Ferinject® Assessment in Patients With IRon Deficiency and Chronic Heart Failure (FAIR-HF) - Full Text View

Sponsor:	Vifor Inc.
Collaborators:	Kendle International ClinStar
Information provided by:	Vifor Inc.
ClinicalTrials.gov Identifier:	NCT00520780

Purpose

This study is designed to evaluate the efficacy of Ferinject® in improving symptoms of CHF in patients with iron deficiency. Analyses will focus both on subjective and objective measures. Furthermore, the tolerability and safety of Ferinject® treatment will be evaluated.

Condition	Intervention	Phase
Chronic Heart Failure Iron Deficiency Iron Deficiency Anemia Anaemia	Drug: Ferinject ® (Ferric carboxymaltose) Drug: Normal saline (0.9%)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomised Double-blind Controlled Phase III Study to Compare the Efficacy and Safety of Intravenous Iron Carboxymaltose (Ferinject®) With Placebo in Patients With Chronic Heart Failure and Iron Deficiency

Resource links provided by NLM:

MedlinePlus related topics: Anemia Heart Failure

Drug Information available for: Ferric carboxymaltose

U.S. FDA Resources

Further study details as provided by Vifor Inc.:

Primary Outcome Measures:

Self-reported patient global assessment (PGA) and NYHA functional status 24 weeks after initiation of therapy [ Time Frame: 24 weeks ]

Secondary Outcome Measures:

Key secondary objectives (efficacy): Exercise tolerance (6-minute walk test distance). Further secondary objectives(efficacy): Health related quality of life, resource use and costs associated with the treatment, safety and tolerability [ Time Frame: 24 weeks ]

Enrollment:	456
Study Start Date:	April 2007
Study Completion Date:	September 2009
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Ferinject ® (Ferric carboxymaltose) Ferinject® will be administered in doses of 200 mg (4 mL) weekly up to iron repletion (correction phase of variable duration depending on individual iron deficit). The calculated dose will be rounded to the next 100 mg iron, i.e. the final dose may be 100 mg iron depending on the individual iron deficit. After the correction phase, Ferinject® will be given monthly in doses of 200 mg until the 24th week (maintenance phase).
2: Placebo Comparator	Drug: Normal saline (0.9%) During the correction phase, patients will receive the number of normal saline injections (4 mL weekly) corresponding to the calculated total iron dose needed according to the individual iron deficit. During the maintenance phase, placebo patients will receive 4 mL normal saline monthly.

Arms

Assigned Interventions

1: Experimental

Drug: Ferinject ® (Ferric carboxymaltose)

Ferinject® will be administered in doses of 200 mg (4 mL) weekly up to iron repletion (correction phase of variable duration depending on individual iron deficit). The calculated dose will be rounded to the next 100 mg iron, i.e. the final dose may be 100 mg iron depending on the individual iron deficit.

After the correction phase, Ferinject® will be given monthly in doses of 200 mg until the 24th week (maintenance phase).

2: Placebo Comparator

Drug: Normal saline (0.9%)

During the correction phase, patients will receive the number of normal saline injections (4 mL weekly) corresponding to the calculated total iron dose needed according to the individual iron deficit. During the maintenance phase, placebo patients will receive 4 mL normal saline monthly.

Eligibility

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

Criteria

Inclusion Criteria:

In New York Heart Association (NYHA) II-III functional class due to stable symptomatic chronic heart failure (CHF)
Left ventricular ejection fraction (LVEF) 40% or lower for patients in NYHA II and 45% or lower in NYHA III
Screening haemoglobin (Hb) at least 9.5 g/dL but below or equal to 13.5 g/dL (average of 2 haemoglobin concentrations)
Screening ferritin below 100 µg/L, or below 300 µg/L when transferrin saturation (TSAT) is below 20%

Exclusion Criteria:

History of acquired iron overload.
Known active infection, clinically significant bleeding, active malignancy.
Chronic liver disease and/or screening alanine transaminase (ALT) or aspartate transaminase (AST)
Anaemia due to reasons other than iron deficiency
Immunosuppressive therapy or renal dialysis (current or planned within the next 6 months).
History of erythropoietin, i.v. or oral iron therapy, and blood transfusion in previous 12 weeks and/or such therapy planned within the next 6 months.
Unstable angina pectoris as judged by the investigator, clinically significant uncorrected valvular disease or left ventricular outflow obstruction, obstructive cardiomyopathy, poorly controlled fast atrial fibrillation or flutter, poorly controlled symptomatic brady- or tachyarrhythmias.
Acute myocardial infarction or acute coronary syndrome, transient ischaemic attack or stroke within the last 3 months.
Coronary-artery bypass graft, percutaneous intervention (e.g. cardiac, cerebrovascular, aortic; diagnostic catheters are allowed) or major surgery, including thoracic and cardiac surgery, within the last 3 months.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00520780

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Locations

Argentina
Research Sites
Buenos Aires, Argentina
Germany
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Berlin, Germany
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Herne, Germany
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München, Germany
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Bad Neuheim, Germany
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Kiel, Germany
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Heidelberg, Germany
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Göttingen, Germany
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Hannover, Germany
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Herford, Germany
Greece
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Athens, Greece
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Heraklion, Greece
Italy
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Rome, Italy
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Ascoli, Italy
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Pavia, Italy
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Vicenza, Italy
Norway
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Stavanger, Norway
Poland
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Wroclaw, Poland
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Piotrkow Trybunalski, Poland
Research Sites
Warszawa, Poland
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Torun, Poland
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Siedlce, Poland
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Bialystok, Poland
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Wloclawek, Poland
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Krakow, Poland
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Opole, Poland
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Zabrze, Poland
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Walbrzych, Poland
Romania
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Bucharest, Romania
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Targu Mures, Romania
Reserach Site
Craiova, Romania
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Brasov, Romania
Russian Federation
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Novgorod, Russian Federation
Reserach Sites
Moscow, Russian Federation
Resarch Sites
St. Petersburg, Russian Federation
Spain
Research Sites
Barcelona, Spain
Research Site
Valencia, Spain
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Madrid, Spain
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Alicante, Spain
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Bilbao, Spain
Ukraine
Research Sites
Kiev, Ukraine
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Donetsk, Ukraine
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Zaporozhye, Ukraine
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Mykolayiv, Ukraine
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Lviv, Ukraine
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Odessa, Ukraine
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Kharkiv, Ukraine
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Dnipropetrovsk, Ukraine

Sponsors and Collaborators

Vifor Inc.

Kendle International

ClinStar

Investigators

Principal Investigator:

Philip A Poole-Wilson, MD FRCP

National Heart and Lung Institute. Faculty of Medicine. Imperial College London. Dovehouse Street, London SW3 6LY, UK

More Information

No publications provided

Study ID Numbers:	FER-CARS-02
Study First Received:	August 24, 2007
Last Updated:	October 15, 2009
ClinicalTrials.gov Identifier:	NCT00520780 History of Changes
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Czech Republic: State Institute for Drug Control; European Union: European Medicines Agency; Germany: Federal Institute for Drugs and Medical Devices; Greece: National Drug Organization.; Italy: National Institute of Health ("Istituto Superiore di Sanità - I.S.S."); Italy: The Italian Medicines Agency ("Agenzia Italiana del Farmaco - A.I.F.A."); Norway: Norwegian Medicines Agency; Poland: Ministry of Health; Russia: Ministry of Health and Social Development of the Russian Federation; Romania: National Medicines Agency; Spain: Spanish Agency of Medicines; Sweden: Medical Products Agency; Switzerland: Swissmedic; Ukraine: Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agenc

Keywords provided by Vifor Inc.:

Chronic Heart Failure
Iron deficiency
Iron deficiency anaemia
Anaemia
Heart disease

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Metabolic Diseases
Hematologic Diseases
Growth Substances
Physiological Effects of Drugs
Anemia
Anemia, Hypochromic
Trace Elements

Iron Metabolism Disorders
Pharmacologic Actions
Anemia, Iron-Deficiency
Malnutrition
Nutrition Disorders
Cardiovascular Diseases
Micronutrients
Iron
Deficiency Diseases

ClinicalTrials.gov processed this record on November 27, 2009