IDA-02 PhIII Monofer Subjects with Iron Deficiency Anaemia_04JUL2014
Research type
Research Study
Full title
A Phase III, Randomised, Double-blind, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer) against Placebo in Subjects with Iron Deficiency Anaemia and who are Intolerant or Unresponsive to Oral Iron Therapy
IRAS ID
160134
Contact name
Fraser Cummings
Contact email
Sponsor organisation
Pharmacosmos A/S
Eudract number
2014-001518-25
Clinicaltrials.gov Identifier
Research summary
Iron deficiency anaemia is highly prevalent and has a substantial medical and quality of life impact on patients. Establishing the cause of iron loss and adequately replenishing iron stores is central to management of these patients. Oral iron is the first line treatment to replace iron stores, however it may not be tolerated by up to 20% of patients. Further more, a significant proportion of patients despite tolerating oral iron do not replete their stores. Intravenous iron is therefore an important alternative treatment for these patients.
Iron isomaltoside 1000 (Monofer®) is a formulation developed and manufactured by Pharmacosmos A/S which has a low immunological potential. Hence, a test dose is not necessary (unlike some other preparations). Iron isomaltoside 1000 has strongly bound iron, which enables a controlled and slow release of bioavailable iron to the iron-binding proteins with little risk of free iron toxicity. This allows flexible high dosing and rapid iron repletion.
The study will include 200 subjects within 4 countries (Germany, Russia, UK and USA) with iron deficiency anaemia (IDA) due to a range of diagnosis and who are intolerant or unresponsive to oral iron therapy. The participants will be randomised and will receive either Monofer® or a placebo. The primary endpoint of the study is to evaluate and compare the effect of iron isomaltoside 1000 to placebo in its ability to increase haemoglobin (Hb). The secondary endpoints are to compare the effect of iron isomaltoside 1000 and placebo on other relevant iron related biochemical parameters, fatigue symptoms, restless leg syndrome (RLS) symptoms and quality of life. For the each individual subject, duration of the study will be approximately 5-7 weeks and each subject will attend 7 visits. The total duration of the study is 14 months, which includes a 12-months enrolment period.REC name
South Central - Oxford B Research Ethics Committee
REC reference
14/SC/1241
Date of REC Opinion
8 Oct 2014
REC opinion
Further Information Favourable Opinion