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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Pharmacosmos A/S
Sponsor:
Collaborator:
Max Neeman
Information provided by (Responsible Party):
Pharmacosmos A/S
ClinicalTrials.gov Identifier:
NCT01895231
First received: June 26, 2013
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

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


Condition Intervention Phase
Iron-deficiency
Drug: Iron isomaltoside 1000 (Monofer®)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Prospective, Double-Blind, Comparative Placebo-Controlled Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by Infusions to Iron-Deficient Blood Donors

Resource links provided by NLM:


Further study details as provided by Pharmacosmos A/S:

Primary Outcome Measures:
  • Change in Hb concentration [ Time Frame: From baseline and until t= 6 months ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Change in Hb concentration [ Time Frame: From baseline and until t=3 months ] [ Designated as safety issue: No ]
    Change in Hb concentrations from baseline to right before second donation

  • Ability to complete 3 blood donations [ Time Frame: From baseline and until t=6 months ] [ Designated as safety issue: No ]
    Number of subjects who cannot complete three donations due to low Hb

  • Change in p-iron [ Time Frame: From baseline and until week 12 ] [ Designated as safety issue: No ]
  • Change in fatigue symptoms [ Time Frame: From baseline and until week 12 ] [ Designated as safety issue: No ]
  • Exercise tolerance [ Time Frame: From baseline to week 3 ] [ Designated as safety issue: No ]
    Change in exercise tolerance from baseline to 3 weeks after baseline measured by a two-step test on bike

  • Number of adverse drug reactions [ Time Frame: From screening and until t= 6 months ] [ Designated as safety issue: Yes ]
  • Change in p-ferritin [ Time Frame: From baseline and until week 12 ] [ Designated as safety issue: No ]
  • Change in Transferrin Saturation (TSAT) [ Time Frame: From baseline until week 12 ] [ Designated as safety issue: No ]
  • Change in reticulocyte count [ Time Frame: From Baseline to week 12 ] [ Designated as safety issue: No ]
  • Change in haematology parameters [ Time Frame: From baseline and until t= 6 months ] [ Designated as safety issue: Yes ]
  • Change in RLS symptoms [ Time Frame: From baseline and until t= 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2013
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Iron isomaltoside 1000
Monofer® 1000 mg IV infusion over 15 minutes
Drug: Iron isomaltoside 1000 (Monofer®)
Other Name: Monofer®
Placebo Comparator: Placebo
0.9 % saline Infusion over 15 min
Drug: Placebo
Other Name: 0.9 % saline

Detailed Description:

At present, clinical efficacy and safety data is available for iron isomaltoside 1000 administered to patients with IDA requiring iron therapy. However, there is a need for clinical efficacy and safety data within iron deficiency without anaemia which is e.g. observed in blood donors. Thus, this study is planned to compare the efficacy and safety of parenteral iron isomaltoside 1000 with placebo in female blood donors with a p-ferritin below 30 µg/L.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Women aged ≥ 18 years
  2. First-time donor
  3. P-ferritin < 30 µg/L
  4. Willingness to participate and signed the informed consent form

Exclusion Criteria:

  1. Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
  2. Known hypersensitivity to any excipients in the investigational drug products
  3. History of drug related allergies
  4. History of severe asthma
  5. Decompensated liver cirrhosis and hepatitis (defined as ALAT > 3 times upper limit of normal)
  6. Active acute or chronic infections (assessed by clinical judgement supplied with White Blood Cells (WBC) and C-Reactive Protein (CRP))
  7. Rheumatoid arthritis with symptoms or signs of active inflammation
  8. 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)
  9. Participation in any other clinical study where the study drug has not passed 5 half-lives prior to the screening
  10. Untreated vitamin B12 or folate deficiency
  11. Treated with other IV or oral iron products within 4 weeks prior to the screening
  12. Treated with Erythropoietin (EPO) within 4 weeks prior to the screening
  13. 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01895231

Contacts
Contact: Lars Lykke Thomsen +45 59 48 59 59 LLT@Pharmacosmos.com

Locations
Denmark
Recruiting
Copenhagen, Denmark
Sponsors and Collaborators
Pharmacosmos A/S
Max Neeman
  More Information

No publications provided

Responsible Party: Pharmacosmos A/S
ClinicalTrials.gov Identifier: NCT01895231     History of Changes
Other Study ID Numbers: P-Monofer-BD-02
Study First Received: June 26, 2013
Last Updated: April 28, 2014
Health Authority: Denmark: Danish Health and Medicines Authority

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Iron
Ferric Compounds
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014