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

This study has been completed.
Sponsor:
Collaborator:
Parexel
Information provided by (Responsible Party):
Vifor Inc.
ClinicalTrials.gov Identifier:
NCT00810004
First received: December 16, 2008
Last updated: December 19, 2012
Last verified: December 2012
  Purpose

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

  Eligibility

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

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00810004

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

No publications provided by Vifor Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Vifor Inc.
ClinicalTrials.gov 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:
Inflammatory Bowel Diseases
Intestinal Diseases
Anemia, Iron-Deficiency
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 20, 2014