Maintenance Treatment of Iron Deficiency in IBD Patients

Inflammatory Bowel Disease Clinical Trial

— FER-IBD-MAIN  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00810004
• Other study ID #: FERGI-MAIN
• Status: Completed
• Phase: Phase 3
• First received: December 16, 2008
• Last updated: December 19, 2012
• Start date: February 2009
• Est. completion date: October 2010

Study information

• Verified date: December 2012
• Source: Vifor Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesRussia: Ministry of Health of the Russian FederationUkraine: State Pharmacological Center - Ministry of HealthAustria: Agency for Health and Food Safety
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 245
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Iron Deficiency

Intervention

Drug:
• Ferinject
Intravenous infusion of iron

Locations

Country	Name	City	State
Russian Federation	State Scientific Center of Coloproctology of RosMedTekhnolgy	Moscow

Sponsors (2)

Lead Sponsor	Collaborator
Vifor Inc.	Parexel

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of maintenance treatment of iron deficiency		8 months	No