- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02172001
A Randomized, Double-blind, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Against Placebo
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
Study Overview
Status
Conditions
Intervention / Treatment
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..
Study Type
Phase
- Phase 3
Contacts and Locations
Study Locations
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Maryland
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Baltimore, Maryland, United States, 21237
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
- Hb < 11 g/dL
- TSAT < 20 %
- S-ferritin < 100 ng/mL
- Willingness to participate and signing the informed consent form (ICF)
Exclusion Criteria:
- Hb < 6 g/dL
- Anaemia predominantly caused by factors other than IDA (e.g. anaemia with untreat-ed vitamin B12 or folate deficiency, haemolytic anaemia)
- Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and hae-mosiderosis)
- Decompensated liver cirrhosis or active hepatitis (ALAT > 3 times upper limit of normal)
- Active acute or chronic infections (assessed by clinical judgement supplied with white blood cells (WBC) and C-reactive protein (CRP))
- Body weight < 50 kg
- 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
- History of multiple allergies
- Known hypersensitivity to parenteral iron or any excipients in the investigational drug products
- Erythropoietin treatment within 8 weeks prior to the screening visit
- Other intravenous (IV) iron treatment or blood transfusion within 4 weeks prior to the screening visit
- Participation in any other interventional clinical study within 3 months prior to the screening
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Iron isomaltoside 1000
Iron isomaltoside 1000.
Dose: 1000 mg, 1500 mg or 2000 mg
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Placebo Comparator: Placebo (NaCl 0,9%)
Sodium Chloride.
Dose: 100 ml or 5 ml
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100 ml or 5 ml
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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Week 1 to 5
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to Hb ≥ 2 g/dL
Time Frame: Week 1 to 5
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Week 1 to 5
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P-Monofer-IDA-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Iron Deficiency Anemia
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Clinical Trials on Iron isomaltoside 1000
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Pharmacosmos A/SCompleted
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Pharmacosmos A/SCompletedInflammatory Bowel DiseaseDenmark
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Seoul National University HospitalCompletedAnemia | Knee ArthropathyKorea, Republic of
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Pharmacosmos A/SCompletedPatients With Chemotherapy Induced Anemia (CIA)United States
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University of MalayaRecruitingAnemia | Post Partum HemorrhageMalaysia
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Pharmacosmos A/SBioStataCompletedAnaemia in Chronic Kidney DiseaseSweden, United Kingdom
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Pharmacosmos UK LtdBioStataCompletedIron Deficiency AnaemiaUnited Kingdom
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Pharmacosmos A/SBioStataCompletedIron Deficiency AnemiaDenmark
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Pharmacosmos A/SCompletedAnemia | Iron Metabolism Disorders | Deficiency Diseases | Anemia, Iron Deficiency | Hematologic DiseaseJapan
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Pharmacosmos A/SCompleted