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

October 5, 2021 updated by: Vifor Pharma

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

456

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
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
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vifor Pharma

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

August 24, 2007

First Submitted That Met QC Criteria

August 24, 2007

First Posted (Estimate)

August 27, 2007

Study Record Updates

Last Update Posted (Actual)

October 14, 2021

Last Update Submitted That Met QC Criteria

October 5, 2021

Last Verified

March 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FER-CARS-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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