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

January 19, 2018 updated by: American Regent, Inc.

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
69

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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 Names:
  • Dexferrum and INFeD

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in Blood Markers
Time Frame: Day 35
Changes in blood markers of phosphate
Day 35

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
American Regent, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Mark Falone, MD, American Regent, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 4, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 2, 2011

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 19, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1VIT08023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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