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

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

MedlinePlus related topics:

Anemia Heart Failure

ChemIDplus related topics:

Sodium chloride Ferric carboxymaltose

U.S. FDA Resources

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

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 ]

Estimated Enrollment:	9
Study Start Date:	April 2007
Estimated Study Completion Date:	September 2008

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

Contacts


Contact: Claudio Mori, MD	+41 58 851 84 84	claudio.mori@vifor.com

Show 48 Study Locations

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

Study ID Numbers:	FER-CARS-02
First Received:	August 24, 2007
Last Updated:	April 4, 2008
ClinicalTrials.gov Identifier:	NCT00520780
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

Study placed in the following topic categories:

Heart Failure

Metabolic Diseases

Malnutrition

Heart Diseases

Hematologic Diseases

Anemia

Nutrition Disorders

Iron Metabolism Disorders

Metabolic disorder

Iron

Deficiency Diseases

Anemia, Iron-Deficiency

Additional relevant MeSH terms:

Anemia, Hypochromic

Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 20, 2008

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