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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dose level 1 | Experimental | 1.5 mg/kg |
|
| dose level 2 | Experimental | 3 mg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferrlecit (sodium ferric gluconate complex in sucrose injection) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Demonstrate and compare effectiveness of two Ferrlecit® doses in increasing hemoglobin in iron-deficient pediatric hemodialysis patients requiring repletion iron therapy. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate single-dose pharmacokinetics of Ferrlecit® in iron deficient pediatric hemodialysis patients and to access the safety profile of Ferrlecit® in pediatric hemodialysis patients. | 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GARY HOEL, RPh, PhD | WATSON LPHARMACEUTICAL | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
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| 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 |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D000090463 | Iron Deficiencies |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C035552 | ferric gluconate |
| D013395 | Sucrose |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000073893 | Sugars |
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