Clinical trial NCT01290315: Intravenous Ferric Carboxymaltose vs IV Iron Sucrose or IV Iron Dextran in Treating Iron Deficiency Anemia in Women
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Iron Deficiency Anemia
Lead sponsor: American Regent, Inc.
Sponsor class: INDUSTRY
First posted: 2011-02-07
Enrollment: 49
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 10 g/dL or \< or = to 12 g/dL with symptoms (dizziness and/or fatigue).
* Screening Visit ferritin \< or = to 100 ng/mL or \< or = to 300 when TSAT is \< or = to 30%.
* Documented unsatisfactory response or intolerance to oral iron.

Exclusion Criteria:

* Previous participation in a ferric carboxymaltose (FCM) clinical trial.
* Known hypersensitivity reaction to any component of ferric carboxymaltose, Venofer, or Dexferrum.
* History of drug allergy or any history of rheumatoid arthritis or other autoimmune diseases.
* Current anemia not attributed to iron deficiency.
* During the 10 day period prior to screening has been treated with antibiotics.
* During the 30 day period prior to screening or during the study period has or will be treated with erythropoiesis stimulating agents.
* Active malignancy within 5 years. Basal or squamous cell skin cancer is not exclusionary.
* During the 30 day period prior to screening or during the study period has or will require a surgical procedure that necessitates general anesthesia.
* Current (acute or chronic) infection other than viral upper respiratory tract infection.
* AST or ALT at screening greater than 1.5 times the upper limit of normal.
* Known positive hepatitis B with evidence of active hepatitis.
* Known positive HIV-1/HIV-2 antibodies (anti-HIV).
* Patient has an active diagnosis of asthma and is currently using an anti- asthmatic therapy.
* Received an investigational drug within 30 days of screening.
* Alcohol or drug abuse within the past 6 months.
* Hemochromatosis or other iron storage disorders.
* Systolic blood pressure \> or = to 180 or \< 80 mmHg or diastolic blood pressure \> 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.

Primary outcomes:
measure: Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)
timeFrame: Change from Baseline to Day 30
measure: Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)
timeFrame: Change from baseline to 2 hours post end IV infusion
measure: Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)
timeFrame: Change from baseline to 24 hours post end IV infusion
measure: Changes From Baseline in Markers of Oxidative Stress (Carbonyl and 8-isoprostane)
timeFrame: Change from baseline to Day 7 post end IV infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Norristown
country: United States
facility: Luitpold Pharmaceuticals, Inc.
state: Pennsylvania
Study officials:
affiliation: American Regent, Inc.
name: Linda M Mundy, MD, PhD
role: STUDY_DIRECTOR
References: