FERINJECT for Correction of Anaemia in IBD patients (Correction Study)

• Research type

  Research Study

• Full title

  A multi-centre, randomised, prospective, open-label study to investigate the efficacy and safety of a standardised correction dosage regimen of intravenous ferric carboxymaltose (FERINJECT®) versus iron sucrose (VENOFER®) for treatment of iron deficiency anaemia in patients with inflammatory bowel disease

• IRAS ID

  4709

• Sponsor organisation

  Vifor France S.A.

• Eudract number

  2008-002333-75

• Research summary

  Iron deficiency anaemia (IDA) is characterised by low levels of iron and decreased haemoglobin production (haemoglobin is the protein in red blood cells that carries oxygen) and is a common complication of patients suffering from inflammatory bowel disease (IBD). Oral iron therapy is the first choice in most patients with IDA. However its effectiveness in some patients can be reduced due to gastrointestinal bleeding and lack of absorption. In addition, oral iron therapy is commonly associated with gastrointestinal adverse reactions and in some cases may increase disease activity through the damage of intestinal mucosa (the innermost lining of the intestine)This study aims to assess how safe and effective a new dose regimen of iron compound called FERINJECT© is when compared to the standard treatment called VENOFER© Both FERINJECT© and VENOFER© are iron compounds in a solution of water, and should be injected into the vein (intravenously).Around 420 patients from 135 centres in various European countries will be recruited into this study, randomly assigned to either - FERINJECT© infusions or, - VENOFER© infusions In addition to screening and baseline visits, the patients will be required to attend the study centre again at 1, 2, 4, 8, and 12 weeks and are expected to participate in this study for up to 14 weeks. During the study the patient will undergo the following procedures: - physical examination. - measurement of heart rate, blood pressure, body temperature, height and weight. - samples of blood and urine taken for testing. - ECG - a test to measure the electrical activity of the heart - a diary to record the symptoms of their bowel disease. - questionnaires about their well-being and their IBD.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  08/H1008/193

• Date of REC Opinion

  18 Feb 2009

• REC opinion

  Further Information Favourable Opinion