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

Primary Purpose

Iron Deficiency Anemia

Status

Withdrawn

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Iron isomaltoside 1000

Natrium Chloride 0,9%

About this trial

This is an interventional treatment trial for Iron Deficiency Anemia focused on measuring IDA, Iron deficiency, iron deficiency anemia and who are intolerant or unresponsive to oral iron therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Iron isomaltoside 1000

Placebo (NaCl 0,9%)

Arm Description

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

Sodium Chloride. Dose: 100 ml or 5 ml

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Time to Hb ≥ 2 g/dL

Full Information

NCT ID

NCT02172001

First Posted

June 21, 2014

Last Updated

September 27, 2016

Sponsor

Pharmacosmos A/S

1. Study Identification

Unique Protocol Identification Number

NCT02172001

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Withdrawn

Why Stopped

Study design not adequate

Study Start Date

undefined (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pharmacosmos A/S

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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..

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Iron Deficiency Anemia

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Iron isomaltoside 1000

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo (NaCl 0,9%)

Arm Type

Placebo Comparator

Arm Description

Sodium Chloride. Dose: 100 ml or 5 ml

Intervention Type

Drug

Intervention Name(s)

Iron isomaltoside 1000

Intervention Type

Drug

Intervention Name(s)

Natrium Chloride 0,9%

Intervention Description

100 ml or 5 ml

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

Time to Hb ≥ 2 g/dL

Time Frame

Week 1 to 5

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21237

Country

United States

12. IPD Sharing Statement

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

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