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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00810030
• Date of registration: 16/12/2008
• Prospective Registration: No
• Primary sponsor: Vifor Inc.
• Public title: FERINJECT for Correction of Anaemia in IBD Patients, FER-IBD-COR FER-IBD-COR
• Scientific title: Select A Multi-centre Randomised Prospective Open-label Study to Investigate the Efficacy & Safety of a Standardised Correction Dosage Regimen of i.v. Ferric Carboxymaltose Versus Iron Sucrose for Treatment of Iron Deficiency Anaemia in Patients With Inflammatory Bowel Disease
• Date of first enrolment: October 2008
• Target sample size: 484
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00810030
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Austria, Russian Federation

Contacts

• Name: Christoph Gasche, Professor
• Affiliation: Medical University of Vienna

Key inclusion & exclusion criteria

Inclusion Criteria

- 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.

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
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.

- 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Iron-Deficiency Anemia

Crohn's Disease

Inflammatory Bowel Disease

Iron Deficiency

Anemia

Ulcerative Colitis

Intervention(s)

Drug: Iron Sucrose

Drug: Ferric carboxymaltose

Primary Outcome(s)

Number of responders with respect to the baseline Hb value. [Time Frame: 12 weeks post baseline]

Secondary Outcome(s)

Hospitalisation rate [Time Frame: 12 weeks post baseline]

Number of patients whose Hb increased =2 g/dL or who reached normal Hb levels at Week 12. [Time Frame: 12 weeks post baseline]

The number of patients out of work due to anaemia or IBD. [Time Frame: 12 weeks post baseline]

The number of non-anaemic patients at Week 12 [Time Frame: Week 12 post baseline]

Physical examination. [Time Frame: 12 weeks post baseline]

The number of patients with ferritin >100 µg/L at Week 12. [Time Frame: 12 weeks post baseline]

The number of patients with Hb baseline value =10 g/dL who achieved Hb increase =2 g/dL and the number of patients with Hb baseline value >10 g/dL who achieved Hb increase =2 g/dL. [Time Frame: 12 weeks post baseline]

The number of patients at Week 12: TfS: 20 to 50%. [Time Frame: 12 weeks post baseline]

Adverse events: type, nature, incidence and outcome. [Time Frame: 12 weeks post baseline]

Days out of hospital. [Time Frame: 12 weeks post baseline]

Change in disease activity (CDAI, CAI, C-reactive protein [CRP]). [Time Frame: 12 weeks post baseline]

Change in health-related quality of life (QoL) from baseline to Week 12 using the Short Form (SF)-36, version 2 and IBDQ. [Time Frame: 12 weeks post baseline]

Electrocardiogram. [Time Frame: 12 weeks post baseline]

The number of responders (Hb increase =2 g/dL) with respect to treatment of underlying disease. [Time Frame: 12 weeks post baseline]

Change in laboratory parameters (haematology, clinical chemistry, iron status, urinalysis). [Time Frame: 12 weeks post baseline]

The number of responders (Hb increase =2 g/dL) with respect to the baseline Hb value. [Time Frame: 12 weeks post baseline]

Vital signs (blood pressure, pulse rate and bw). [Time Frame: 12 weeks post baseline]

Maximum increase in Hb, serum ferritin and TfS. [Time Frame: 12 weeks post baseline]

The number of patients at achieving Hb =12 (female) or =13 (male) g/dL and ferritin >100 µg/L at Week 12. [Time Frame: 12 weeks post baseline]

The number of patients withdrawal from study due to protocol procedure. [Time Frame: 12 weeks post baseline]

Secondary ID(s)

FER-IBD-07-COR

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Parexel

ClinStar