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

NCT02172001 | Withdrawn Phase 3

• 1 other identifier: P-Monofer-IDA-02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron Deficiency Anemia

Keywords

IDA; Iron deficiency; iron deficiency anemia and who are intolerant or unresponsive to oral iron therapy

Outcome Measures

Primary Outcomes (1)

• Proportion of subjects with an Hb increase of ≥ 2 g/dL from baseline at any time from week 1 to week 5

  Week 1 to 5

Secondary Outcomes (1)

• Time to Hb ≥ 2 g/dL

  Week 1 to 5

Study Arms (2)

Iron isomaltoside 1000

EXPERIMENTAL

Iron isomaltoside 1000. Dose: 1000 mg, 1500 mg or 2000 mg

Drug: Iron isomaltoside 1000

Placebo (NaCl 0,9%)

PLACEBO COMPARATOR

Sodium Chloride. Dose: 100 ml or 5 ml

Drug: Natrium Chloride 0,9%

Interventions

Iron isomaltoside 1000 DRUG

Iron isomaltoside 1000

Natrium Chloride 0,9% DRUG

100 ml or 5 ml

Placebo (NaCl 0,9%)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Pharmacosmos A/S: lead

Study Sites (1)

Unknown Facility

Baltimore, Maryland, 21237, United States

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Iron Deficiencies

Interventions

iron isomaltoside 1000

Condition Hierarchy (Ancestors)

Anemia, Hypochromic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2014
• First Posted: June 24, 2014
• Primary Completion: March 1, 2015
• Last Updated: September 28, 2016

Record last verified: 2016-03

Locations

US (1)