Study of the Efficacy of Two Doses of Ferrlecit in the Treatment of Iron Deficiency in Pediatric Hemodialysis Patients
NCT ID: NCT00223964
Last Updated: 2012-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
59 participants
INTERVENTIONAL
2003-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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dose level 1
1.5 mg/kg
Ferrlecit (sodium ferric gluconate complex in sucrose injection)
dose level 2
3 mg/kg
Ferrlecit (sodium ferric gluconate complex in sucrose injection)
Interventions
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Ferrlecit (sodium ferric gluconate complex in sucrose injection)
Eligibility Criteria
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Inclusion Criteria
* Predetermined TSAT and serum ferritin levels
* Receiving chronic hemodialysis therapy with an identified need for repletion iron therapy.
* Receiving a stable epoetin (EPO) dosing regimen.
Exclusion Criteria
* Blood transfusion.
* Hypersensitivity to Ferrlecit®.
* Significant inflammatory conditions.
2 Years
16 Years
ALL
No
Sponsors
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Watson Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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GARY HOEL, RPh, PhD
Role: STUDY_DIRECTOR
WATSON LPHARMACEUTICAL
Locations
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Birmingham, Alabama, United States
Los Angeles, California, United States
San Diego, California, United States
Stanford, California, United States
Boston, Massachusetts, United States
Kansas City, Missouri, United States
The Bronx, New York, United States
Seattle, Washington, United States
Aruascalientes, , Mexico
Mexico City, , Mexico
Bialystok, , Poland
Gdansk, , Poland
Krakow, , Poland
Lodz, , Poland
Lublin, , Poland
Szczecin, , Poland
Torum, , Poland
Wroclaw, , Poland
Zabrze, , Poland
Bashkortostan, , Russia
Moscow, , Russia
Saint Petersburg, , Russia
Tartarstan, , Russia
Belgrade, , Serbia
Countries
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Other Identifiers
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FR01006
Identifier Type: -
Identifier Source: org_study_id