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

• Conditions: Iron deficiency anaemia in patients with inflammatory bowel disease; MedDRA version: 9.1Level: LLTClassification code 10055736Term: Iron deficiency anaemia secondary to blood loss (chronic)

• Registration Number: EUCTR2008-003591-22-GB
• Lead Sponsor: Vifor (International) Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-17
• Last Update Posted: 12 June 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Patients will be entered into this study only if they meet all of the following criteria:
•Signed informed consent.
•Non-anaemic patients treated in the FERGI CORRECTION study (Hb =12 g/dL female, =13 g/dL male), independent of ferritin value.
• If VitB12/folate levels are below normal range, an appropriate supplementation should be started.
•Females of child-bearing potential must have a negative urine pregnancy test at screening and be practising an acceptable method of birth control during the study and for up to 1 month after the last dose of study medication.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients will not be entered into this study if they meet any of the following criteria:
•Chronic alcohol abuse (alcohol consumption >20 g/day).
•Presence of portal hypertension with oesophageal varices.
•History of erythropoietin, intravenous or oral iron therapy, or blood transfusion in 12 weeks prior to screening.
•Known hypersensitivity to FERINJECT®.
•History of acquired iron overload.
•Myelodysplastic syndrome.
•Pregnancy or lactation.
•Known active infection, clinically significant overt bleeding, active malignancy.
•Known chronic renal failure.
•Surgery with relevant blood loss (defined as Hb drop <2 g/dL) in the 3 months prior to screening or planned surgery within the following 3 months.
•Chronic liver disease or increase of liver enzymes (alanine aminotransferase ([ALT], aspartate aminotransferase [AST]) >3 times the upper limit of normal range.
•Known human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS), hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
•Inability to fully comprehend and/or perform study procedures in the investigator’s opinion.
•Participation in any other interventional study (except correction study) within 1 month prior to screening.
•Body weight <35 kg.
•Significant cardiovascular disease, including myocardial infarction within 12 months prior to study inclusion, congestive heart failure NYHA (New York Heart Association) grade III or IV, or poorly controlled hypertension according to the judgment of the investigator.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy and safety of a standardised maintenance dosage regimen of FERINJECT® versus placebo in the correction of iron deficiency and prevention of anaemia in treatment over 8 months.;Secondary Objective: •To evaluate the efficacy of treatment with FERINJECT® in respect to health related Quality of Life (QoL) over 8 months.<br>•To evaluate the safety and tolerability of a standardised maintenance dosage regimen of FERINJECT®.<br>•To evaluate the effect of treatment with FERINJECT® over 8 months on the developing of underlying disease.<br>;Primary end point(s): Time to development of anaemia (Hb <12 g/dL [female], <13 g/dL [male]) in 8 months after randomisation – difference between the treatment groups.