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Sponsored by: |
Watson Pharmaceuticals |
Information provided by: | Watson Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00223964 |
This was a multi-center study in iron-deficient pediatric hemodialysis patients, whose legal guardian had provided signed informed consent and satisfied the inclusion and exclusion criteria.
Condition | Intervention | Phase |
Anemia |
Drug: Ferrlecit (sodium ferric gluconate complex in sucrose injection) |
Phase IV |
MedlinePlus related topics: | Anemia Dialysis Kidney Failure |
ChemIDplus related topics: | Epoetin alfa Erythropoietin Sucrose Sodium ferric gluconate complex D-Gluconic acid, monosodium salt Gluconic acid Manganese gluconate |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Randomized Double-Blind Parallel Group MultiCenter Study of the Efficacy of Two Doses of Ferrlecit® in Treatment of Iron Deficiency in Pediatric Hemodialysis Patients Receiving Epoetin. |
Study Start Date: | June 2003 |
Ages Eligible for Study: | 2 Years to 16 Years |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Exclusion Criteria:
United States, Alabama | |||||
BIRMINGHAM, Alabama, United States | |||||
United States, California | |||||
Stanford, California, United States | |||||
San Diego, California, United States | |||||
LOS ANGELES, California, 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, Washington | |||||
SEATTLE, Washington, United States | |||||
Mexico | |||||
MEXICO CITY, Mexico | |||||
ARUASCALIENTES, Mexico | |||||
Poland | |||||
KRAKOW, Poland | |||||
LODZ, Poland | |||||
WROCLAW, Poland | |||||
GDANSK, Poland | |||||
ZABRZE, Poland | |||||
LUBLIN, Poland | |||||
BIALYSTOK, Poland | |||||
TORUM, Poland | |||||
SZCZECIN, Poland | |||||
Russian Federation | |||||
MOSCOW, Russian Federation | |||||
SAINT PETERSBURG, Russian Federation | |||||
TARTARSTAN, Russian Federation | |||||
BASHKORTOSTAN, Russian Federation | |||||
Serbia and Montenegro | |||||
BELGRADE, Serbia and Montenegro |
Watson Pharmaceuticals |
Study Director: | GARY HOEL, RPh, PhD | WATSON LPHARMACEUTICAL |
Study ID Numbers: | FR01006 |
First Received: | September 13, 2005 |
Last Updated: | July 20, 2006 |
ClinicalTrials.gov Identifier: | NCT00223964 |
Health Authority: | United States: Food and Drug Administration |
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