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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01307007
First received: October 4, 2010
Last updated: July 1, 2013
Last verified: July 2013
  Purpose

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).


Condition Intervention Phase
Iron Deficiency Anemia
Drug: Ferric Carboxymaltose (FCM)
Drug: Iron Dextran Injection
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Luitpold Pharmaceuticals:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Blood markers include phosphate, calcium, vitamin D, creatinine, and PTH.

  • 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 ] [ Designated as safety issue: No ]
    Urine markers include phosphate, calcium, creatinine, albumin, and amino acids.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
  • 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) ] [ Designated as safety issue: Yes ]
  • Change from baseline to highest hemoglobin. [ Time Frame: Anytime between baseline (Day 0) and end of study or time of intervention ] [ Designated as safety issue: No ]
  • Change from baseline to highest ferritin. [ Time Frame: Anytime between baseline (Day 0) and end of study or time of intervention ] [ Designated as safety issue: No ]
  • Change from baseline to highest TSAT. [ Time Frame: Anytime between baseline (Day 0) and end of study or time of intervention ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: August 2010
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ferric Carboxymaltose (FCM) Drug: 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 Drug: Iron Dextran Injection
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.
Other Name: Dexferrum and Infed

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01307007

Locations
United States, Pennsylvania
Luitpold Pharmaceuticals, Inc.
Norristown, Pennsylvania, United States, 19403
Sponsors and Collaborators
Luitpold Pharmaceuticals
  More Information

No publications provided

Responsible Party: Marc Tokars, Luitpold Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01307007     History of Changes
Other Study ID Numbers: 1VIT08023
Study First Received: October 4, 2010
Last Updated: July 1, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Uterine Hemorrhage
Hypophosphatemia
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Uterine Diseases
Genital Diseases, Female
Hemorrhage
Pathologic Processes
Phosphorus Metabolism Disorders
Iron
Ferric Compounds
Iron-Dextran Complex
Dextrans
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Hematinics
Hematologic Agents
Therapeutic Uses
Anticoagulants
Plasma Substitutes
Blood Substitutes

ClinicalTrials.gov processed this record on September 18, 2014