Maintenance Treatment of Iron Deficiency in IBD Patients

Phase 3

Completed

• Conditions: Iron Deficiency; Inflammatory Bowel Disease
• Interventions: Drug: Ferinject

• Registration Number: NCT00810004
• Lead Sponsor: Vifor Pharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-12-16
• Study First Submitted QC: 2008-12-16
• Study First Posted: 2008-12-17
• Study Start: 2009-02
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-19
• Last Update Posted: 2012-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 245

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Ferinject	NaCL 0,9%
Ferinject	Ferinject	Intravenous infusion of iron

Primary Outcome Measures

Name	Time	Method
Efficacy of maintenance treatment of iron deficiency	8 months

Trial Locations

Locations (1)

State Scientific Center of Coloproctology of RosMedTekhnolgy; 🇷🇺 Moscow, Russian Federation