2104-005 Iron Deficiency Anaemia

• Research type

  Research Study

• Full title

  A Phase III, Randomized, Open-label, Active-Controlled Trial Comparing Ferumoxytol with Iron Sucrose for the Treatment of Iron Deficiency Anemia

• IRAS ID

  51164

• Contact name

  Roberto Stasi

• Sponsor organisation

  AMAG Pharmaceuticals, Inc.

• Eudract number

  2010-018961-50

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The aim of this study is to see how well the study drug, ferumoxytol, works compared to iron sucrose for the treatment of iron deficiency anaemia (IDA) and to look at how safe it is to use this drug in patients. IDA occurs when there is not enough haemoglobin in the blood. Haemoglobin contains iron and is found in red blood cells which carry oxygen around the body. IDA is often caused by bleeding, either from the stomach and intestines (gastrointestinal (GI) tract), from unusually heavy menstrual periods (known as abnormal uterine bleeding or AUB), or during childbirth. Patients with cancer, other GI disorders, congestive heart failure, rheumatoid arthritis, or with not enough iron in their diet may also have IDA. Iron replacement therapy is the usual treatment for IDA; it works by restoring iron levels in the body, which then helps to correct anaemia. Anaemia can cause tiredness or lack of energy and can impact quality of life. Patients in this study will be randomly put into two treatment groups: either ferumoxytol or iron sucrose, using a 2:1 ratio. Improvement in iron deficiency will be compared between the two groups. Ferumoxytol has already been studied as a treatment for IDA in over 1,500 patients with chronic kidney disease (CKD) and is approved for the treatment of IDA in adult patients with CKD. This study is looking at the use of ferumoxytol in patients with IDA and other conditions. Patients will take part in the study for approximately 7 weeks. This includes a screening period of up to 2 weeks, followed by a 5 week treatment period. Approximately 600 patients will take part in this study worldwide.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  10/H0408/47

• Date of REC Opinion

  3 Aug 2010

• REC opinion

  Further Information Favourable Opinion