search
Back to results

Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia (IDA)

Primary Purpose

Iron Deficiency Anemia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ferric Carboxymaltose (FCM)
Ferrous Sulfate Tablets
IV Iron (standard of care)
Ferric Carboxymaltose (FCM)
Sponsored by
American Regent, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iron Deficiency Anemia focused on measuring IDA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male or female subjects ≥ to 18 years of age and able to give informed consent.
  • Diagnosis of Iron Deficiency Anemia (IDA).
  • Hemoglobin (Hgb) ≤ to 11 g/dL.
  • Ferritin ≤ to 100 ng/mL or ≤ 300 when Transferrin Saturation (TSAT) was ≤ 30%.
  • Must demonstrate an unsatisfactory response or intolerance to oral iron.

Exclusion Criteria:

  • Known hypersensitivity reaction to any component of ferric carboxymaltose or ferrous sulfate.
  • Previously randomized in a clinical study of Ferric Carboxymaltose (FCM).
  • Requires dialysis for treatment of chronic kidney disease.
  • No evidence of iron deficiency.
  • Any non-viral infection.
  • AST or ALT at screen 1, 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.
  • Estimated life expectancy of less than 6 months or, for cancer patients, an ECOG Performance Status greater than 1.
  • 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 females who are of childbearing potential and who are not willing to use an acceptable form of contraception.

Sites / Locations

  • Luitpold Pharmaceuticals, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Experimental

Arm Label

Cohort 1 (Group A) - Ferric Carboxymaltose (FCM)

Cohort 1 (Group B) - Ferrous Sulfate

Cohort 2 (Group D) - IV Iron (standard of care)

Cohort 2 (Group C) - Ferric Carboxymaltose (FCM)

Arm Description

Intravenous (IV) iron

Oral iron - Ferrous Sulfate tablets

Other IV iron

Intravenous (IV) iron

Outcomes

Primary Outcome Measures

Mean Increase From Baseline to the Highest Observed Hemoglobin Value Between Baseline and Day 35 or Time of Intervention for Patients Taking FCM as Compared to That for Patients Taking Ferrous Sulfate.

Secondary Outcome Measures

Full Information

First Posted
September 21, 2009
Last Updated
January 22, 2018
Sponsor
American Regent, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT00982007
Brief Title
Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia (IDA)
Official Title
A Multi-center, Randomized, Active Controlled Study to Investigate the Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia (IDA)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
August 2011 (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 main objective of this study is to demonstrate the efficacy and safety of an investigational intravenous (IV) iron, ferric carboxymaltose (FCM), compared to oral iron in subjects who have iron deficiency anemia (IDA) and have shown an unsatisfactory response to oral iron.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron Deficiency Anemia
Keywords
IDA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
997 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1 (Group A) - Ferric Carboxymaltose (FCM)
Arm Type
Experimental
Arm Description
Intravenous (IV) iron
Arm Title
Cohort 1 (Group B) - Ferrous Sulfate
Arm Type
Active Comparator
Arm Description
Oral iron - Ferrous Sulfate tablets
Arm Title
Cohort 2 (Group D) - IV Iron (standard of care)
Arm Type
Active Comparator
Arm Description
Other IV iron
Arm Title
Cohort 2 (Group C) - Ferric Carboxymaltose (FCM)
Arm Type
Experimental
Arm Description
Intravenous (IV) iron
Intervention Type
Drug
Intervention Name(s)
Ferric Carboxymaltose (FCM)
Intervention Description
A total maximum cumulative dose of 1500 mg administered on Days 0 and 7.
Intervention Type
Drug
Intervention Name(s)
Ferrous Sulfate Tablets
Intervention Description
325 mg Ferrous Sulfate tablets taken orally three times a day
Intervention Type
Drug
Intervention Name(s)
IV Iron (standard of care)
Intervention Description
IV standard of care (other IV iron) per the Investigator's discretion
Intervention Type
Drug
Intervention Name(s)
Ferric Carboxymaltose (FCM)
Intervention Description
A total maximum cumulative dose of 1500 mg administered on Days 0 and 7.
Primary Outcome Measure Information:
Title
Mean Increase From Baseline to the Highest Observed Hemoglobin Value Between Baseline and Day 35 or Time of Intervention for Patients Taking FCM as Compared to That for Patients Taking Ferrous Sulfate.
Time Frame
Day 35

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female subjects ≥ to 18 years of age and able to give informed consent. Diagnosis of Iron Deficiency Anemia (IDA). Hemoglobin (Hgb) ≤ to 11 g/dL. Ferritin ≤ to 100 ng/mL or ≤ 300 when Transferrin Saturation (TSAT) was ≤ 30%. Must demonstrate an unsatisfactory response or intolerance to oral iron. Exclusion Criteria: Known hypersensitivity reaction to any component of ferric carboxymaltose or ferrous sulfate. Previously randomized in a clinical study of Ferric Carboxymaltose (FCM). Requires dialysis for treatment of chronic kidney disease. No evidence of iron deficiency. Any non-viral infection. AST or ALT at screen 1, 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. Estimated life expectancy of less than 6 months or, for cancer patients, an ECOG Performance Status greater than 1. 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 females who are of childbearing potential and who are not willing to use an acceptable form of contraception.
Facility Information:
Facility Name
Luitpold Pharmaceuticals, Inc.
City
Norristown
State/Province
Pennsylvania
ZIP/Postal Code
19403
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia (IDA)

We'll reach out to this number within 24 hrs