Study of the Safety and Efficacy of Ferrlecit® Maintenance Dosing in Pediatric Hemodialysis Patients
NCT ID: NCT00224003
Last Updated: 2009-09-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
23 participants
INTERVENTIONAL
2003-04-30
2005-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Sodium Ferric Gluconate Complex in Sucrose.
Eligibility Criteria
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Inclusion Criteria
* 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
* Hypersensitivity to Ferrlecit or any of its inactive components.
* High TSAT level.
* High Serum Ferritin
2 Years
16 Years
ALL
No
Sponsors
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Watson Pharmaceuticals
INDUSTRY
Responsible Party
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Watson Laboratory, Inc
Principal Investigators
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Gary Hoel, RPh, PhD
Role: STUDY_DIRECTOR
Watson Laboratories, Inc.
Locations
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Birmingham, Alabama, United States
Los Angeles, California, United States
San Diego, California, United States
Stanford, California, United States
Atlanta, Georgia, United States
Boston, Massachusetts, United States
Kansas City, Missouri, United States
The Bronx, New York, United States
Dallas, Texas, United States
Seattle, Washington, United States
Countries
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References
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Warady BA, Zobrist RH, Finan E; Ferrlecit Pediatric Study Group. Sodium ferric gluconate complex maintenance therapy in children on hemodialysis. Pediatr Nephrol. 2006 Apr;21(4):553-60. doi: 10.1007/s00467-006-0042-5. Epub 2006 Mar 7.
Other Identifiers
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FDA
Identifier Type: -
Identifier Source: secondary_id
FRO2001
Identifier Type: -
Identifier Source: org_study_id
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