Safety and Tolerability of Ferric Carboxymaltose (FCM) Versus Iron Dextran in Treating Iron Deficiency Anemia

The objective of this study is to evaluate the safety of FCM in patients with anemia who are not dialysis dependent.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Luitpold Pharmaceuticals

Norristown, Pennsylvania, 19403, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects ≥18 years of age and able to give informed consent
Iron deficiency is the primary etiology of anemia
History of intolerance or an unsatisfactory response to oral iron
Screening Visit central laboratory Hgb ≤11 g/dL
Screening Visit ferritin ≤100 ng/mL or ≤300 when TSAT was ≤30%

Exclusion criteria

Previous participation in a FCM trial
Known hypersensitivity reaction to FCM or iron dextran
Requires dialysis for treatment of chronic kidney disease
Current anemia not attributed to iron deficiency
Received IV iron, RBC transfusion(s), or antibiotics 10 days prior and during the screening phase
Anticipated need for surgery during the 30 day period prior to screening or during the study period
AST or ALT greater than 1.5 times the upper limit of normal
Received an investigational drug within 30 days of screening
Women who are breastfeeding
Pregnant or sexually-active females who are not willing to use an effective form of birth control

Treatment and study plan

ferric carboxymaltose

Drug

15 mg/kg up to a maximum of 750 mg at 100 mg per minute weekly to a maximum cumulative dose of 2,250 mg.

Iron Dextran

Drug

As determined by the investigator to a maximum cumulative dose of 2,250 mg.

Other names: Dexferrum, INFeD

Primary outcomes

The Number of Subjects Who Reported Treatment-emergent Adverse Events (AE's)

Time frame: Day 0 through end of study (Day 42), or 28 days after the last dose of study drug whichever was longer

Sponsors and collaborators

Lead sponsor

American Regent, Inc.

Industry

Registry information

Official study title

A Multi-Center, Randomized, Controlled Study to Investigate the Safety and Tolerability of Intravenous Ferric Carboxymaltose (FCM) vs. Iron Dextran in Treating Iron Deficiency Anemia

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2011
First posted: Jun 24, 2008
Registry last updated: Feb 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed