Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 receiving erythropoietic agents, such as Procrit® and Aranesp®.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV iron | Experimental |
| |
| oral iron | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sodium Ferric Gluconate complex in sucrose | Drug | Sodium ferric gluconate complex in sucrose, 250 mg IV weekly for 4 doses |
|
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Hemoglobin Concentration | Baseline | |
| 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 |
|---|---|---|
| Baseline Serum Ferritin Concentration | Baseline | |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Adel R Rizkala, PharmD, MS | Watson Laboratories, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Ferrlecit | Sodium ferric gluconate complex in sucrose injection |
| FG001 | Oral Iron |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Ferrous sulfate tablets | Drug | ferrous sulfate 325 mg three times daily for 6 weeks |
|
| Baseline to 10 weeks |
| Tucson |
| Arizona |
| United States |
| 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 |
| St Louis | Missouri | United States |
| Detroit | 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 |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ferrlecit | Sodium ferric gluconate complex in sucrose injection |
| 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 | Baseline Hemoglobin Concentration | Posted | Jan 2010 | Mean | Standard Deviation | g/dL | Baseline |
|
|
| |||||||||||||||||||||||||||||
| Secondary | Baseline Serum Ferritin Concentration | Posted | Jan 2010 | Mean | Standard Deviation | ng/mL | Baseline |
|
| ||||||||||||||||||||||||||||||
| 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 |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ferrlecit | Sodium ferric gluconate complex in sucrose injection | 4 | 26 | 18 | 26 | ||
| EG001 | Oral Iron | 2 | 26 | 16 | 26 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acerbation of Chronic Heart Failure | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Pyelonephritis | Renal and urinary disorders | COSTART | Non-systematic Assessment |
| |
| Pain Chest | General disorders | COSTART | Non-systematic Assessment |
| |
| Acute Coronary Syndrome | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Myocardiac Infarction | Cardiac disorders | COSTART | Non-systematic Assessment |
| |
| Gout Attack | Metabolism and nutrition disorders | COSTART | Non-systematic Assessment |
| |
| Pulmonary Edema | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fever | General disorders | COSTART | Non-systematic Assessment |
| |
| Infection | Infections and infestations | COSTART | Non-systematic Assessment |
| |
| Accidental Injury | Injury, poisoning and procedural complications | COSTART | Non-systematic Assessment |
| |
| Abdominal Pain | General disorders | COSTART | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | COSTART | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Melena | Gastrointestinal disorders | COSTART | Non-systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | COSTART | Non-systematic Assessment |
| |
| Edema | Metabolism and nutrition disorders | COSTART | Non-systematic Assessment |
| |
| Peripheral Edema | Metabolism and nutrition disorders | COSTART | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | COSTART | Non-systematic Assessment |
| |
| Rhinitis | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
| |
| Increase Cough | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | COSTART | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gary Hoel, RPh, PhD, Executive Director of Clinical Research | Watson Laboratories, Inc. | 801-588-6641 | gary.hoel@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 |
Not provided
Not provided
| 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 |
Not provided
Not provided
| >=65 years |
|
| Male |
|
|
|
|