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IDA-01 A Randomised, Open-Label, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) and Iron Sucrose (Provide)

Primary Purpose

Iron Deficiency Anaemia

Status

Completed

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

iron isomaltoside 1000 (Monofer®)

iron sucrose (Venofer®)

About this trial

This is an interventional treatment trial for Iron Deficiency Anaemia focused on measuring IDA, Iron deficiency, iron deficiency anaemia 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 abnormal uterine bleeding, gastrointestinal diseases, cancer, bariatric procedures (gastric bypass operations), and other conditions leading to significant blood loss and with a documented history of intolerance or unresponsiveness to oral iron therapy for at least one month prior to study enrollment or where there at investigators judgment is a clinical need to deliver iron rapidly
Hb < 11 g/dL
TSAT < 20 %
S-ferritin < 100 ng/mL
Willingness to participate and signing the informed consent form

Exclusion Criteria:

Anaemia predominantly caused by factors other than IDA (e.g. anaemia with untreated vitamin B12 or folate deficiency, haemolytic anaemia)
Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
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
Rheumatoid arthritis with symptoms or signs of active inflammation
Pregnant or nursing women. In order to avoid pregnancy, women have to be surgically sterile or use adequate contraception (e.g. intrauterine devices, hormonal contraceptives, or double barrier method) during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product
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 iron treatment or blood transfusion within 4 weeks prior to the screening visit
Planned elective surgery during the study
Participation in any other 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 ischaemic heart disease, or uncontrolled diabetes mellitus

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

iron isomaltoside 1000 (Monofer®)

iron sucrose (Venofer®)

Arm Description

iron isomaltoside 1000 (Monofer®)

iron sucrose (Venofer®)

Outcomes

Primary Outcome Measures

Number of Subjects With an Haemoglobin (Hb) Increase of ≥ 2 g/dL From Baseline at Any Time From Week 1 to Week 5

The primary efficacy endpoint of the trial was the count of subjects with an Hb increase of ≥ 2 g/dL from baseline at any time from week 1 to week 5. 'Any time' implied that if the endpoint was met at a time-point prior to or at week 5, the effect (increase of ≥ 2 g/dL) did not have to be maintained throughout the trial in order for a subject to be a responder. Number of responders (i.e. a subject with increase in Hb ≥ 2 g/dL from baseline at any time from week 1 to week 5) and percentages according to number of subjects in the analysis set were summarised.

Secondary Outcome Measures

Change in Hb Concentration

Change in Serum (s)-Ferritin Concentration

Change in Transferrin Saturation (TSAT)

Full Information

NCT ID

NCT02130063

First Posted

April 28, 2014

Last Updated

August 30, 2018

Sponsor

Pharmacosmos A/S

Collaborators

BioStata, ClinStar, LLC, Laboratory Corporation of America

1. Study Identification

Unique Protocol Identification Number

NCT02130063

Brief Title

IDA-01 A Randomised, Open-Label, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) and Iron Sucrose

Acronym

Provide

Official Title

A Phase III, Randomised, Open-Label, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) and Iron Sucrose in Subjects With Iron Deficiency Anaemia and Who Are Intolerant or Unresponsive to Oral Iron Therapy or Who Need Iron Rapidly (PROVIDE)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2015

Overall Recruitment Status

Completed

Study Start Date

May 2014 (undefined)

Primary Completion Date

August 2015 (Actual)

Study Completion Date

August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pharmacosmos A/S

Collaborators

BioStata, ClinStar, LLC, Laboratory Corporation of America

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of the trial is to evaluate and compare the effect of iron isomaltoside 1000 to iron sucrose in its ability to increase haemoglobin (Hb) in subjects with IDA when oral iron preparations are ineffective or cannot be used or where there is a clinical need to deliver iron rapidly.

Detailed Description

IDA is highly prevalent in subjects with gastrointestinal diseases and cancer, menstruating or pregnant women, and subjects who have undergone bariatric procedure. IDA can have a substantial medical and quality of life (QoL) burden on the subjects and the treatment of these subjects includes controlling the bleeding and 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 another parenteral iron preparation (iron sucrose) in subjects with IDA and who are intolerant or unresponsive to oral iron therapy or who need iron rapidly.

6. Conditions and Keywords

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

Iron Deficiency Anaemia

Keywords

IDA, Iron deficiency, iron deficiency anaemia 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

None (Open Label)

Allocation

Randomized

Enrollment

511 (Actual)

8. Arms, Groups, and Interventions

Arm Title

iron isomaltoside 1000 (Monofer®)

Arm Type

Experimental

Arm Description

iron isomaltoside 1000 (Monofer®)

Arm Title

iron sucrose (Venofer®)

Arm Type

Active Comparator

Arm Description

iron sucrose (Venofer®)

Intervention Type

Drug

Intervention Name(s)

iron isomaltoside 1000 (Monofer®)

Intervention Type

Drug

Intervention Name(s)

iron sucrose (Venofer®)

Primary Outcome Measure Information:

Title

Number of Subjects With an Haemoglobin (Hb) Increase of ≥ 2 g/dL From Baseline at Any Time From Week 1 to Week 5

Description

Time Frame

From baseline to week 5

Secondary Outcome Measure Information:

Title

Change in Hb Concentration

Time Frame

From baseline to week 2, 4 and 5

Title

Change in Serum (s)-Ferritin Concentration

Time Frame

From baseline to week 1, 2, 4, and 5

Title

Change in Transferrin Saturation (TSAT)

Time Frame

From baseline to week 1, 2, 4, and 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 abnormal uterine bleeding, gastrointestinal diseases, cancer, bariatric procedures (gastric bypass operations), and other conditions leading to significant blood loss and with a documented history of intolerance or unresponsiveness to oral iron therapy for at least one month prior to study enrollment or where there at investigators judgment is a clinical need to deliver iron rapidly Hb < 11 g/dL TSAT < 20 % S-ferritin < 100 ng/mL Willingness to participate and signing the informed consent form Exclusion Criteria: Anaemia predominantly caused by factors other than IDA (e.g. anaemia with untreated vitamin B12 or folate deficiency, haemolytic anaemia) Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis) 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 Rheumatoid arthritis with symptoms or signs of active inflammation Pregnant or nursing women. In order to avoid pregnancy, women have to be surgically sterile or use adequate contraception (e.g. intrauterine devices, hormonal contraceptives, or double barrier method) during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product 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 iron treatment or blood transfusion within 4 weeks prior to the screening visit Planned elective surgery during the study Participation in any other 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 ischaemic heart disease, or uncontrolled diabetes mellitus

Facility Information:

City

Wilmington

State/Province

Delaware

Country

United States

12. IPD Sharing Statement

Learn more about this trial

IDA-01 A Randomised, Open-Label, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) and Iron Sucrose

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