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

Sponsor

Vifor Pharma (Industry)

Overall Status

Completed

CT.gov ID

NCT00520780

Collaborator

Syneos Health (Other), ClinStar, LLC (Industry)

456

Enrollment

Locations

Arms

Duration (Months)

9.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Heart Failure Iron Deficiency Iron Deficiency Anemia Anaemia	Drug: Ferinject ® (Ferric carboxymaltose) Drug: Normal saline (0.9%)	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

456 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Study Start Date :

Apr 1, 2007

Actual Primary Completion Date :

Jul 1, 2009

Actual Study Completion Date :

Sep 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	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).
Placebo Comparator: 2	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.

Arm

Intervention/Treatment

Experimental: 1

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).

Placebo Comparator: 2

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	Country
1	Research Sites	Buenos Aires	Argentina
2	Research Site	Bad Nauheim	Germany
3	Research Site	Berlin	Germany
4	Research Site	Göttingen	Germany
5	Research Site	Hannover	Germany
6	Research Sites	Heidelberg	Germany
7	Research Site	Herford	Germany
8	Research Site	Herne	Germany
9	Research Site	Kiel	Germany
10	Research Site	München	Germany
11	Research Site	Athens	Greece
12	Research Site	Heraklion	Greece
13	Research Site	Ascoli Piceno	Italy
14	Research Site	Pavia	Italy
15	Research Site	Rome	Italy
16	Research Site	Vicenza	Italy
17	Research Site	Stavanger	Norway
18	Research Site	Bialystok	Poland
19	Research Site	Krakow	Poland
20	Research Site	Opole	Poland
21	Research Site	Piotrkow Trybunalski	Poland
22	Research Site	Siedlce	Poland
23	Research Site	Torun	Poland
24	Research Site	Walbrzych	Poland
25	Research Sites	Warszawa	Poland
26	Research Site	Wloclawek	Poland
27	Research Site	Wroclaw	Poland
28	Research Site	Zabrze	Poland
29	Research Site	Brasov	Romania
30	Research Sites	Bucharest	Romania
31	Reserach Site	Craiova	Romania
32	Research Sites	Targu Mures	Romania
33	Reserach Sites	Moscow	Russian Federation
34	Research Sites	Novgorod	Russian Federation
35	Resarch Sites	St. Petersburg	Russian Federation
36	Research Site	Alicante	Spain
37	Research Sites	Barcelona	Spain
38	Research Site	Bilbao	Spain
39	Research Site	Madrid	Spain
40	Research Site	Valencia	Spain
41	Research Site	Dnipropetrovsk	Ukraine
42	Research Site	Donetsk	Ukraine
43	Research Site	Kharkiv	Ukraine
44	Research Sites	Kiev	Ukraine
45	Research Site	Lviv	Ukraine
46	Research Site	Mykolayiv	Ukraine
47	Research Site	Odessa	Ukraine
48	Research Site	Zaporozhye	Ukraine

Sponsors and Collaborators

Vifor Pharma
Syneos Health
ClinStar, LLC

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