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

Chronic Heart Failure Clinical Trial

— FAIR-HF  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00520780
• Other study ID #: FER-CARS-02
• Status: Completed
• Phase: Phase 3
• Start date: April 2007
• Est. completion date: September 2009

Study information

• Verified date: March 2010
• Source: Vifor Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 456
• Est. completion date: September 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anaemia
• Anemia
• Anemia, Iron-Deficiency
• Chronic Heart Failure
• Heart Failure
• Iron Deficiency
• Iron Deficiency Anemia

Intervention

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).
• 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.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Vifor Pharma	ClinStar, LLC, Syneos Health

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported patient global assessment (PGA) and NYHA functional status 24 weeks after initiation of therapy		24 weeks
Secondary	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		24 weeks