FERINJECT for maintenance treatment of iron deficiency in IBD patients

• Research type

  Research Study

• Full title

  A multi-centre, randomised, prospective, single-blinded, controlled study to investigate the efficacy and safety of a standardised maintenance dosage regimen of intravenous ferric carboxymaltose (FERINJECT®) versus placebo in patients with iron deficiency caused by inflammatory bowel disease - The Maintenance Study

• IRAS ID

  4710

• Sponsor organisation

  Vifor France S.A.

• Eudract number

  2008-003591-22

• Research summary

  Iron deficiency is characterised by low levels of iron and decreased haemoglobin production (haemoglobin is the protein in red blood cells that carries oxygen). It??s a common complication of patients with inflammatory bowel disease (IBD) .Oral iron therapy is the first choice, however, its effectiveness in some patients can be reduced due to gastrointestinal bleeding or lack of absorption. In addition, it??s commonly associated with gastrointestinal adverse reactions.The purpose of this study is to evaluate the safety and effectiveness of maintenance treatment with FERINJECT© (an iron compound solution in water injected into the vein intravenously) on preventing a drop of iron levels. Only patients who were involved in a previous study which compared a new dose regimen of FERINJECT© to VENOFER© (another iron compound solution in water injected into the vein intravenously) and who do not have iron deficiency anaemia after the treatment in the first study, will be able to participate in this study. Around 200 patients from 135 centres in various European countries will be recruited. The patients will be randomized to one of two groups: Group 1 - FERINJECT© infusion. Group 2 - infusion with placebo (an inactive drug) The patients will come to the study centre 2, 4, 6, and 8 months after an initial baseline visit. If the patients have Ferritin drop below the normal range (what indicates iron deficiency), at any visit, they will receive a FERINJECT© or a placebo infusion (depending on the group they belong to). They will participate in this study for up to 8 months. In addition during the study the patient will undergo physical examination, measurement of heart rate, blood pressure, body temperature, height and weight samples of blood and urine, a diary to record the symptoms of their bowel disease and questionnaires about well-being and IBD.

• REC name

  North West - Greater Manchester Central Research Ethics Committee

• REC reference

  08/H1008/194

• Date of REC Opinion

  18 Feb 2009

• REC opinion

  Further Information Favourable Opinion