Clinical trial NCT01895231: A Study of Intravenous Iron Isomaltoside 1000 (Monofer®) Administered by Infusions to Iron-deficient Blood Donors
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Iron-deficiency
Lead sponsor: Pharmacosmos A/S
Sponsor class: INDUSTRY
Collaborators: name: Max Neeman
First posted: 2013-07-10
Enrollment: 107
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Change in Hb concentration
timeFrame: From baseline and until t= 6 months
Secondary outcomes:
measure: Change in Hb concentration
timeFrame: From baseline and until t=3 months
measure: Ability to complete 3 blood donations
timeFrame: From baseline and until t=6 months
measure: Change in p-iron
timeFrame: From baseline and until week 12
measure: Change in fatigue symptoms
timeFrame: From baseline and until week 12
measure: Exercise tolerance
timeFrame: From baseline to week 3
measure: Number of adverse drug reactions
timeFrame: From screening and until t= 6 months
measure: Change in p-ferritin
timeFrame: From baseline and until week 12
measure: Change in Transferrin Saturation (TSAT)
timeFrame: From baseline until week 12
measure: Change in reticulocyte count
timeFrame: From Baseline to week 12
measure: Change in haematology parameters
timeFrame: From baseline and until t= 6 months
measure: Change in RLS symptoms
timeFrame: From baseline and until t= 6 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
Study officials:
affiliation: RH Blodbanken
name: Nørgaard
role: PRINCIPAL_INVESTIGATOR
References: