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Hypophosphatemia With Intravenous Ferric Carboxymaltose Versus Iron Dextran in Women With Iron Deficiency Secondary to Heavy Uterine Bleeding

Information source: Luitpold Pharmaceuticals
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Iron Deficiency Anemia

Intervention: Ferric Carboxymaltose (FCM) (Drug); Iron Dextran Injection (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Luitpold Pharmaceuticals

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).

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

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.

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.

Secondary outcome:

Proportion of subjects achieving a hemoglobin increase > or = to 2 g/dL.

Percent of subjects with treatment-emergent adverse events.

Occurrence of treatment-emergent serious adverse events.

Occurrence of treatment-emergent potentially clinically significant (PCS) values for routine clinical laboratory tests.

Occurrence of treatment-emergent PCS vital sign values.

Change from baseline to highest hemoglobin.

Change from baseline to highest ferritin.

Change from baseline to highest TSAT.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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)

Locations and Contacts

Luitpold Pharmaceuticals, Inc., Norristown, Pennsylvania 19403, United States
Additional Information

Starting date: August 2010
Last updated: July 1, 2013

Page last updated: August 23, 2015

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