Phase 2 Study of Ferumoxytol in Adult Chronic Kidney Disease
Research type
Research Study
Full title
Ferumoxytol Compared to Iron Sucrose Trial (FIRST): A Randomized, Multicentre, Trial of Ferumoxytol Compared to Iron Sucrose for the Treatment of Iron Deficiency Anemia in Adult Subjects with Chronic Kidney Disease
IRAS ID
44718
Contact name
Iain Macdougall
Sponsor organisation
AMAG Pharmaceuticals Inc.
Eudract number
2009-015630-30
Clinicaltrials.gov Identifier
Research summary
A PHASE II STUDY TO EVALUATE THE SAFETY AND EFFICACY OF FERUMOXYTOL VERSUS IRON SUCROSE FOR THE TREATMENT OF IRON DEFICIENCY ANEMIA IN SUBJECTS WITH CHRONIC KIDNEY DISEASE.Anaemia is a deficiency in the number of red blood cells or in their haemoglobin content (oxygen containing component), resulting in pallor, shortness of breath, and a lack of energy. Iron deficiency is the most common cause of anaemia worldwide. The World Health Organisation estimates that 25% of the world's population (1.6 billion people) may suffer from iron deficiency anaemia. Iron sucrose is a standard form of treatment for iron deficiency anaemia (IDA.)Chronic Kidney Disease is a progressive loss of renal (kidney) function over a period of months or years. It is a growing worldwide public health concern. Chronic Kidney Disease can be assigned to five different stages based on the level of kidney function. Anaemia affects the majority of individuals with stage 5 (most severe stage of the disease a stage at which most patients will be on dialysis) Chronic Kidney Disease.This research study is looking at how safe and effective the administration of a 1.02g course of intravenous (delivered via an injection into the vein) ferumoxytol is compared to a course of 1.0g of intravenous iron sucrose for the treatment of iron deficiency anaemia in adults with Chronic Kidney Disease, to include both haemodialysis and nondialysis-dependent patients. Safety will be assessed by the reporting of side effects and effectiveness of ferumoxytol compared to iron sucrose will be assessed by measuring changes in haemoglobin levels. Subjects will participate in the study for 7 weeks, and approximately 150 subjects across 50 sites worldwide will take part in this research.
REC name
London - Dulwich Research Ethics Committee
REC reference
10/H0808/82
Date of REC Opinion
17 Aug 2010
REC opinion
Further Information Favourable Opinion