NCT01290315

Intravenous Ferric Carboxymaltose vs IV Iron Sucrose or IV Iron Dextran in Treating Iron Deficiency Anemia in Women

A Randomized, Controlled Study to Investigate the Safety and Oxidative Stress Potential of Intravenous Ferric Carboxymaltose (FCM) vs. IV Iron Sucrose or IV Iron Dextran in Treating Iron Deficiency Anemia in Women

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: American Regent, Inc. · Industry
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare safety and the oxidative stress potential of two doses of an investigational IV iron, ferric carboxymaltose (FCM), compared to an equal single dose of IV iron sucrose or IV iron dextran in the treatment of Iron Deficiency Anemia (IDA) in female subjects.

Detailed description

This was a Phase 2a, open-label, multicenter, randomized study that compared the safety and oxidative stress potential of FCM vs. IV iron sucrose or IV iron dextran in female subjects with IDA. Subjects with a diagnosis of IDA who required iron supplementation met all inclusion and no exclusion criteria, and had given informed consent were randomized. The duration of the study for each subject was a maximum of 6 weeks. Eligible subjects were randomized in a 1:1 ratio to FCM (Group A) or IV iron sucrose or IV iron dextran (Group B). Group A subjects received a single undiluted dose of iron as FCM by a slow IV injection on Day 0. Cohort I received 500 mg and Cohort II received 750 mg. Group B subjects received a single dose of iron as IV iron sucrose or as IC iron dextran on Day 0. Cohort I receive 500 mg iron sucrose and Cohort II received 750 mg iron dextran. Iron dextran administration was preceded by a 25 mg test dose 1 hour prior to infusion. All subjects had laboratory assessments at Baseline, 2 hours post-infusion, 24 hours post-infusion, Day 7 (drawn at the same time of day \[within 4 hours\] as the 24-hour visit), and Day 30 (drawn at the same time of day \[within 4 hours\] as the the 24-hour visit). On Days 7 and 30, the safety evalutation for all subjects included treatment-emergent adverse event reporting, concomitant medication review, physical examination including vital signs, and laboratory assessments. Any subject who withdrew from the study received a follow-up phone call 30 days after they received study drug.

Conditions

• Iron Deficiency Anemia

Interventions

Type	Name	Description
DRUG	Ferric Carboxymaltose (FCM)	One 500 mg dose at 100 mg/minute (Cohort I) or 750 mg dose at 100 mg/minute (Cohort II)
DRUG	Iron Sucrose / Iron Dextran	One 500 mg dose of IV iron sucrose administered over 4 hours (Cohort I), or a 750 mg dose of IV iron dextran administered as a 25 mg test dose over 5 minutes followed by a 725 mg dose over 3 hours if no adverse reaction to test dose is observed after 60 minutes (Cohort II)

Timeline

• Start date: 2009-08-01
• Primary completion: 2013-03-01
• Completion: 2013-08-01
• First posted: 2011-02-07
• Last updated: 2018-02-08
• Results posted: 2018-02-08

Locations

1 site across 1 country: United States