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

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: EUCTR2008-002333-75-AT

Lead Sponsor: Vifor (International) Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 420

Inclusion Criteria

Patients will be entered into this study only if they meet all of the following criteria:
• Signed informed consent.
• Patients =18 years of age suffering from mild IBD (CD/UC) or in remission (mild IBD defined as CDAI score <220, or CAI score =7, remission defined as CDAI score <150, or CAI score =4).
• Hb 7-12 g/dL (female) or 7-13 g/dL (male).
• Ferritin <100 µg/L.
• Normal levels of vitamin B12 and folic acid.
• 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 4 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 last 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 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 non-inferiority in efficacy of a standardised dosage regimen of FERINJECT® compared to individually calculated dosage regimens of VENOFER® in the correction of IDA in patients with IBD in remission.;Secondary Objective: To evaluate the safety and tolerability of a standardised correction dose regimen of FERINJECT®.;Primary end point(s): Number of responders (Hb increase =2 g/dL) at Week 12.

Secondary Outcome Measures