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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

October 4, 2010
July 1, 2013
August 2010
May 2011   (final data collection date for primary outcome 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 ] [ 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.
Same as current
Complete list of historical versions of study NCT01307007 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Hypophosphatemia With Intravenous Ferric Carboxymaltose Versus Iron Dextran in Women With Iron Deficiency Secondary to Heavy Uterine Bleeding
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

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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Iron Deficiency Anemia
  • 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
  • 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
  • Experimental: Ferric Carboxymaltose (FCM)
    Intervention: Drug: Ferric Carboxymaltose (FCM)
  • Active Comparator: Iron Dextran Injection
    Intervention: Drug: Iron Dextran Injection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
Not Provided
May 2011   (final data collection date for primary outcome measure)

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)
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01307007
1VIT08023
No
Marc Tokars, Luitpold Pharmaceuticals, Inc.
Luitpold Pharmaceuticals
Not Provided
Not Provided
Luitpold Pharmaceuticals
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP