NCT01453608
Completed
Phase 4
A Randomised, Double-blind Controlled Phase 4 Study to Compare the Efficacy and Safety of Intravenous Ferric Carboxymaltose With Placebo in Patients With Chronic Heart Failure and Iron Deficiency
Vifor Pharma2 sites in 2 countries304 target enrollmentStarted: October 2011Last updated:
Overview
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Vifor Pharma
- Enrollment
- 304
- Locations
- 2
- Primary Endpoint
- Change in six minute walk test from baseline to week 24
Overview
Brief Summary
The purpose of this study is to determine, relative to placebo, the effect of iron repletion therapy using intravenous (IV) ferric carboxymaltose on exercise capacity in patients with chronic heart failure and iron deficiency.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Iron deficient subjects with stable chronic heart failure (CHF) (NYHA II-III) on optimal background therapy for CHF
- •Reduced left ventricular ejection fraction
- •Capable of completing 6 minute walk test
- •At least 18 years of age and with written informed consent prior to any study specific procedures
Exclusion Criteria
- •Erythropoietin stimulating agent (ESA) use, IV iron therapy and/or blood transfusion in previous 6 weeks prior to randomisation
- •Exercise training program(s) in the 3 months prior to screening or planned in the next 6 months
- •Chronic liver disease and/or elevated liver enzymes
- •Vitamin B12 and/or serum folate deficiency
- •Subject is not using adequate contraceptive precautions during the study
- •Body weight ≤ 35 kg
- •No other significant cardiac or general disorders that would compromise the ability to give informed consent and/or comply with study procedures
Arms & Interventions
Ferinject (ferric carboxymaltose)
Experimental
Intervention: Ferinject (ferric carboxymaltose) (Drug)
Placebo (saline)
Placebo Comparator
Intervention: Placebo (saline) (Drug)
Outcomes
Primary Outcomes
Change in six minute walk test from baseline to week 24
Time Frame: 24 weeks
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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