- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00982007
Efficacy and Safety of Intravenous Ferric Carboxymaltose (FCM) in Patients With Iron Deficiency Anemia (IDA)
January 22, 2018 updated by: American Regent, Inc.
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
997
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Norristown, Pennsylvania, United States, 19403
- Luitpold Pharmaceuticals, Inc.
-
-
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
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
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 |
Intervention / Treatment |
---|---|
Experimental: Cohort 1 (Group A) - Ferric Carboxymaltose (FCM)
Intravenous (IV) iron
|
A total maximum cumulative dose of 1500 mg administered on Days 0 and 7.
|
Active Comparator: Cohort 1 (Group B) - Ferrous Sulfate
Oral iron - Ferrous Sulfate tablets
|
325 mg Ferrous Sulfate tablets taken orally three times a day
|
Active Comparator: Cohort 2 (Group D) - IV Iron (standard of care)
Other IV iron
|
IV standard of care (other IV iron) per the Investigator's discretion
|
Experimental: Cohort 2 (Group C) - Ferric Carboxymaltose (FCM)
Intravenous (IV) iron
|
A total maximum cumulative dose of 1500 mg administered on Days 0 and 7.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Day 35
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
September 1, 2009
Primary Completion (Actual)
March 1, 2011
Study Completion (Actual)
August 1, 2011
Study Registration Dates
First Submitted
September 21, 2009
First Submitted That Met QC Criteria
September 21, 2009
First Posted (Estimate)
September 22, 2009
Study Record Updates
Last Update Posted (Actual)
February 20, 2018
Last Update Submitted That Met QC Criteria
January 22, 2018
Last Verified
January 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1VIT09031
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.
Clinical Trials on Iron Deficiency Anemia
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Pennington Biomedical Research CenterRecruitingIron-deficiency | Iron Deficiency Anemia | Iron Deficiency Anemia TreatmentUnited States
-
Children's Hospital Los AngelesNot yet recruitingAnemia | Iron Deficiency Anemia | Anemia, Iron Deficiency | IDA - Iron Deficiency AnemiaUnited States
-
King's CollegeCompletedIron-deficiency | Iron Deficiency Anemia | Iron Deficiency (Without Anemia)United States
-
Arrowhead Regional Medical CenterRecruitingIron Deficiency Anemia of PregnancyUnited States
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Swiss Federal Institute of TechnologyUnited States Agency for International Development (USAID); Quadram Institute... and other collaboratorsCompletedIron-deficiency | Iron Deficiency Anemia | Iron Deficiency (Without Anemia)Peru
-
Luzerner KantonsspitalRecruitingIron Deficiency Anemia | Iron Deficiency Anemia Treatment | Iron DeficienciesSwitzerland
-
Children's Hospital Los AngelesWithdrawnAnemia | Iron-deficiency Anemia | Healthy ControlsUnited States
-
Baylor College of MedicineNational Heart, Lung, and Blood Institute (NHLBI)CompletedIron-deficiency | Iron Deficiency AnemiaUnited States
-
Iowa State UniversityCompletedIron-deficiency | Iron Deficiency Anemia | Iron Deficiency Anemia Treatment | Iron Deficiency Anaemia Due to Dietary CausesUnited States
-
Société des Produits Nestlé (SPN)CompletedIron-deficiency | Anemia | Iron Deficiency AnemiaPhilippines
Clinical Trials on Ferric Carboxymaltose (FCM)
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American Regent, Inc.Completed
-
American Regent, Inc.CompletedIron Deficiency Anemia (IDA)Poland, Russian Federation
-
King Hussein Cancer CenterHikma Pharmaceuticals LLCCompleted
-
American Regent, Inc.National Institute on Aging (NIA)Completed
-
Vifor PharmaICON Clinical Research; American Regent, Inc.CompletedChronic Kidney Disease | Iron Deficiency AnaemiaUnited Kingdom, United States, Australia, Austria, Belgium, Czech Republic, Denmark, France, Germany, Greece, Italy, Netherlands, Norway, Poland, Portugal, Romania, Spain, Sweden, Turkey
-
American Regent, Inc.CompletedRestless Legs Syndrome (RLS)
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American Regent, Inc.CompletedIron Deficiency Anemia | Impaired Renal FunctionUnited States
-
American Regent, Inc.Completed
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American Regent, Inc.CompletedFibromyalgia | Iron DeficiencyUnited States
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American Regent, Inc.CompletedPostpartum AnemiaUnited States