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| ID | Type | Description | Link |
|---|---|---|---|
| FDA |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Ferric Gluconate Complex in Sucrose. | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Ferritin | Change from baseline to 2 weeks after last Fe dose | 14 weeks |
| Transferrin Saturation | Change from baseline to 2 weeks after last dose | 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the Effect of Intravenous Administration of Ferrlecit on Hematology Parameteres, on EPO Dose, and Safety. | 14 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary Hoel, RPh, PhD | Watson Laboratories, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16520948 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sodium Ferric Gluconate Complex |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sodium Ferric Gluconate Complex |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Serum Ferritin | Change from baseline to 2 weeks after last Fe dose | Per protocol (completer) population | Posted | Aug 2009 | Mean | Standard Deviation | ng/mL | 14 weeks |
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|
| ||||||||||||||||||||||||
| Secondary | Evaluate the Effect of Intravenous Administration of Ferrlecit on Hematology Parameteres, on EPO Dose, and Safety. | Not Posted | 14 weeks | |||||||||||||||||||||||||||||||||
| Primary | Transferrin Saturation | Change from baseline to 2 weeks after last dose | Per protocol (completer) population | Posted | Aug 2009 | Mean | Standard Deviation | % | 14 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gary Hoel, RPh, PhD | Watson Laboratories, Inc | 801-588-6641 | gary.hoel@watson.com |
| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic 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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