NCT03037931

Randomized Placebo-controlled Trial of FCM as Treatment for Heart Failure With Iron Deficiency / and Sub-Study

A Randomized, Double-Blind, Placebo- Controlled Study to Investigate the Efficacy and Safety of Injectafer® (Ferric Carboxymaltose) as Treatment for Heart Failure With Iron Deficiency /and Sub-Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,065 (actual)
• Sponsor: American Regent, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to determine the efficacy and safety of iron therapy using intravenous (IV) ferric carboxymaltose (FCM), relative to placebo in the treatment of participants in heart failure with a reduced ejection fraction and with iron deficiency

Detailed description

This is a double-blind, multicenter, prospective, randomized, placebo-controlled study to assess the effects of IV FCM compared to placebo on the 12-month rate of death, hospitalization for worsening heart failure, and the 6-month change in 6 minute walk test (6MWT) distance for patients in heart failure with iron deficiency. After an initial screening period of up to 28 days, eligible participants will be stratified by region and randomized in a 1:1 ratio to FCM or placebo for treatment. Study drug administration will occur on Day 0 and Day 7 (±2) as an undiluted slow IV push, with additional study visits planned at 3 month intervals, and additional dosing administered every 6 months as applicable. In a subset of sites, a sub-study will be conducted to characterize serum phosphate levels over time in participants with heart failure and iron deficiency after dosing with FCM. For all participants, hematology, ferritin, and transferrin saturation (TSAT), with appropriate safety evaluations, to determine additional treatment, will occur at 6 month intervals.

Conditions

• Heart Failure
• Iron-deficiency

Interventions

Type	Name	Description
DRUG	Ferric Carboxymaltose	Intravenous Iron
DRUG	Placebo	Normal Saline Solution

Timeline

• Start date: 2017-03-15
• Primary completion: 2023-02-02
• Completion: 2023-02-02
• First posted: 2017-01-31
• Last updated: 2024-07-03
• Results posted: 2024-07-03

Locations

345 sites across 13 countries: United States, Australia, Bulgaria, Canada, Czechia, Georgia, Hungary, Latvia, Lithuania, New Zealand, Poland, Russia, Ukraine

Regulatory

• FDA-regulated drug study