Maintenance Treatment of Iron Deficiency in IBD Patients

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00810004

Acronym

FER-IBD-MAIN

Enrollment

245

Registered

2008-12-17

Start date

2009-02-28

Completion date

2010-10-31

Last updated

2012-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory Bowel Disease, Iron Deficiency

Brief summary

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

Interventions

DRUGFerinject

Intravenous infusion of iron

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Efficacy of maintenance treatment of iron deficiency	8 months

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026