Ferumoxytol for Iron Deficiency Anaemia in Nondialysis-dependent CKD
Research type
Research Study
Full title
A Randomized, Open-Label, Active-Controlled Study of the Safety, Efficacy, and Pharmacokinetics of Ferumoxytol Compared with Oral Iron for the Treatment of Iron Deficiency Anaemia in Paediatric Subjects with Nondialysis-dependent Chronic Kidney Disease (CKD).
IRAS ID
55073
Contact name
N Webb
Sponsor organisation
AMAG Pharmaceuticals Inc
Eudract number
2010-019388-12
Clinicaltrials.gov Identifier
Research summary
Ferumoxytol is an investigational drug which is to be tested on patients from 6 months old and up to the age of 18 who suffer from chronic kidney disease which results in Iron Deficient Anaemia. Iron Deficiency Anaemia (IDA) is a lack of red blood cells which can result in lack of oxygen being delivered to various organs. Participants with IDA may suffer from the following:- fatigue, lethargy, poor concentration, shortness of breath, palpitations and dizziness. IDA in young participants (paediatrics) could suffer from lack of motor skills and mental function and increased lead absorption. Anaemia has also been associated with behavioural and development delays. Long term effects of IDA, Chronic Kidney Disease (which may be referred to as CKD) could result in problems with neurodevelopment impairment and problems with central nervous system damage cause by increased lead absorption.The objective of this study is to test the effectiveness and safety of Ferumoxytol on participants who suffer from iron deficient anaemia, and or CKD. These participants may also have been recipients of a kidney transplant but will not be receiving dialysis.Oral iron is generally used to treat IDA in the general population so this will be used as a comparator with two dose regimens of Ferumoxytol.This study is a 3 arm study which means that there are 3 types of treatment which the participant could be assigned to.Oral Iron 2.5 mg Fe/kg twice daily by mouth (maximum 100 mg/dose)Four doses of 3.5mg Fe/kg (maximum 255 mg/dose) Ferumoxytol by IV injection.Two doses of 7.0 mg Fe/kg (maximum 510 mg/dose) Ferumoxytol by IV injectionThe study will last for up to a maximum of 9 weeks.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
10/H1008/89
Date of REC Opinion
31 Jan 2011
REC opinion
Further Information Favourable Opinion