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

Purpose

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.

Condition	Intervention	Phase
Inflammatory Bowel Disease Anemia Iron Deficiency Iron-Deficiency Anemia Crohn's Disease Ulcerative Colitis	Drug: Ferric carboxymaltose Drug: Iron Sucrose	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease ulcerative colitis

MedlinePlus related topics: Anemia Crohn's Disease Iron Ulcerative Colitis

Drug Information available for: Sucrose

U.S. FDA Resources

Further study details as provided by Vifor Inc.:

Primary Outcome Measures:

Number of responders with respect to the baseline Hb value. [ Time Frame: 12 weeks post baseline ] [ Designated as safety issue: No ]
Number of responders (Hb increase ≥2 g/dL) with respect to the baseline Hb value.

Secondary Outcome Measures:

Number of patients whose Hb increased ≥2 g/dL or who reached normal Hb levels at Week 12. [ Time Frame: 12 weeks post baseline ] [ Designated as safety issue: No ]
The number of patients who achieved increase of Hb ≥2 g/dL or the normal range of Hb value of Hb ≥12 (female) or ≥13 (male) g/dL) at Week 12.
Change in disease activity (CDAI, CAI, C-reactive protein [CRP]). [ Time Frame: 12 weeks post baseline ] [ Designated as safety issue: Yes ]
Change in disease activity (Crohn's Disease Activity Index [CDAI], Colitis Activity Index [CAI], C-reactive protein [CRP]) at Week 12.
The number of patients at Week 12: TfS: 20 to 50%. [ Time Frame: 12 weeks post baseline ] [ Designated as safety issue: No ]
The number of patients at Week 12: TfS: 20 to 50%.
The number of non-anaemic patients at Week 12 [ Time Frame: Week 12 post baseline ] [ Designated as safety issue: No ]
The number of non-anaemic patients at Week 12: Hb ≥12 (female) or ≥13 (male) g/dL.
The number of patients with ferritin >100 µg/L at Week 12. [ Time Frame: 12 weeks post baseline ] [ Designated as safety issue: No ]
The number of patients with ferritin >100 µg/L at Week 12.
Maximum increase in Hb, serum ferritin and TfS. [ Time Frame: 12 weeks post baseline ] [ Designated as safety issue: No ]
Maximum increase in Hb, serum ferritin and TfS.
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 ] [ Designated as safety issue: No ]
The number of patients at Week 12: Hb ≥12 (female) or ≥13 (male) g/dL and ferritin >100 µg/L.
The number of patients withdrawal from study due to protocol procedure. [ Time Frame: 12 weeks post baseline ] [ Designated as safety issue: No ]
The number of patients withdrawal from study due to protocol procedure.
The number of responders (Hb increase ≥2 g/dL) with respect to treatment of underlying disease. [ Time Frame: 12 weeks post baseline ] [ Designated as safety issue: No ]
The number of responders (Hb increase ≥2 g/dL) with respect to treatment of underlying disease.
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 ] [ Designated as safety issue: No ]
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.
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 ] [ Designated as safety issue: No ]
Change in health-related quality of life (QoL) from baseline to Week 12 using the Short Form (SF)-36, version 2 and IBDQ.
The number of patients out of work due to anaemia or IBD. [ Time Frame: 12 weeks post baseline ] [ Designated as safety issue: No ]
The number of patients out of work due to anaemia or IBD.
Days out of hospital. [ Time Frame: 12 weeks post baseline ] [ Designated as safety issue: Yes ]
Days out of hospital.
Hospitalisation rate [ Time Frame: 12 weeks post baseline ] [ Designated as safety issue: Yes ]
Hospitalisation rate (hospitalisation due to anaemia and/or IBD).
Adverse events: type, nature, incidence and outcome. [ Time Frame: 12 weeks post baseline ] [ Designated as safety issue: Yes ]
Adverse events: type, nature, incidence and outcome.
Vital signs (blood pressure, pulse rate and bw). [ Time Frame: 12 weeks post baseline ] [ Designated as safety issue: Yes ]
Vital signs (blood pressure, pulse rate and bw).
Electrocardiogram. [ Time Frame: 12 weeks post baseline ] [ Designated as safety issue: Yes ]
Electrocardiogram.
Change in laboratory parameters (haematology, clinical chemistry, iron status, urinalysis). [ Time Frame: 12 weeks post baseline ] [ Designated as safety issue: Yes ]
Change in laboratory parameters (haematology, clinical chemistry, iron status, urinalysis).
Physical examination. [ Time Frame: 12 weeks post baseline ] [ Designated as safety issue: Yes ]
Physical examination.
The number of responders (Hb increase ≥2 g/dL) with respect to the baseline Hb value. [ Time Frame: 12 weeks post baseline ] [ Designated as safety issue: No ]
The number of responders (Hb increase ≥2 g/dL) with respect to the baseline Hb value.

Enrollment:	484
Study Start Date:	October 2008
Study Completion Date:	April 2010
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: FERINJECT® (Ferric carboxymaltose)	Drug: Ferric carboxymaltose 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 Other Name: FERINJECT®
Active Comparator: VENOFER® (Iron Sucrose)	Drug: Iron Sucrose 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. Other Name: VENOFER®

Arms

Assigned Interventions

Experimental: FERINJECT® (Ferric carboxymaltose)

Drug: Ferric carboxymaltose

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

Other Name: FERINJECT®

Active Comparator: VENOFER® (Iron Sucrose)

Drug: Iron Sucrose

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.

Other Name: VENOFER®

Show Detailed Description

Eligibility

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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00810030

Locations

Austria
AKH Vienna, University clinic of Int Medizin III
Vienna, Austria, 1090

Sponsors and Collaborators

Vifor Inc.

Parexel

ClinStar

Investigators

Principal Investigator:

Christoph Gasche, Professor

Medical University of Vienna

More Information

No publications provided

Responsible Party:	Vifor Inc.
ClinicalTrials.gov Identifier:	NCT00810030 History of Changes
Other Study ID Numbers:	FER-IBD-07-COR
Study First Received:	December 16, 2008
Last Updated:	December 19, 2012
Health Authority:	Russia: Ministry of Health of the Russian Federation Ukraine: State Pharmacological Center - Ministry of Health Austria: Federal Ministry for Health Family and Youth Denmark: The Ministry of the Interior and Health Estonia: The State Agency of Medicine France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Lithuania: State Medicine Control Agency - Ministry of Health Norway: Norwegian Institute of Public Health Romania: National Medicines Agency Spain: Ministry of Health Sweden: The National Board of Health and Welfare United Kingdom: Medicines and Healthcare Products Regulatory Agency Switzerland: Federal Office of Public Health

Keywords provided by Vifor Inc.:

ferric carboxymaltose
iron sucrose
Iron-Deficiency Anemia
Crohn's Disease

Ulcerative Colitis
Ferritin
Transferrin

Additional relevant MeSH terms:

Anemia
Anemia, Iron-Deficiency
Anemia, Hypochromic
Colitis
Colitis, Ulcerative
Crohn Disease
Inflammatory Bowel Diseases
Intestinal Diseases
Ulcer
Deficiency Diseases
Hematologic Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases

Pathologic Processes
Malnutrition
Nutrition Disorders
Iron Metabolism Disorders
Metabolic Diseases
Ferric oxide, saccharated
Ferric Compounds
Iron
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 19, 2013