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Study of the Safety and Efficacy of Ferrlecit® Maintenance Dosing in Pediatric Hemodialysis 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: NCT00224003
Recruitment Status : Completed
First Posted : September 22, 2005
Results First Posted : September 28, 2009
Last Update Posted : September 28, 2009
Sponsor:
Information provided by:
Watson Pharmaceuticals

Brief Summary:
A phase 4 clinical investigation in iron-replete pediatric hemodialysis patients, whose legal guardian had provided signed informed consent, and who had satisfied the inclusion and exclusion criteria of the study.

Condition or disease Intervention/treatment Phase
Anemia Drug: Sodium Ferric Gluconate Complex in Sucrose. Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-Label, Multi-Center Study of the Safety and Efficacy of Ferrlecit® in the Maintenance of Iron Stores in Pediatric Hemodialysis Patients Receiving Epoetin
Study Start Date : April 2003
Actual Primary Completion Date : March 2004
Actual Study Completion Date : February 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Dialysis




Primary Outcome Measures :
  1. Serum Ferritin [ Time Frame: 14 weeks ]
  2. Transferrin Saturation [ Time Frame: 14 weeks ]

Secondary Outcome Measures :
  1. Evaluate the Effect of Intravenous Administration of Ferrlecit on Hematology Parameteres, on EPO Dose, and Safety. [ Time Frame: 14 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female pediatric ESRD, Patients >_ 2 and <_ 16 years of age, whose legally authorized representative provided signed informed consent.
  • Stabilized on chronic hemodialysis therapy with an identified need for maintenance iron therapy.
  • Predetermined TSAT and serum Ferritin (at the screening visit).
  • Receiving a stable EPO dosing regimen.

Exclusion Criteria:

  • Receipt of any form of iron supplementation during the 2 weeks prior to the first Ferrlecit dosing.
  • Hypersensitivity to Ferrlecit or any of its inactive components.
  • High TSAT level.
  • High Serum Ferritin

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): NCT00224003


Locations
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United States, Alabama
Birmingham, Alabama, United States
United States, California
Los Angeles, California, United States
San Diego, California, United States
Stanford, California, United States
United States, Georgia
Atlanta, Georgia, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Missouri
Kansas City, Missouri, United States
United States, New York
Bronx, New York, United States
United States, Texas
Dallas, Texas, United States
United States, Washington
Seattle, Washington, United States
Sponsors and Collaborators
Watson Pharmaceuticals
Investigators
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Study Director: Gary Hoel, RPh, PhD Watson Laboratories, Inc.

Publications of Results:
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Responsible Party: Gary Hoel, RPh, PhD Executive Director, Clinical Research, Watson Laboratory, Inc
ClinicalTrials.gov Identifier: NCT00224003    
Other Study ID Numbers: FRO2001
FDA
First Posted: September 22, 2005    Key Record Dates
Results First Posted: September 28, 2009
Last Update Posted: September 28, 2009
Last Verified: August 2009
Keywords provided by Watson Pharmaceuticals:
Anemia
Additional relevant MeSH terms:
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Anemia
Hematologic Diseases
Ferric gluconate
Hematinics