Ferumoxytol for Iron Deficiency Anaemia in Dialysis-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 Anemia in Pediatric Subjects with Chronic Kidney Disease

• IRAS ID

  55067

• Contact name

  N Webb

• Sponsor organisation

  AMAG Pharmaceuticals, Inc.

• Eudract number

  2010-019387-37

• Clinicaltrials.gov Identifier

  NCT01155375

• Research summary

  The purpose of this research study is to evaluate the experimental drug Feraheme™ Injection (referred to as “ferumoxytol” or “study drug”), to see how well it works for treating iron deficiency anaemia (IDA) in children with chronic kidney disease (CKD), how safe it is, and what side effects may occur. 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). In this study, improvement in iron deficiency will be compared between child ‘subjects who receive ferumoxytol injections, either 2 or 4 times, and child’ subjects who receive an oral iron supplement taken by mouth. All child’ subjects will receive iron therapy. Another purpose of the study is to see what happens to ferumoxytol in children’s bodies and how the body clears the drug from blood. This is called pharmacokinetics (PK). PK blood samples will be obtained from some ferumoxytol-treated child subjects in each age group and dose group of the study. The PK part of the study will only be done on a small number of child’ subjects and is optional.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  10/H1008/88

• Date of REC Opinion

  31 Jan 2011

• REC opinion

  Further Information Favourable Opinion