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This study compares the effect of Ferrlecit® (a form of intravenous iron) to ferrous sulfate (a form of oral iron) in treating anemia and iron deficiency in chronic kidney disease patients who are not receiving erythropoietic agents (hormones that stimulate the bone marrow to make more red blood cells).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV iron | Experimental | Sodium ferric gluconate |
|
| oral iron | Active Comparator | ferrous sulfate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Ferric Gluconate Complex in Sucrose Injection | Drug | Sodium Ferric Gluconate Complex in Sucrose Injection (Ferrlecit®), 250 mg IV weekly for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hemoglobin (Hgb) | Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d. | Baseline to 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Serum Ferritin | Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d. | Baseline to 10 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Naomi Dahl, Pharm.D. | Watson Laboratories, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tucson | Arizona | United States | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17035697 | Result | Agarwal R, Rizkala AR, Bastani B, Kaskas MO, Leehey DJ, Besarab A. A randomized controlled trial of oral versus intravenous iron in chronic kidney disease. Am J Nephrol. 2006;26(5):445-54. doi: 10.1159/000096174. Epub 2006 Oct 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | IV Iron | |
| FG001 | Oral Iron |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Ferrous sulfate tablets | Drug | ferrous sulfate, 325 mg oral, three times daily for 6 weeks |
|
| Los Angeles |
| California |
| United States |
| Palo Alto | California | United States |
| San Diego | California | United States |
| Hines | Illinois | United States |
| Indianapolis | Indiana | United States |
| Shreveport | Louisiana | United States |
| Baltimore | Maryland | United States |
| Springfield | Massachusetts | United States |
| Detroit | Michigan | United States |
| St Louis | Missouri | United States |
| Birmingham | New York | United States |
| Mineola | New York | United States |
| New York | New York | United States |
| The Bronx | New York | United States |
| Chapel Hill | North Carolina | United States |
| Cleveland | Ohio | United States |
| Philadelphia | Pennsylvania | United States |
| Charlotte | South Carolina | United States |
| Chattanooga | Tennessee | United States |
| Memphis | Tennessee | United States |
| Houston | Texas | United States |
| Fairfax | Virginia | United States |
| San Juan | Puerto Rico |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IV Iron | |
| BG001 | Oral Iron | |
| BG002 | Total | Total of all reporting groups |
| 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 |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Change in Hemoglobin (Hgb) | Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d. | Modified ITT with LOCF imputation | Posted | Mean | Standard Deviation | g/dL | Baseline to 10 weeks |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Change in Serum Ferritin | Change from baseline to 7 weeks after 4 consecutive weekly Ferrlecit 250 mg intravenious infusion and change from baseline to 4 weeks after 6 weeks oral ferrous sulfate 325 mg tablets t.i.d. | Modified ITT with LOCF imputation | Posted | Mean | Standard Deviation | ng/mL | Baseline to 10 weeks |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IV Iron | 4 | 44 | 22 | 44 | |||
| EG001 | Oral Iron | 4 | 45 | 21 | 45 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Exacerbation Gout | Metabolism and nutrition disorders | COSTART | Non-systematic Assessment |
| |
| Lower Exteremities Skin Abcess Lesion | Skin and subcutaneous tissue disorders | COSTART | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | COSTART | Non-systematic Assessment |
| |
| Worsening Chronic Kidney Disease | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Anaphylaxis | Immune system disorders | COSTART | Non-systematic Assessment |
| |
| Bilateral Pleural Iffusions | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
| |
| Acute Renal Failure | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Admitted to Hospital for Renal Biopsy | Renal and urinary disorders | COSTART | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Enlargement | General disorders | COSTART | Non-systematic Assessment |
| |
| Asthenia | General disorders | COSTART | Non-systematic Assessment |
| |
| Infection | Infections and infestations | COSTART | Non-systematic Assessment |
| |
| Abdominal Pain | Psychiatric disorders | COSTART | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | COSTART | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Melena | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Edema | Metabolism and nutrition disorders | COSTART | Non-systematic Assessment |
| |
| Parasthesia | Nervous system disorders | COSTART | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Naomi Dahl, PharmD Director, Clinical Affairs | Watson Pharmaceuticals, Inc | Naomi.dahl@watson.com |
| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| D007676 | Kidney Failure, Chronic |
| D000090463 | Iron Deficiencies |
| D000740 | Anemia |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| 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 |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C035552 | ferric gluconate |
| D013395 | Sucrose |
| D007505 | Iron-Dextran Complex |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000073893 | Sugars |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003911 | Dextrans |
| D005936 | Glucans |
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| >=65 years |
|
| Male |
|
| Puerto Rico |
|
|