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Trial record 19 of 46 for:    FERRIC SULFATE

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

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ClinicalTrials.gov Identifier: NCT00982007
Recruitment Status : Completed
First Posted : September 22, 2009
Results First Posted : October 18, 2013
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
American Regent, Inc.

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.

Condition or disease Intervention/treatment Phase
Iron Deficiency Anemia Drug: Ferric Carboxymaltose (FCM) Drug: Ferrous Sulfate Tablets Drug: IV Iron (standard of care) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 997 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2009
Actual Primary Completion Date : March 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arm Intervention/treatment
Experimental: Cohort 1 (Group A) - Ferric Carboxymaltose (FCM)
Intravenous (IV) iron
Drug: Ferric Carboxymaltose (FCM)
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
Drug: 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
Drug: IV Iron (standard of care)
IV standard of care (other IV iron) per the Investigator's discretion

Experimental: Cohort 2 (Group C) - Ferric Carboxymaltose (FCM)
Intravenous (IV) iron
Drug: Ferric Carboxymaltose (FCM)
A total maximum cumulative dose of 1500 mg administered on Days 0 and 7.




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00982007


Locations
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United States, Pennsylvania
Luitpold Pharmaceuticals, Inc.
Norristown, Pennsylvania, United States, 19403
Sponsors and Collaborators
American Regent, Inc.

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Responsible Party: American Regent, Inc.
ClinicalTrials.gov Identifier: NCT00982007     History of Changes
Other Study ID Numbers: 1VIT09031
First Posted: September 22, 2009    Key Record Dates
Results First Posted: October 18, 2013
Last Update Posted: February 20, 2018
Last Verified: January 2018

Keywords provided by American Regent, Inc.:
IDA

Additional relevant MeSH terms:
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Ferric Compounds
Anemia
Anemia, Iron-Deficiency
Deficiency Diseases
Hematologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Malnutrition
Nutrition Disorders
Iron
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hematinics