IDA-01 A Randomised, Open-Label, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer… (NCT02130063) | Clinical Trial Compass
CompletedPhase 3
IDA-01 A Randomised, Open-Label, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) and Iron Sucrose
United States511 participantsStarted 2014-05
Plain-language summary
The purpose of the trial is to evaluate and compare the effect of iron isomaltoside 1000 to iron sucrose in its ability to increase haemoglobin (Hb) in subjects with IDA when oral iron preparations are ineffective or cannot be used or where there is a clinical need to deliver iron rapidly.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Men or women \> 18 years having IDA caused by different aetiologies such as abnormal uterine bleeding, gastrointestinal diseases, cancer, bariatric procedures (gastric bypass operations), and other conditions leading to significant blood loss and with a documented history of intolerance or unresponsiveness to oral iron therapy for at least one month prior to study enrollment or where there at investigators judgment is a clinical need to deliver iron rapidly
✓. Hb \< 11 g/dL
✓. TSAT \< 20 %
✓. S-ferritin \< 100 ng/mL
✓. Willingness to participate and signing the informed consent form
Exclusion criteria
✕. Anaemia predominantly caused by factors other than IDA (e.g. anaemia with untreated vitamin B12 or folate deficiency, haemolytic anaemia)
✕. Iron overload or disturbances in utilisation of iron (e.g. haemochromatosis and haemosiderosis)
✕. Decompensated liver cirrhosis or active hepatitis (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))
✕. Body weight \< 50 kg
✕. Rheumatoid arthritis with symptoms or signs of active inflammation
✕
What they're measuring
1
Number of Subjects With an Haemoglobin (Hb) Increase of ≥ 2 g/dL From Baseline at Any Time From Week 1 to Week 5
. Pregnant or nursing women. In order to avoid pregnancy, women have to be surgically sterile or use adequate contraception (e.g. intrauterine devices, hormonal contraceptives, or double barrier method) 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