Iron-deficiency
Conditions
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.
Interventions
DRUGPlacebo
Sponsors
Max Neeman
Pharmacosmos A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hb concentration | From baseline and until t= 6 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in haematology parameters | From baseline and until t= 6 months | — |
| Change in RLS symptoms | From baseline and until t= 6 months | — |
| Change in Transferrin Saturation (TSAT) | From baseline until week 12 | — |
| Change in Hb concentration | From baseline and until t=3 months | Change in Hb concentrations from baseline to right before second donation |
| Ability to complete 3 blood donations | From baseline and until t=6 months | Number of subjects who cannot complete three donations due to low Hb |
| Change in reticulocyte count | From Baseline to week 12 | — |
| Change in fatigue symptoms | From baseline and until week 12 | — |
| Exercise tolerance | From baseline to week 3 | Change in exercise tolerance from baseline to 3 weeks after baseline measured by a two-step test on bike |
| Number of adverse drug reactions | From screening and until t= 6 months | — |
| Change in p-ferritin | From baseline and until week 12 | — |
| Change in p-iron | From baseline and until week 12 | — |
Countries
Denmark
Outcome results
None listed