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This study explores the safety and efficacy of intravenous iron therapy in anemic hemodialysis patients treated with epoetin alfa, who have higher serum ferritin levels, but low to normal transferrin saturation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferric gluconate | Experimental |
| |
| standard of care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium ferric gluconate, | Drug | Sodium ferric gluconate, 125 mg IV given at 8 consecutive hemodialysis sessions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in hemoglobin and anemia medications | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in various iron indices | 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adel R. Rizkala, Pharm.D., MS | Watson Laboratories, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bakersfield | California | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17267740 | Result | Coyne DW, Kapoian T, Suki W, Singh AK, Moran JE, Dahl NV, Rizkala AR; DRIVE Study Group. Ferric gluconate is highly efficacious in anemic hemodialysis patients with high serum ferritin and low transferrin saturation: results of the Dialysis Patients' Response to IV Iron with Elevated Ferritin (DRIVE) Study. J Am Soc Nephrol. 2007 Mar;18(3):975-84. doi: 10.1681/ASN.2006091034. Epub 2007 Jan 31. | |
| 17396118 |
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| Glendale |
| California |
| United States |
| Los Angeles | California | United States |
| Santa Rosa | California | United States |
| Torrance | California | United States |
| Lauderdale Lakes | Florida | United States |
| Tampa | Florida | United States |
| Roswell | Georgia | United States |
| Waycross | Georgia | United States |
| Crestwood | Illinois | United States |
| Wichita | Kansas | United States |
| Shreveport | Louisiana | United States |
| Boston | Massachusetts | United States |
| Kalamazoo | Michigan | United States |
| Royal Oak | Michigan | United States |
| Columbia | Missouri | United States |
| St Louis | Missouri | United States |
| North Brunswick | New Jersey | United States |
| Brooklyn | New York | United States |
| Minneola | New York | United States |
| New York | New York | United States |
| Youngstown | Ohio | United States |
| Philadelphia | Pennsylvania | United States |
| Chattanooga | Tennessee | United States |
| Knoxville | Tennessee | United States |
| Arlington | Texas | United States |
| Houston | Texas | United States |
| San Antonio | Texas | United States |
| Morgantown | West Virginia | United States |
| Result |
| Singh AK, Coyne DW, Shapiro W, Rizkala AR; DRIVE Study Group. Predictors of the response to treatment in anemic hemodialysis patients with high serum ferritin and low transferrin saturation. Kidney Int. 2007 Jun;71(11):1163-71. doi: 10.1038/sj.ki.5002223. Epub 2007 Mar 28. |
| 18216316 | Result | Kapoian T, O'Mara NB, Singh AK, Moran J, Rizkala AR, Geronemus R, Kopelman RC, Dahl NV, Coyne DW. Ferric gluconate reduces epoetin requirements in hemodialysis patients with elevated ferritin. J Am Soc Nephrol. 2008 Feb;19(2):372-9. doi: 10.1681/ASN.2007050606. Epub 2008 Jan 23. |
| 19034302 | Result | Pizzi LT, Bunz TJ, Coyne DW, Goldfarb DS, Singh AK. Ferric gluconate treatment provides cost savings in patients with high ferritin and low transferrin saturation. Kidney Int. 2008 Dec;74(12):1588-95. doi: 10.1038/ki.2008.489. Epub 2008 Oct 1. |
| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000090463 | Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C035552 | ferric gluconate |
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