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Hypophosphatemia With Ferric Carboxymaltose Vs. Iron Dextran in Iron Deficiency Secondary to Heavy Uterine Bleeding

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01307007
First Posted: March 2, 2011
Last Update Posted: June 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Luitpold Pharmaceuticals
  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
Intervention Model: Parallel Assignment
Masking: None (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 [ Time Frame: Day 35 ]
    Changes in blood markers of phosphate


Enrollment: 69
Study Start Date: September 2010
Study Completion Date: August 2013
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Other Name: Injectafer
Active Comparator: 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.
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

Detailed Description:
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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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 transferrin saturation (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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01307007


Sponsors and Collaborators
Luitpold Pharmaceuticals
Investigators
Study Director: Sumita Chowdhury, MD Luitpold Pharmaceuticals
  More Information

Additional Information:
Publications:
Responsible Party: Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01307007     History of Changes
Other Study ID Numbers: 1VIT08023
First Submitted: October 4, 2010
First Posted: March 2, 2011
Results First Submitted: July 22, 2015
Results First Posted: June 27, 2017
Last Update Posted: June 27, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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
Hematinics
Anticoagulants
Plasma Substitutes
Blood Substitutes