Hypophosphatemia With Ferric Carboxymaltose Vs. Iron Dextran in Iron Deficiency Secondary to Heavy Uterine Bleeding
Primary Purpose
Iron Deficiency Anemia
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Ferric Carboxymaltose (FCM)
Iron Dextran Injection
Sponsored by
About this trial
This is an interventional treatment trial for Iron Deficiency Anemia
Eligibility 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)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ferric Carboxymaltose (FCM)
Iron Dextran Injection
Arm Description
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
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.
Outcomes
Primary Outcome Measures
Changes in Blood Markers
Changes in blood markers of phosphate
Secondary Outcome Measures
Full Information
NCT ID
NCT01307007
First Posted
October 4, 2010
Last Updated
January 19, 2018
Sponsor
American Regent, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01307007
Brief Title
Hypophosphatemia With Ferric Carboxymaltose Vs. Iron Dextran in Iron Deficiency Secondary to Heavy Uterine Bleeding
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
American Regent, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ferric Carboxymaltose (FCM)
Arm Type
Experimental
Arm Description
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
Arm Title
Iron Dextran Injection
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Ferric Carboxymaltose (FCM)
Other Intervention Name(s)
Injectafer
Intervention Description
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 Type
Drug
Intervention Name(s)
Iron Dextran Injection
Other Intervention Name(s)
Dexferrum and INFeD
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Blood Markers
Description
Changes in blood markers of phosphate
Time Frame
Day 35
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Falone, MD
Organizational Affiliation
American Regent, Inc.
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23505057
Citation
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.
Results Reference
result
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/23505057
Description
FGF23; IRON; PHOSPHATE; PTH; VITAMIN D
Learn more about this trial
Hypophosphatemia With Ferric Carboxymaltose Vs. Iron Dextran in Iron Deficiency Secondary to Heavy Uterine Bleeding
We'll reach out to this number within 24 hrs