Status:
COMPLETED
Maintenance Treatment of Iron Deficiency in IBD Patients
Lead Sponsor:
Vifor Pharma
Collaborating Sponsors:
Parexel
Conditions:
Iron Deficiency
Inflammatory Bowel Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The aim of this study is to evaluate the treatment of iron deficiency in IBD patients.
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
245 Patients enrolled
Trial Details
Trial ID
NCT00810004
Start Date
February 1 2009
End Date
October 1 2010
Last Update
December 21 2012
Active Locations (1)
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1
State Scientific Center of Coloproctology of RosMedTekhnolgy
Moscow, Russia, 123423