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

Iron-deficiency Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01895231
• Other study ID #: P-Monofer-BD-02
• Status: Completed
• Phase: Phase 3
• First received: June 26, 2013
• Last updated: March 14, 2018
• Start date: June 2013
• Est. completion date: December 2016

Study information

• Verified date: March 2018
• Source: Pharmacosmos A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron-deficiency

Intervention

Drug:
• Iron isomaltoside 1000 (Monofer®)

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Pharmacosmos A/S	Max Neeman

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Hb concentration	Change in Hb concentrations from baseline to right before second donation	From baseline and until t=3 months
Secondary	Ability to complete 3 blood donations	Number of subjects who cannot complete three donations due to low Hb	From baseline and until t=6 months
Secondary	Change in p-iron		From baseline and until week 12
Secondary	Change in fatigue symptoms		From baseline and until week 12
Secondary	Exercise tolerance	Change in exercise tolerance from baseline to 3 weeks after baseline measured by a two-step test on bike	From baseline to week 3
Secondary	Number of adverse drug reactions		From screening and until t= 6 months
Secondary	Change in p-ferritin		From baseline and until week 12
Secondary	Change in Transferrin Saturation (TSAT)		From baseline until week 12
Secondary	Change in reticulocyte count		From Baseline to week 12
Secondary	Change in haematology parameters		From baseline and until t= 6 months
Secondary	Change in RLS symptoms		From baseline and until t= 6 months