Phase 2 N=49 Randomized Treatment

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

Iron Deficiency Anemia

Bottom Line

View on ClinicalTrials.gov: NCT01290315 ↗

Enrolled (actual)

Serious AEs

4.1%

Results posted

Feb 2018

Primary outcome: Primary: Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane) — -11.90; -1.06; -12.37; -11.14 mg

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Ferric Carboxymaltose (FCM) (Drug); Iron Sucrose / Iron Dextran (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: American Regent, Inc.
Primary completion: Mar 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)	11.69; -24.03; -18.20; -12.10; 263.52; -417.89	—
PRIMARY Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)	11.69; -24.03; -18.20; -12.10; 263.52; -417.89	—
PRIMARY Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)	11.69; -24.03; -18.20; -12.10; 263.52; -417.89	—
PRIMARY Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)	11.69; -24.03; -18.20; -12.10; 263.52; -417.89	—

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.

Eligibility Criteria

Inclusion Criteria

Female subjects 18-50 years of age and able to give informed consent.
If post-partum, at least 10 days post delivery at Day 0.
Screening Visit local laboratory Hgb or = to 180 or or = to 100 or < 40 mmHg at screening or Day 0.
Chronic kidney disease.
Chronic inflammatory condition including but not limited to Lupus and Rheumatoid Arthritis.
Pre-term delivery < 32 weeks.
Emergent C-section delivery.
Significant cardiovascular disease, including but not limited to myocardial infarction or unstable angina within 6 months prior to study inclusion or current history of NYHA Class III or IV congestive heart failure.
Any other laboratory abnormality, medical condition or psychiatric disorder which in the opinion of the investigator puts the subject's disease management at risk or may result in the subject being unable to comply with study requirements.
Night shift workers.
Breastfeeding planned on or after Day 0.
Pregnant or sexually-active female subjects who are of childbearing potential and who don't use an acceptable form of contraception.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01290315). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.