Overview

This trial is active, not recruiting.

Condition iron deficiency anemia
Treatments ferric carboxymaltose (fcm), iron dextran injection
Phase phase 2
Sponsor Luitpold Pharmaceuticals
Start date August 2010
End date May 2011
Trial size 40 participants
Trial identifier NCT01307007, 1VIT08023

Summary

The primary objective of this study is to assess the safety of an investigational intravenous iron (ferric carboxymaltose [FCM]) or an equal dose of iron dextran and explore the mechanism of hypophosphatemia following administration of FCM or that of an equal dose of iron dextran when treating women with iron deficiency anemia due to heavy uterine bleeding (HUB).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
ferric carboxymaltose (fcm)
15 mg/kg up to a maximum of 1000 mg intravenous diluted in 250 cc normal saline solution administered over 15 minutes on Day 0
(Active Comparator)
iron dextran injection Dexferrum and Infed
Test dose of 25 mg administered over 5 minutes, if no reaction occurs then the remainder of the dose (15 mg/kg or 1000 mg including the test dose) will be administered as per investigator. The infusion must be given only when resuscitative techniques for the treatment of anaphylactic reactions are readily available.

Primary Outcomes

Measure
Changes in blood markers of phosphate and bone metabolism following intravenous (IV) administration of FCM in order to explore the mechanism of asymptomatic hypophosphatemia previously observed to follow administration of FCM.
time frame: Day 0, Day 1, Day 7, Day 14, and Day 35
Changes in urine markers of phosphate and bone metabolism following intravenous (IV) administration of FCM in order to explore the mechanism of asymptomatic hypophosphatemia previously observed to follow administration of FCM.
time frame: Day 0, Day 1, Day 7, Day 14, and Day 35

Secondary Outcomes

Measure
Proportion of subjects achieving a hemoglobin increase > or = to 2 g/dL.
time frame: Anytime between baseline and end of study or time of intervention
Percent of subjects with treatment-emergent adverse events.
time frame: Anytime after study drug infusion between baseline (Day 0) through end of study (Day 35) or 30 days after last dose of study drug (whichever is longer)
Occurrence of treatment-emergent serious adverse events.
time frame: Anytime after study drug infusion between baseline (Day 0) through end of study (Day 35) or 30 days after last dose of study drug (whichever is longer)
Occurrence of treatment-emergent potentially clinically significant (PCS) values for routine clinical laboratory tests.
time frame: Day 0 (baseline), Day 1 (24 hours), Day 7, Day 14, and Day 35 (end of study)
Occurrence of treatment-emergent PCS vital sign values.
time frame: Day 0 (baseline), Day 1 (24 hours), Day 7, Day 14, and Day 35 (end of study)
Change from baseline to highest hemoglobin.
time frame: Anytime between baseline (Day 0) and end of study or time of intervention
Change from baseline to highest ferritin.
time frame: Anytime between baseline (Day 0) and end of study or time of intervention
Change from baseline to highest TSAT.
time frame: Anytime between baseline (Day 0) and end of study or time of intervention

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Female subjects > or = to 18 years of age - History of Heavy Uterine Bleeding within the past 6 months - Screening visit central laboratory Hgb < 12 g/dL - Screening Visit ferritin < or = to 100 ng/mL or < or = to 300 when TSAT is < or = to 30% - Demonstrate the ability to understand the requirements of the study, willingness to abide by study restrictions and to return for the required assessments Exclusion Criteria: - Known hypersensitivity reaction to any component of ferric carboxymaltose or iron dextran - Previously randomized in a clinical study of ferric carboxymaltose - Requires dialysis for treatment of chronic kidney disease - Chronic kidney disease, marked by estimated glomerular filtration rate < 60 ml/min/1.73m squared - Previous kidney transplant - History of primary hypophosphatemic disorder - Hypophosphatemia < 2.6 mg/dl - No evidence of iron deficiency - During the 10 day period prior to screening has been treated with intravenous iron - During the 30 day period prior to screening or during the study period has or will be treated with erythropoiesis stimulating agents (ESA) in a regimen that is off label - During the 30 day period prior to screening or during the study period has or will be treated with a red blood cell transfusion, radiotherapy and/or chemotherapy - During the 30 day period prior to screening or during the study period has or will require a surgical procedure that necessitates general anesthesia - Any non-viral infection - Aspartate aminotransferase (AST) or Alanine Aminotransferase (ALT) at screening, as determined by central labs, greater than 1.5 times the upper limit of normal - Known positive hepatitis with evidence of active disease - Received an investigational drug within 30 days of screening - Alcohol or drug abuse within the past 6 months - Hemochromatosis or other iron storage disorders - Malignancy history within the past 5 years other than basal or squamous cell skin cancer - Any other laboratory abnormality, medical condition or psychiatric disorders which in the opinion of the investigator would put the subject's disease management at risk or may result in the subject being unable to comply with study requirements - Pregnant or sexually-active female subjects who are of childbearing potential and who are not willing to use an acceptable form of contraception - Untreated primary hyperparathyroidism - Untreated gastrointestinal malabsorption (e.g., sprue)

Additional Information

Official title A Randomized, Controlled Study to Investigate the Safety and Explore the Mechanism of Hypophosphatemia With Intravenous Ferric Carboxymaltose (FCM) Versus Iron Dextran in Women With Iron Deficiency Secondary to Heavy Uterine Bleeding
Trial information was received from ClinicalTrials.gov and was last updated in July 2013.
Information provided to ClinicalTrials.gov by Luitpold Pharmaceuticals.