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

Vifor

Status and phase

Completed

Phase 3

Conditions

Iron Deficiency

Inflammatory Bowel Disease

Treatments

Drug: Ferinject

Study type

Interventional

Funder types

Industry

Identifiers

NCT00810004

FERGI-MAIN

Details and patient eligibility

About

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

Enrollment

245 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.