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This is a phase 3 clinical investigation. Patients who meet the eligibility criteria and provide signed informed consent will be randomized to receive one of two levels of Ferrlecit or oral iron in a 1:1:1 ratio.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sodium ferric gluconate complex 125 mg | Experimental | 125 mg sodium ferric gluconate weekly x 8 weeks |
|
| Sodium ferric gluconate complex 250 mg | Experimental | 250 mg sodium ferric gluconate complex weekly x 4 weeks |
|
| Oral iron | Active Comparator | 325 mg ferrous sulfate three times daily x 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Ferric Gluconate Complex | Drug | 125 mg weekly x 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hemoglobin | Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection | Baseline to 5 weeks and 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hematocrit (Hct) | Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection | Baseline to 5 weeks and 9 weeks |
| Change From Baseline in Transferrin Saturation (TSAT). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gary Hoel, RPh, PhD | Watson Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Sodium Ferric Gluconate Complex 125 mg | 125 mg sodium ferric gluconate weekly x 8 weeks |
| FG001 | Sodium Ferric Gluconate Complex 250 mg | 250 mg sodium ferric gluconate complex weekly x 4 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Sodium Ferric Gluconate Complex | Drug | 250 mg weekly x 4 |
|
|
| Oral Iron | Drug | 325 mg ferrous sulfate orally three times daily x 8 weeks |
|
Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection |
| Baseline to 5 weeks and 9 weeks |
| Change From Baseline in Serum Ferritin. | Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection | Baseline to 5 weeks and 9 weeks |
| Responders by Treatment Group | Patients were classified as responders to treatment if they had an increase in Hgb of at least 1.0 g/dL assessed at 2 weeks following the final administration of Ferrlecit or 1 week following the last dose of oral iron. | Baseline to 5 weeks and 9 weeks |
| Mesa |
| Arizona |
| United States |
| Los Angeles | California | United States |
| Torrance | California | United States |
| New Haven | Connecticut | United States |
| Evanston | Illinois | United States |
| Shreveport | Louisiana | United States |
| Springfield | Massachusetts | United States |
| Worcester | Massachusetts | United States |
| Royal Oak | Michigan | United States |
| St Louis | Missouri | United States |
| New York | New York | United States |
| Chapel Hill | North Carolina | United States |
| Winston-Salem | North Carolina | United States |
| Tulsa | Oklahoma | United States |
| Philadelphia | Pennsylvania | United States |
| Sioux Falls | South Dakota | United States |
| Dallas | Texas | United States |
| Richmond | Virginia | United States |
| Sofia | Bulgaria |
| Varna | Bulgaria |
| Kelowna | Canada |
| Kitchener | Canada |
| London | Canada |
| Scarborough | Canada |
| Toronto | Canada |
| Zagreb | Croatia |
| Bangalore | India |
| Chandigarh | India |
| Chennai | India |
| Hyderabad | India |
| Lucknow | India |
| Māhīm | India |
| New Delhi | India |
| Col. Toriello Guerra | Mexico |
| Durango | Mexico |
| Mexico City | Mexico |
| Monterrey | Mexico |
| Tlalpan | Mexico |
| Zapopan | Mexico |
| Osijek | Poland |
| Moscow | Russia |
| Saint Petersburg | Russia |
| FG002 | Oral Iron | 325 mg ferrous sulfate three times daily x 8 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Sodium Ferric Gluconate Complex 125 mg | 125 mg sodium ferric gluconate weekly x 8 weeks |
| BG001 | Sodium Ferric Gluconate Complex 250 mg | 250 mg sodium ferric gluconate complex weekly x 4 weeks |
| BG002 | Oral Iron | 325 mg ferrous sulfate three times daily x 8 weeks |
| BG003 | 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 | Hemoglobin | Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection | modified intent to treat (mITT) with last observation carried forward (LOCF) imputation | Posted | Aug 2009 | Mean | Standard Deviation | ng/mL | Baseline to 5 weeks and 9 weeks |
|
|
| ||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Hematocrit (Hct) | Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection | Posted | Mean | Standard Deviation | percent | Baseline to 5 weeks and 9 weeks |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Transferrin Saturation (TSAT). | Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection | Posted | Mean | Standard Deviation | percent | Baseline to 5 weeks and 9 weeks |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Serum Ferritin. | Change from baseline to 1 week after the last oral iron dose or 2 weeks after the last sodium ferric gluconate injection | Posted | Mean | Standard Deviation | ng/mL | Baseline to 5 weeks and 9 weeks |
|
| |||||||||||||||||||||||||||||||||
| Secondary | Responders by Treatment Group | Patients were classified as responders to treatment if they had an increase in Hgb of at least 1.0 g/dL assessed at 2 weeks following the final administration of Ferrlecit or 1 week following the last dose of oral iron. | Posted | Number | participants | Baseline to 5 weeks and 9 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 | Sodium Ferric Gluconate Complex 125 mg | 125 mg sodium ferric gluconate weekly x 8 weeks | 3 | 46 | 16 | 46 | ||
| EG001 | Sodium Ferric Gluconate Complex 250 mg | 250 mg sodium ferric gluconate complex weekly x 4 weeks | 13 | 58 | 20 | 58 | ||
| EG002 | Oral Iron | 325 mg ferrous sulfate three times daily x 8 weeks | 7 | 42 | 12 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANEMIA | Blood and lymphatic system disorders | COSTART |
| ||
| CELLULITIS | Skin and subcutaneous tissue disorders | COSTART |
| ||
| CEREBROVASC ACCID | Vascular disorders | COSTART |
| ||
| DIARRHEA | Gastrointestinal disorders | COSTART |
| ||
| EDEMA LUNG | Respiratory, thoracic and mediastinal disorders | COSTART |
| ||
| FEVER | General disorders | COSTART |
| ||
| FIBRILLAT ATR | Cardiac disorders | COSTART |
| ||
| HEM RECTAL | Gastrointestinal disorders | COSTART |
| ||
| HYPERGLYCEM | Metabolism and nutrition disorders | COSTART |
| ||
| HYPERTENS | Cardiac disorders | COSTART |
| ||
| HYPERVOLEM | Metabolism and nutrition disorders | COSTART |
| ||
| HYPOTENS | Cardiac disorders | COSTART |
| ||
| INFARCT MYOCARD | Cardiac disorders | COSTART |
| ||
| INJECT SITE REACT | Surgical and medical procedures | COSTART |
| ||
| KETOSIS | Metabolism and nutrition disorders | COSTART |
| ||
| METRORRHAGIA | Reproductive system and breast disorders | COSTART |
| ||
| PANCYTOPENIA | Blood and lymphatic system disorders | COSTART |
| ||
| PERICARDITIS | Cardiac disorders | COSTART |
| ||
| PERITONITIS | General disorders | COSTART |
| ||
| PNEUMONIA | Respiratory, thoracic and mediastinal disorders | COSTART |
| ||
| SYNCOPE | Cardiac disorders | COSTART |
| ||
| ULCER STOMACH | Gastrointestinal disorders | COSTART |
| ||
| VOMIT | Gastrointestinal disorders | COSTART |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| LAB TEST ABNORM | Blood and lymphatic system disorders | COSTART |
| ||
| HYPERTENS | Cardiac disorders | COSTART |
| ||
| DIARRHEA | Gastrointestinal disorders | COSTART |
| ||
| HYPOTENS | Cardiac disorders | COSTART |
| ||
| INFECT | General disorders | COSTART |
| ||
| PAIN ABDO | Gastrointestinal disorders | COSTART |
| ||
| PAIN | General disorders | COSTART |
| ||
| NAUSEA | Gastrointestinal disorders | COSTART |
|
Primary endpoint for the 250 mg dose was 4 weeks earlier than the endpoint for the 125 mg dose, which may have contributed to lower Hbg increase with the 250 mg dose at endpoint.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gary Hoel, RPh, PhD | Watson Laboratories, Inc | 801-588-6641 | gary.hoel@watson.com |
| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000090463 | Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C035552 | ferric gluconate |
| D007501 | Iron |
| ID | Term |
|---|---|
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Mexico |
|
| Poland |
|
| Croatia |
|
| Bulgaria |
|
| Russian Federation |
|
| India |
|
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