A Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by Infusions to Iron-deficient Blood Donors

NCT01895231 | Completed Phase 3

• 1 other identifier: P-Monofer-BD-02
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of the study is to evaluate the effect of IV iron isomaltoside 1000 compared with placebo on Hb in first-time female donors with p-ferritin below 30 µg/L

Conditions

Iron-deficiency

Outcome Measures

Primary Outcomes (1)

• Change in Hb concentration

  The primary endpoint is to measure and compare the change in Hb concentration from baseline to right before the third blood donation in the two study arms

  From baseline and until t= 6 months

Secondary Outcomes (11)

• Change in Hb concentration

  From baseline and until t=3 months

• Ability to complete 3 blood donations

  From baseline and until t=6 months

• Change in p-iron

  From baseline and until week 12

• Change in fatigue symptoms

  From baseline and until week 12

• Exercise tolerance

  From baseline to week 3

Study Arms (2)

Iron isomaltoside 1000

EXPERIMENTAL

Monofer® 1000 mg IV infusion over 15 minutes

Drug: Iron isomaltoside 1000 (Monofer®)

Placebo

PLACEBO COMPARATOR

0.9 % saline Infusion over 15 min

Drug: Placebo

Interventions

Iron isomaltoside 1000 (Monofer®) DRUG

Also known as: Monofer®

Iron isomaltoside 1000

Placebo DRUG

Also known as: 0.9 % saline

Placebo

Eligibility Criteria

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

You may qualify if:

• Women aged ≥ 18 years
• First-time donor
• P-ferritin \< 30 µg/L
• Willingness to participate and signed the informed consent form

You may not qualify if:

• Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
• Known hypersensitivity to any excipients in the investigational drug products
• History of drug related allergies
• History of severe asthma
• Decompensated liver cirrhosis and hepatitis (defined as 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))
• Rheumatoid arthritis with symptoms or signs of active inflammation
• Subjects who are pregnant or nursing. In order to avoid pregnancy, women have to be postmenopausal (at least 12 months since last menstruation), surgically sterile, or use one of the following contraceptives 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: intrauterine devices and hormonal contraceptives (contraceptive pills, implants, transdermal patches, vaginal devices, or hormonal injections with prolonged release)
• Participation in any other clinical study where the study drug has not passed 5 half-lives prior to the screening
• Untreated vitamin B12 or folate deficiency
• Treated with other IV or oral iron products within 4 weeks prior to the screening
• Treated with Erythropoietin (EPO) within 4 weeks prior to the screening
• Any other medical condition that, in the opinion of the 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

Sponsors & Collaborators

• Pharmacosmos A/S: lead
• Max Neeman: collaborator

Study Sites (1)

Unknown Facility

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Anemia, Iron-Deficiency

Interventions

iron isomaltoside 1000; Sodium Chloride

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Nørgaard

  RH Blodbanken

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 26, 2013
• First Posted: July 10, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 15, 2018

Record last verified: 2018-03

Locations

DK (1)