%)
Sodium Chloride. Dose: 100 ml or 5 ml
Drug: Natrium Chloride 0,9%
100 ml or 5 ml




Primary Outcome Measures :
  1. Proportion of subjects with an Hb increase of ≥ 2 g/dL from baseline at any time from week 1 to week 5 [ Time Frame: Week 1 to 5 ]

Secondary Outcome Measures :
  1. Time to Hb ≥ 2 g/dL [ Time Frame: Week 1 to 5 ]


Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Men or women ≥ 18 years having IDA caused by different aetiologies* such as ab-normal uterine bleeding, gastrointestinal diseases (e.g. inflammatory bowel disease), cancer, preoperative anaemia (e.g. orthopaedic surgery), and other conditions leading to IDA and with a documented history of intolerance or unresponsiveness to oral iron therapy** for at least one month*** prior to study enrolment
  2. Hb < 11 g/dL
  3. TSAT < 20 %
  4. S-ferritin < 100 ng/mL
  5. Willingness to participate and signing the informed consent form (ICF)

Exclusion Criteria:

  1. Hb < 6 g/dL
  2. Anaemia predominantly caused by factors other than IDA (e.g. anaemia with untreat-ed vitamin B12 or folate deficiency, haemolytic anaemia)
  3. Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and hae-mosiderosis)
  4. Decompensated liver cirrhosis or active hepatitis (ALAT > 3 times upper limit of normal)
  5. Active acute or chronic infections (assessed by clinical judgement supplied with white blood cells (WBC) and C-reactive protein (CRP))
  6. Body weight < 50 kg
  7. Pregnant or nursing women. In order to avoid pregnancy, women of childbearing po-tential have to use adequate contraception (e.g. intrauterine devices, hormonal contra-ceptives, or double barrier method) during the whole study period and 7 days after the last dosing
  8. History of multiple allergies
  9. Known hypersensitivity to parenteral iron or any excipients in the investigational drug products
  10. Erythropoietin treatment within 8 weeks prior to the screening visit
  11. Other intravenous (IV) iron treatment or blood transfusion within 4 weeks prior to the screening visit
  12. Participation in any other interventional clinical study within 3 months prior to the screening
  13. Any other medical condition that, in the opinion of Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study, e.g. uncontrolled hypertension, unstable ischemic heart disease, or uncontrolled diabetes mellitus

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): NCT02172001


Locations
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United States, Maryland
Baltimore, Maryland, United States, 21237
Sponsors and Collaborators
Pharmacosmos A/S

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Responsible Party: Pharmacosmos A/S
ClinicalTrials.gov Identifier: NCT02172001     History of Changes
Other Study ID Numbers: P-Monofer-IDA-02
First Posted: June 24, 2014    Key Record Dates
Last Update Posted: September 28, 2016
Last Verified: March 2016

Keywords provided by Pharmacosmos A/S:
IDA
Iron deficiency
iron deficiency anemia and who are intolerant or unresponsive to oral iron therapy

Additional relevant MeSH terms:
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Anemia
Anemia, Iron-Deficiency
Deficiency Diseases
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Malnutrition
Nutrition Disorders
Iron
Iron isomaltoside 1000
Ferric Compounds
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hematinics