FERINJECT for Correction of Anaemia in IBD Patients, FER-IBD-COR

NCT00810030 | Completed Phase 3

• 1 other identifier: FER-IBD-07-COR
• Study Type: interventional
• Target: 484
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine how safe, tolerable and effective the new standardised dosage regimen of FERINJECT® infusions is, compared with a well established intravenous iron treatment.

Conditions

Inflammatory Bowel Disease; Anemia; Iron Deficiency; Iron-Deficiency Anemia; Crohn's Disease; Ulcerative Colitis

Keywords

ferric carboxymaltose; iron sucrose; Iron-Deficiency Anemia; Crohn's Disease; Ulcerative Colitis; Ferritin; Transferrin

Outcome Measures

Primary Outcomes (1)

• Number of responders with respect to the baseline Hb value.

  Number of responders (Hb increase ≥2 g/dL) with respect to the baseline Hb value.

  12 weeks post baseline

Secondary Outcomes (20)

• Number of patients whose Hb increased ≥2 g/dL or who reached normal Hb levels at Week 12.

  12 weeks post baseline

• Change in disease activity (CDAI, CAI, C-reactive protein [CRP]).

  12 weeks post baseline

• The number of patients at Week 12: TfS: 20 to 50%.

  12 weeks post baseline

• The number of non-anaemic patients at Week 12

  Week 12 post baseline

• The number of patients with ferritin >100 µg/L at Week 12.

  12 weeks post baseline

Study Arms (2)

FERINJECT® (Ferric carboxymaltose)

EXPERIMENTAL

Drug: Ferric carboxymaltose

VENOFER® (Iron Sucrose)

ACTIVE COMPARATOR

Drug: Iron Sucrose

Interventions

Ferric carboxymaltose DRUG

Dosage form: 5% w/v iron containing 50 mg iron per mL, as sterile solution of FERINJECT® in water for injection. In case of drip infusion FERINJECT® (10 to 20 ml) must be diluted only in sterile 0.9% sodium chloride (max 250 ml) FERINJECT® will be administered via i.v. drip infusion. Minimum administration time 15 minutes Dosage: 500 mg, 1000 mg, 1500 mg, according to patients' Hb and body weight

Also known as: FERINJECT®

FERINJECT® (Ferric carboxymaltose)

Iron Sucrose DRUG

VENOFER® will be administered via i.v. drip infusion, diluted only in sterile 0.9% sodium chloride solution as follows: • 10 mL Venofer® (200 mg iron) in maximum 200 mL sterile 0.9% sodium chloride solution in at least 30 minutes. The first 25 mL of solution should be infused as a test dose over a period of 15 minutes. If no adverse reactions occur, use infusion rate no more than 50 mL in 15 minutes. The individual iron deficit will be calculated using the modified formula of Ganzoni. If the patient's body mass index is \>25, a normalised weight will be used for the calculation of iron deficit. Normalised weight = 25 x height \[m\] x height \[m\]. The calculated cumulative VENOFER® dose is to be rounded up or down to the nearest 200 mg. Patients will receive one 200 mg VENOFER® infusion, twice a week, up to 11 times (max dosage 2200 mg), depending on their calculated iron deficit.

Also known as: VENOFER®

VENOFER® (Iron Sucrose)

Eligibility Criteria

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

You may qualify if:

• Signed informed consent.
• Patients ≥18 years of age suffering from mild IBD (CD/UC) or in remission (mild IBD defined as CDAI score \<220, or CAI score ≤7, remission defined as CDAI score \<150, or CAI score ≤4).
• Hb 7-12 g/dL (female) or 7-13 g/dL (male).
• Ferritin \<100 μg/L.
• Normal levels of vitamin B12 and folic acid.
• 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 4 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. Vifor Pharma - Vifor (International) Inc Clinical Study Protocol inc. Amendments 1 and 2 Protocol Number: 93842, FER-IBD-07-COR CONFIDENTIAL Final 20 of 48 10 December 2008
• Surgery with relevant blood loss (defined as Hb drop \<2 g/dL) in the last 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 within 1 month prior to screening.
• Body weight \<35 kg.

Sponsors & Collaborators

• Vifor Pharma: lead
• Parexel: collaborator
• ClinStar, LLC: collaborator

Study Sites (1)

AKH Vienna, University clinic of Int Medizin III

Vienna, 1090, Austria

Location

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Anemia; Iron Deficiencies; Anemia, Iron-Deficiency; Crohn Disease; Colitis, Ulcerative

Interventions

ferric carboxymaltose; Ferric Oxide, Saccharated

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Iron Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Anemia, Hypochromic; Colitis; Colonic Diseases

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Glucaric Acid; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Christoph Gasche, Professor

  Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• 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: October 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: April 1, 2010
• Last Updated: December 21, 2012

Record last verified: 2012-12

Locations

AU (1)