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Trial record 62 of 383 for:    FERRIC CATION

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

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ClinicalTrials.gov Identifier: NCT01307007
Recruitment Status : Completed
First Posted : March 2, 2011
Results First Posted : June 27, 2017
Last Update Posted : February 16, 2018
Sponsor:
Information provided by (Responsible Party):
American Regent, Inc.

Tracking Information
First Submitted Date  ICMJE October 4, 2010
First Posted Date  ICMJE March 2, 2011
Results First Submitted Date  ICMJE July 22, 2015
Results First Posted Date  ICMJE June 27, 2017
Last Update Posted Date February 16, 2018
Study Start Date  ICMJE September 2010
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 13, 2017)
Changes in Blood Markers [ Time Frame: Day 35 ]
Changes in blood markers of phosphate
Original Primary Outcome Measures  ICMJE
 (submitted: March 1, 2011)
  • 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.
Change History Complete list of historical versions of study NCT01307007 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2011)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Hypophosphatemia With Ferric Carboxymaltose Vs. Iron Dextran in Iron Deficiency Secondary to Heavy Uterine Bleeding
Official Title  ICMJE 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
Brief 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).
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Iron Deficiency Anemia
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * 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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 13, 2017)
69
Original Estimated Enrollment  ICMJE
 (submitted: March 1, 2011)
40
Actual Study Completion Date  ICMJE August 2013
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01307007
Other Study ID Numbers  ICMJE 1VIT08023
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party American Regent, Inc.
Study Sponsor  ICMJE American Regent, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mark Falone, MD American Regent, Inc.
PRS Account American Regent, Inc.
Verification Date January 2018

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