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

  • United States
    • 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
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.

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

American Regent, Inc.

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

Clinical Trials on Ferric Carboxymaltose (FCM)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Croatia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe