Maintenance Treatment of Iron Deficiency in IBD Patients

NCT00810004 | Completed Phase 3

• 1 other identifier: FERGI-MAIN
• Study Type: interventional
• Target: 245
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Iron Deficiency; Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

• Efficacy of maintenance treatment of iron deficiency

  8 months

Study Arms (2)

Ferinject

EXPERIMENTAL

Intravenous infusion of iron

Drug: Ferinject

Placebo

PLACEBO COMPARATOR

NaCL 0,9%

Drug: Ferinject

Interventions

Ferinject DRUG

Intravenous infusion of iron

Ferinject; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vifor Pharma: lead
• Parexel: collaborator

Study Sites (1)

State Scientific Center of Coloproctology of RosMedTekhnolgy

Moscow, 123423, Russia

Location

Related Publications (1)

• Evstatiev R, Alexeeva O, Bokemeyer B, Chopey I, Felder M, Gudehus M, Iqbal T, Khalif I, Marteau P, Stein J, Gasche C; FERGI Study Group. Ferric carboxymaltose prevents recurrence of anemia in patients with inflammatory bowel disease. Clin Gastroenterol Hepatol. 2013 Mar;11(3):269-77. doi: 10.1016/j.cgh.2012.10.013. Epub 2012 Oct 16.

  PMID: 23078888 DERIVED

MeSH Terms

Conditions

Iron Deficiencies; Inflammatory Bowel Diseases

Interventions

ferric carboxymaltose

Condition Hierarchy (Ancestors)

Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Christoph Gasche, Professor

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2008
• First Posted: December 17, 2008
• Study Start: February 1, 2009
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: December 21, 2012

Record last verified: 2012-12

Locations

RU (1)