Maintenance Treatment of Iron Deficiency in IBD Patients (FER-IBD-MAIN)

This study has been completed.
Information provided by (Responsible Party):
Vifor Inc. Identifier:
First received: December 16, 2008
Last updated: December 19, 2012
Last verified: December 2012
The aim of this study is to evaluate the treatment of iron deficiency in IBD patients.

Condition Intervention Phase
Iron Deficiency
Inflammatory Bowel Disease
Drug: Ferinject
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Vifor Inc.:

Primary Outcome Measures:
  • Efficacy of maintenance treatment of iron deficiency [ Time Frame: 8 months ] [ Designated as safety issue: No ]

Enrollment: 245
Study Start Date: February 2009
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ferinject
Intravenous infusion of iron
Drug: Ferinject
Intravenous infusion of iron
Placebo Comparator: Placebo
NaCL 0,9%
Drug: Ferinject
Intravenous infusion of iron


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.

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Please refer to this study by its identifier: NCT00810004

Russian Federation
State Scientific Center of Coloproctology of RosMedTekhnolgy
Moscow, Russian Federation, 123423
Sponsors and Collaborators
Vifor Inc.
Principal Investigator: Christoph Gasche, Professor Medical University of Vienna
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Vifor Inc. Identifier: NCT00810004     History of Changes
Other Study ID Numbers: FERGI-MAIN 
Study First Received: December 16, 2008
Last Updated: December 19, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Russia: Ministry of Health of the Russian Federation
Ukraine: State Pharmacological Center - Ministry of Health
Austria: Agency for Health and Food Safety

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Inflammatory Bowel Diseases
Intestinal Diseases
Anemia, Hypochromic
Digestive System Diseases
Gastrointestinal Diseases
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases processed this record on May 26, 2016