Effect of Ferrlecit® Versus Oral Iron on Iron Deficient Chronic Kidney Disease (CKD) Patients Receiving Erythropoietic Agents

February 29, 2012 updated by: Watson Pharmaceuticals

A Randomized, Controlled, Open-label Study of the Safety and Efficacy of Ferrlecit® vs Oral Iron in Iron Deficient Patients With Chronic Kidney Disease Being Treated With Erythropoietic Therapy

This study compares the effect of Ferrlecit® (a form of intravenous iron) to ferrous sulfate (a form of oral iron) in treating anemia and iron deficiency in chronic kidney disease patients who are receiving erythropoietic agents, such as Procrit® and Aranesp®.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 4

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

  • Puerto Rico
      • San Juan, Puerto Rico
  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • Arizona
      • Tucson, Arizona, United States
    • California
      • Los Angeles, California, United States
      • Palo Alto, California, United States
      • San Diego, California, United States
    • Illinois
      • Hines, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Louisiana
      • Shreveport, Louisiana, United States
    • Maryland
      • Baltimore, Maryland, United States
    • Massachusetts
      • Springfield, Massachusetts, United States
    • Missouri
      • St. Louis, Missouri, United States
    • New York
      • Bronx, New York, United States
      • Detroit, New York, United States
      • Mineola, New York, United States
      • New York, New York, United States
    • North Carolina
      • Chapel Hill, North Carolina, United States
    • Ohio
      • Cleveland, Ohio, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
    • South Carolina
      • Charlotte, South Carolina, United States
    • Tennessee
      • Chattanooga, Tennessee, United States
      • Memphis, Tennessee, United States
    • Texas
      • Houston, Texas, United States
    • Virginia
      • Fairfax, Virginia, United States

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Moderate to severe anemia
  • Iron deficiency
  • Moderate to severe chronic kidney disease
  • Receiving therapy with erythropoietic agent

Exclusion Criteria:

  • Receiving dialysis
  • Known sensitivity to Ferrlecit® or any of its components
  • Clinically unstable

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: IV iron
Drug: Sodium Ferric Gluconate complex in sucrose
Sodium ferric gluconate complex in sucrose, 250 mg IV weekly for 4 doses
Other Names:
  • Ferrlecit
ACTIVE_COMPARATOR: oral iron
Drug: Ferrous sulfate tablets
ferrous sulfate 325 mg three times daily for 6 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hemoglobin (Hgb)
Time Frame: Baseline to 10 weeks
Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d.
Baseline to 10 weeks
Baseline Hemoglobin Concentration
Time Frame: Baseline
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Serum Ferritin
Time Frame: Baseline to 10 weeks
Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d.
Baseline to 10 weeks
Baseline Serum Ferritin Concentration
Time Frame: Baseline
Baseline

Collaborators and Investigators

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

Sponsor

Watson Pharmaceuticals

Investigators

  • Study Director: Adel R Rizkala, PharmD, MS, Watson Laboratories, 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

April 1, 2003

Primary Completion (ACTUAL)

May 1, 2005

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (ESTIMATE)

September 22, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

March 29, 2012

Last Update Submitted That Met QC Criteria

February 29, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FER0201

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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