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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00224055
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : March 29, 2012
Last Update Posted : March 29, 2012
Sponsor:
Information provided by (Responsible Party):
Watson Pharmaceuticals

Study Description
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Brief Summary:
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 not receiving erythropoietic agents (hormones that stimulate the bone marrow to make more red blood cells).

Condition or disease Intervention/treatment Phase
Anemia, Iron-Deficiency Kidney Failure, Chronic Drug: Sodium Ferric Gluconate Complex in Sucrose Injection Drug: Ferrous sulfate tablets Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 89 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized, Controlled, Open-label Study of the Safety and Efficacy of Ferrlecit® vs Oral Iron in Iron Deficient Patients With Chronic Kidney Disease
Study Start Date : April 2003
Actual Primary Completion Date : September 2004
Actual Study Completion Date : September 2004

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Arms and Interventions
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Arm Intervention/treatment
Experimental: IV iron
Sodium ferric gluconate
 Drug: Sodium Ferric Gluconate Complex in Sucrose Injection
Sodium Ferric Gluconate Complex in Sucrose Injection (Ferrlecit®), 250 mg IV weekly for 4 weeks
Active Comparator: oral iron
ferrous sulfate
 Drug: Ferrous sulfate tablets
ferrous sulfate, 325 mg oral, three times daily for 6 weeks


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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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:

  • Moderate to severe anemia
  • Iron deficiency
  • Moderate to severe chronic kidney disease

Exclusion Criteria:

  • Receiving dialysis
  • Known sensitivity to Ferrlecit® or any of its components
  • Receiving therapy with erythropoietic agent
  • Clinically unstable
Contacts and Locations
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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): NCT00224055


Locations
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United States, Arizona
Tucson, Arizona, United States
United States, California
Los Angeles, California, United States
Palo Alto, California, United States
San Diego, California, United States
United States, Illinois
Hines, Illinois, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Louisiana
Shreveport, Louisiana, United States
United States, Maryland
Baltimore, Maryland, United States
United States, Massachusetts
Springfield, Massachusetts, United States
United States, Michigan
Detroit, Michigan, United States
United States, Missouri
St. Louis, Missouri, United States
United States, New York
Birmingham, New York, United States
Bronx, New York, United States
Mineola, New York, United States
New York, New York, United States
United States, North Carolina
Chapel Hill, North Carolina, United States
United States, Ohio
Cleveland, Ohio, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, South Carolina
Charlotte, South Carolina, United States
United States, Tennessee
Chattanooga, Tennessee, United States
Memphis, Tennessee, United States
United States, Texas
Houston, Texas, United States
United States, Virginia
Fairfax, Virginia, United States
Puerto Rico
San Juan, Puerto Rico
Sponsors and Collaborators
Watson Pharmaceuticals
Investigators
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Study Director: Naomi Dahl, Pharm.D. Watson Laboratories, Inc.
More Information
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Publications of Results:

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Responsible Party: Watson Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00224055    
Other Study ID Numbers: FER0202
First Posted: September 22, 2005    Key Record Dates
Results First Posted: March 29, 2012
Last Update Posted: March 29, 2012
Last Verified: February 2012
Keywords provided by Watson Pharmaceuticals:
Iron deficiency
Anemia
Chronic kidney disease
 Sodium Ferric Gluconate
Anemia, Iron-Deficiency/drug therapy/etiology
Kidney Failure, Chronic/blood/complications/therapy
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Failure, Chronic
Anemia
Anemia, Iron-Deficiency
Hematologic Diseases
 Urologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases
Ferric gluconate
Hematinics