Chronic Heart FailurePhase 3FAIR-HFNCT00520780
Ferinject® Assessment in Patients With Iron Deficiency and Chronic Heart Failure (FAIR-HF)
A Phase 3 study testing Ferinject ® (Ferric carboxymaltose) and Normal saline (0.9%) in people with Chronic Heart Failure and Iron Deficiency, run by Vifor Pharma at 48 sites in 10 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Heart Failure, Iron Deficiency, Iron Deficiency Anemia
- What is being tested?
- Ferinject ® (Ferric carboxymaltose) and Normal saline (0.9%)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 456 participants
- Where
- 48 sitesin 10 countries
- Study dates
- Apr 2007to Sep 2009
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%
Who cannot join
- 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.
Show all 9Show fewer
- 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.
Trial locations and contacts
48 sites in 10 countries.
48 sites in 10 countries
Poland11 sites
Research Site
Bialystok
Research Site
Krakow
Research Site
Opole
Research Site
Piotrkow Trybunalski
Research Site
Siedlce
Research Site
Torun
Research Site
Wałbrzych
Research Sites
Warsaw
Research Site
Włocławek
Research Site
Wroclaw
Research Site
Zabrze
Germany9 sites
Research Site
Bad Nauheim
Research Site
Berlin
Research Site
Göttingen
Research Site
Hanover
Research Sites
Heidelberg
Research Site
Herford
Research Site
Herne
Research Site
Kiel
Research Site
München
Ukraine8 sites
Research Site
Dnipropetrovsk
Research Site
Donetsk
Research Site
Kharkiv
Research Sites
Kiev
Research Site
Lviv
Research Site
Mykolayiv
Research Site
Odesa
Research Site
Zaporizhzhya
Spain5 sites
Research Site
Alicante
Research Sites
Barcelona
Research Site
Bilbao
Research Site
Madrid
Research Site
Valencia
Italy4 sites
Research Site
Ascoli Piceno
Research Site
Pavia
Research Site
Rome
Research Site
Vicenza
Romania4 sites
Research Site
Brasov
Research Sites
Bucharest
Reserach Site
Craiova
Research Sites
Târgu Mureş
Russia3 sites
Reserach Sites
Moscow
Resarch Sites
Saint Petersburg
Research Sites
Velikiy Novgorod
About this 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
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.
- Being tested
- Ferinject ® (Ferric carboxymaltose), Normal saline (0.9%)
- Keywords
- Chronic Heart Failure, Iron deficiency, Iron deficiency anaemia, Anaemia, Heart disease
- Medical subject headings
- Iron Deficiencies, Anemia, Iron-Deficiency, Anemia, Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferinject ® (Ferric carboxymaltose)Drug
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%)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Ferinject ® (Ferric carboxymaltose) |
| 2 | Placebo comparator | Not described Receives: Drug: Normal saline (0.9%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported patient global assessment (PGA) and NYHA functional status 24 weeks after initiation of therapy
Measured: 24 weeks
Secondary outcomes (1)
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
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2007 (estimated)
- Study startApr 2007
- Primary completionJul 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 456 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vifor Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Syneos Health, ClinStar, LLC
- Responsible party
- Sponsor
- Investigators
- Philip A Poole-Wilson, MD FRCP, Principal investigator, National Heart and Lung Institute. Faculty of Medicine. Imperial College London. Dovehouse Street, London SW3 6LY, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00520780
- Sponsor's protocol ID
- FER-CARS-02
- Acronym
- FAIR-HF
- Status last verified
- Mar 2010
- First submitted
- 24 Aug 2007
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Anker SD, Comin Colet J, Filippatos G, Willenheimer R, Dickstein K, Drexler H, Luscher TF, Bart B, Banasiak W, Niegowska J, Kirwan BA, Mori C, von Eisenhart Rothe B, Pocock SJ, Poole-Wilson PA, Ponikowski P; FAIR-HF Trial Investigators. Ferric carboxymaltose in patients with heart failure and iron deficiency. N Engl J Med. 2009 Dec 17;361(25):2436-48. doi: 10.1056/NEJMoa0908355. Epub 2009 Nov 17.
PubMed 19920054Anker SD, Colet JC, Filippatos G, Willenheimer R, Dickstein K, Drexler H, Luscher TF, Mori C, von Eisenhart Rothe B, Pocock S, Poole-Wilson PA, Ponikowski P; FAIR-HF committees and investigators. Rationale and design of Ferinject assessment in patients with IRon deficiency and chronic Heart Failure (FAIR-HF) study: a randomized, placebo-controlled study of intravenous iron supplementation in patients with and without anaemia. Eur J Heart Fail. 2009 Nov;11(11):1084-91. doi: 10.1093/eurjhf/hfp140.
PubMed 19875408
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00520780
- Acronym / sponsor ID
- FAIR-HF / FER-CARS-02
- Keywords
- Chronic Heart Failure, Iron deficiency, Iron deficiency anaemia, Anaemia, Heart disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 456 participants (actual)
- Lead sponsor
- Vifor PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Syneos Health, ClinStar, LLC
- Study start
- Apr 2007
- Primary completion
- Jul 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 27 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Ferinject ® (Ferric carboxymaltose) |
| 2 | Placebo comparator | Drug: Normal saline (0.9%) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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%
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Drug | 1 |
| 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. | Drug | 2 |
Primary outcome
Self-reported patient global assessment (PGA) and NYHA functional status 24 weeks after initiation of therapy
Time frame: 24 weeks
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Derived from this study: PubMed 19920054Anker SD, Comin Colet J, Filippatos G, Willenheimer R, Dickstein K, Drexler H, Luscher TF, Bart B, Banasiak W, Niegowska J, Kirwan BA, Mori C, von Eisenhart Rothe B, Pocock SJ, Poole-Wilson PA, Ponikowski P; FAIR-HF Trial Investigators. Ferric carboxymaltose in patients with heart failure and iron deficiency. N Engl J Med. 2009 Dec 17;361(25):2436-48. doi: 10.1056/NEJMoa0908355. Epub 2009 Nov 17.
- Derived from this study: PubMed 19875408Anker SD, Colet JC, Filippatos G, Willenheimer R, Dickstein K, Drexler H, Luscher TF, Mori C, von Eisenhart Rothe B, Pocock S, Poole-Wilson PA, Ponikowski P; FAIR-HF committees and investigators. Rationale and design of Ferinject assessment in patients with IRon deficiency and chronic Heart Failure (FAIR-HF) study: a randomized, placebo-controlled study of intravenous iron supplementation in patients with and without anaemia. Eur J Heart Fail. 2009 Nov;11(11):1084-91. doi: 10.1093/eurjhf/hfp140.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip A Poole-Wilson, MD FRCP principal investigator
National Heart and Lung Institute. Faculty of Medicine. Imperial College London. Dovehouse Street, London SW3 6LY, UK
48 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ferinject ® (Ferric carboxymaltose) and Normal saline (0.9%) in people with Chronic Heart Failure and Iron Deficiency, run by Vifor Pharma at 48 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in Poland, Germany, Ukraine, Spain, Italy and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported patient global assessment (PGA) and NYHA functional status 24 weeks after initiation of therapy (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00520780, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2021.