Extension Study of Ferumoxytol for Iron Deficiency Anaemia in CKD

• Research type

  Research Study

• Full title

  An Open-Label Extension Study of the Safety and Efficacy of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anaemia in Paediatric Subjects with Chronic Kidney Disease (CKD).

• IRAS ID

  55074

• Contact name

  N Webb

• Sponsor organisation

  AMAG Pharmaceuticals Inc

• Eudract number

  2010-019550-40

• Research summary

  The purpose of this research study is to further evaluate the experimental drug Feraheme ™Injection (referred to as ‘ferumoxytol’ or ‘study drug’), to see how well it works for treating episodes of iron deficiency anaemia (IDA) in children with chronic kidney disease (CKD). The study will also look at how safe the study drug, fermoxytol, is and how often children with IDA need to be given the study drug to help their IDA. Children with CKD who have already taken part in one of two other studies (AMAG-FER-CKD-251 or AMAG-FER-CKD-252) will be asked to take part in this extension study. Each study subject can stay in this extension study for up to 25 months and will be given the study drug, ferumoxytol, during the study when needed if they have IDA. Iron is a key component of the haemoglobin molecule found in red blood cells in the blood where it serves a vital role in transporting oxygen around the body. Lack of iron in the body's known as iron deficiency. IDA can cause a number of symptoms including fatigue, lethargy, poor concentration, shortness of breath, palpitations, and dizziness and is associated with a number of disease conditions one being chronic kidney disease (CKD). IDA is common in adults and children who have CKD. Iron therapy is the usual treatment for IDA. Iron therapy restores iron levels and helps the body normalize levels of haemoglobin (the part of the red blood cells in the blood that carry oxygen).

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/H1008/105

• Date of REC Opinion

  18 Feb 2011

• REC opinion

  Further Information Favourable Opinion