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

NCT02130063 | Completed Phase 3 Results

• 1 other identifier: P-Monofer-IDA-01
• Study Type: interventional
• Target: 511
• Locations: 1 country
• Sites: 1

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.

Conditions

Iron Deficiency Anaemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline to week 5

Secondary Outcomes (3)

• Change in Hb Concentration

  From baseline to week 2, 4 and 5

• Change in Serum (s)-Ferritin Concentration

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

• Change in Transferrin Saturation (TSAT)

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

Study Arms (2)

iron isomaltoside 1000 (Monofer®)

EXPERIMENTAL

iron isomaltoside 1000 (Monofer®)

Drug: iron isomaltoside 1000 (Monofer®)

iron sucrose (Venofer®)

ACTIVE COMPARATOR

iron sucrose (Venofer®)

Drug: iron sucrose (Venofer®)

Interventions

iron isomaltoside 1000 (Monofer®) DRUG

iron isomaltoside 1000 (Monofer®)

iron sucrose (Venofer®) DRUG

iron sucrose (Venofer®)

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 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pharmacosmos A/S: lead
• BioStata: collaborator
• ClinStar, LLC: collaborator
• Laboratory Corporation of America: collaborator

Study Sites (1)

Unknown Facility

Wilmington, Delaware, United States

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency; Iron Deficiencies

Interventions

iron isomaltoside 1000; Ferric Oxide, Saccharated

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Pharmacosmos

llt@pharmacosmos.com

+45 5948 5959

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2014
• First Posted: May 2, 2014
• Study Start: May 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 27, 2018
• Results First Posted: May 22, 2018

Record last verified: 2015-08

Locations

US (1)