This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Luitpold Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01307007
First received: October 4, 2010
Last updated: June 13, 2017
Last verified: June 2017
October 4, 2010
June 13, 2017
September 2010
May 2011   (Final data collection date for primary outcome measure)
Changes in Blood Markers [ Time Frame: Day 35 ]
Changes in blood markers of phosphate
  • 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 ]
    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 ]
    Urine markers include phosphate, calcium, creatinine, albumin, and amino acids.
Complete list of historical versions of study NCT01307007 on ClinicalTrials.gov Archive Site
Not Provided
  • 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 ]
Not Provided
Not Provided
 
Hypophosphatemia With Ferric Carboxymaltose Vs. Iron Dextran in 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).
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).
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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
    Other Name: Injectafer
  • 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)
    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
    Intervention: Drug: Ferric Carboxymaltose (FCM)
  • 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.
    Intervention: Drug: Iron Dextran Injection
Wolf M, Koch TA, Bregman DB. Effects of iron deficiency anemia and its treatment on fibroblast growth factor 23 and phosphate homeostasis in women. J Bone Miner Res. 2013 Aug;28(8):1793-803. doi: 10.1002/jbmr.1923.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
69
August 2013
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 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)
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT01307007
1VIT08023
No
Not Provided
Plan to Share IPD: No
Luitpold Pharmaceuticals
Luitpold Pharmaceuticals
Not Provided
Study Director: Sumita Chowdhury, MD Luitpold Pharmaceuticals
Luitpold Pharmaceuticals
June 2017

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