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

NCT00520780 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 456

Last updated 2021-10-14

No results posted yet for this study

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.

Conditions

Interventions

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).

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.

Sponsors & Collaborators

  • Syneos Health

    collaborator OTHER

  • ClinStar, LLC

    collaborator INDUSTRY

  • Vifor Pharma

    lead INDUSTRY

Principal Investigators

  • Philip A Poole-Wilson, MD FRCP · National Heart and Lung Institute. Faculty of Medicine. Imperial College London. Dovehouse Street, London SW3 6LY, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2009-07-31
Completion
2009-09-30

Countries

  • Argentina
  • Germany
  • Greece
  • Italy
  • Norway
  • Poland
  • Romania
  • Russia
  • Spain
  • Ukraine

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00520780 on ClinicalTrials.gov