Maintenance Treatment of Iron Deficiency in IBD Patients

Study Overview
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Brief Summary
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The aim of this study is to evaluate the treatment of iron deficiency in IBD patients.

Official Title
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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
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Iron Deficiency, Inflammatory Bowel Disease

Intervention / Treatment
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* Drug: Ferinject


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Non-anaemic patients treated in the FERGI-CORRECTION study (Hb ≥12 g/dL female, ≥13 g/dL male), independent of ferritin value. 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. Exclusion 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ferinject<br>Intravenous infusion of iron | Drug: Ferinject<br>* Intravenous infusion of iron<br>|
| Placebo Comparator: Placebo<br>NaCL 0,9% | Drug: Ferinject<br>* Intravenous infusion of iron<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of maintenance treatment of iron deficiency |  | 8 months |