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

Tracking Information

First Received Date ^ICMJE

August 24, 2007

Last Updated Date

October 15, 2009

Start Date ^ICMJE

April 2007

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00520780 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Chronic Heart Failure
Iron Deficiency
Iron Deficiency Anemia
Anaemia

Intervention ^ICMJE

Drug: Ferinject ® (Ferric carboxymaltose)
Drug: Normal saline (0.9%)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

456

Completion Date

September 2009

Primary Completion Date

July 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Argentina, Germany, Greece, Italy, Norway, Poland, Romania, Russian Federation, Spain, Ukraine

Administrative Information

NCT ID ^ICMJE

NCT00520780

Responsible Party

Study ID Numbers ^ICMJE

FER-CARS-02

Study Sponsor ^ICMJE

Vifor Inc.

Collaborators ^ICMJE

Kendle International
ClinStar

Investigators ^ICMJE

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

Information Provided By

Vifor Inc.

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP