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To assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent, chronic renal failure in patients receiving or not receiving erythropoietin.
The intent of this study was to assess the safety and efficacy of two forms of iron therapy for the treatment of anemia in non-dialysis dependent, chronic renal failure patients receiving or not receiving erythropoietin. After an extensive enrollment period, patients were randomized to receive oral iron (ferrous sulfate, 325mg three times daily (TID) for 56 days) or IV iron sucrose (total 1000mg, 500mg X 2 OR 200mg X 5 within two weeks). Erythropoietin schedule was to remain unchanged during the 56 day study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venofer | Experimental | iron sucrose injection |
|
| Ferrous Sulfate | Active Comparator | oral iron |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venofer | Drug | iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14. |
| Measure | Description | Time Frame |
|---|---|---|
| Patients With an Increase in Hemoglobin >= 1gm/dL. | Change from Baseline up to Day 56 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With a Clinical Response | Clinical Response (change in Hemoblobin (Hgb) >= 1gm/dL and change in ferritin >= 160ng/ml) | Change from Baseline up to Day 56 |
| Highest Change From Baseline in Hemoglobin (g/dL) up to Day 56 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark A Falone, MD | American Regent, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Luitpold Pharmaceuticals | Valley Forge | Pennsylvania | 19403 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16316362 | Result | Van Wyck DB, Roppolo M, Martinez CO, Mazey RM, McMurray S; United States Iron Sucrose (Venofer) Clinical Trials Group. A randomized, controlled trial comparing IV iron sucrose to oral iron in anemic patients with nondialysis-dependent CKD. Kidney Int. 2005 Dec;68(6):2846-56. doi: 10.1111/j.1523-1755.2005.00758.x. |
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Eligibility requirements: Serum Transferrin Saturation (TSAT) <= to 25%, Ferritin <= to 300 ng/mL, and no iron following enrollment. At randomization subjects were stratified by gender, hemoglobin (Hgb) levels (< or = to 9.0 g/dL, 9.1 - 10.0 g/dL, 10.1 - 11.0 g/dL), and erythropoietin use.
Recruitment period: August 2003 to October 2004. Locations: Hospitals, Medical Clinics
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| ID | Title | Description |
|---|---|---|
| FG000 | Venofer | iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14. |
| FG001 | Ferrous Sulfate | oral iron tablets; 325 mg three times a day orally for 56 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Venofer | iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14. |
| BG001 | Ferrous Sulfate |
| 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 |
| 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 | Patients With an Increase in Hemoglobin >= 1gm/dL. | Intent to Treat (ITT) population exclusions: Venofer - 12 subjects excluded; Ferrous Sulfate - 9 subjects excluded; due to either no post-baseline efficacy data, or unstable use of erythropoietin during the eight weeks prior to randomization. | Posted | Number | participants | Change from Baseline up to Day 56 |
|
1 year and 2 months
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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 | Venofer | iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (6.0) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA (6.0) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark A. Falone, MD | Luitpold Pharmaceuticals, Inc. | 610-650-4200 | mfalone@luitpold.com |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000077605 | Ferric Oxide, Saccharated |
| C020748 | ferrous sulfate |
| D007501 | Iron |
| ID | Term |
|---|---|
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005937 | Glucaric Acid |
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|
| Ferrous Sulfate | Drug | oral iron tablets; 325 mg three times a day orally for 56 days |
|
|
| Change from Baseline up to Day 56 |
| Highest Change From Baseline in Ferritin (ng/mL) up to Day 56 | Change from Baseline up to Day 56 |
| Mean Change in Ferritin (ng/mL) From Baseline to Day 56 | Change from Baseline at Day 56 |
| Mean Change From Baseline in Serum Transferrin Saturation (TSAT) (%) at Day 56 | Change from Baseline at Day 56 |
| Mean Change From Baseline in Hemoglobin (g/dL) at Day 56 | Change from Baseline at Day 56 |
oral iron tablets; 325 mg three times a day orally for 56 days |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Number of Subjects With a Clinical Response | Clinical Response (change in Hemoblobin (Hgb) >= 1gm/dL and change in ferritin >= 160ng/ml) | Intent to Treat (ITT) population exclusions: Venofer - 12 subjects excluded; Ferrous Sulfate - 9 subjects excluded; due to either no post-baseline efficacy data, or unstable use of erythropoietin during the eight weeks prior to randomization. | Posted | Number | participants | Change from Baseline up to Day 56 |
|
|
|
| Secondary | Highest Change From Baseline in Hemoglobin (g/dL) up to Day 56 | Only subjects who completed the study from the Intent to Treat (ITT) population. | Posted | Mean | Standard Deviation | g/dL | Change from Baseline up to Day 56 |
|
|
|
| Secondary | Highest Change From Baseline in Ferritin (ng/mL) up to Day 56 | Only subjects who completed the study from the Intent to Treat (ITT) population. | Posted | Mean | Standard Deviation | ng/mL | Change from Baseline up to Day 56 |
|
|
|
| Secondary | Mean Change in Ferritin (ng/mL) From Baseline to Day 56 | Posted | Mean | Standard Deviation | ng/mL | Change from Baseline at Day 56 |
|
|
|
| Secondary | Mean Change From Baseline in Serum Transferrin Saturation (TSAT) (%) at Day 56 | Intent to Treat (ITT) population exclusions: Venofer - 12 subjects excluded; Ferrous Sulfate - 9 subjects excluded; due to either no post-baseline efficacy data, or unstable use of erythropoietin during the eight weeks prior to randomization. | Posted | Mean | Standard Deviation | percentage of change | Change from Baseline at Day 56 |
|
|
|
| Secondary | Mean Change From Baseline in Hemoglobin (g/dL) at Day 56 | Intent to Treat (ITT) population exclusions: Venofer - 12 subjects excluded; Ferrous Sulfate - 9 subjects excluded; due to either no post-baseline efficacy data, or unstable use of erythropoietin during the eight weeks prior to randomization. | Posted | Mean | Standard Deviation | g/dL | Change from Baseline at Day 56 |
|
|
|
| 10 |
| 91 |
| 37 |
| 91 |
| EG001 | Ferrous Sulfate | oral iron tablets; 325 mg three times a day orally for 56 days | 6 | 91 | 42 | 91 |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (6.0) |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA (6.0) |
|
| Fluid Overload | Metabolism and nutrition disorders | MedDRA (6.0) |
|
| Fracture reduction | Surgical and medical procedures | MedDRA (6.0) |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (6.0) |
|
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA (6.0) |
|
| Hypotension NOS | Vascular disorders | MedDRA (6.0) |
|
| Intraoperative haemorrhage | Injury, poisoning and procedural complications | MedDRA (6.0) |
|
| Lobar pneumonia NOS | Infections and infestations | MedDRA (6.0) |
|
| Mental status changes | General disorders | MedDRA (6.0) |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (6.0) |
|
| Pneumonia NOS | Infections and infestations | MedDRA (6.0) |
|
| Renal failure acute | Renal and urinary disorders | MedDRA (6.0) |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (6.0) |
|
| Sepsis NOS | Infections and infestations | MedDRA (6.0) |
|
| Syncope | Nervous system disorders | MedDRA (6.0) |
|
| Diarrhea NOS | Gastrointestinal disorders | MedDRA (6.0) |
|
| Dizziness | Nervous system disorders | MedDRA (6.0) |
|
| Dysgeusia | Gastrointestinal disorders | MedDRA (6.0) |
|
| Fatigue | General disorders | MedDRA (6.0) |
|
| Fecal Occult Blood Positive | Investigations | MedDRA (6.0) |
|
| Hypertension NOS | Vascular disorders | MedDRA (6.0) |
|
| Nausea | Gastrointestinal disorders | MedDRA (6.0) |
|
| Oedema NOS | General disorders | MedDRA (6.0) |
|
| Oedema peripheral | General disorders | MedDRA (6.0) |
|
| Urinary Tract Infection NOS | Infections and infestations | MedDRA (6.0) |
|
| Vomiting NOS | Gastrointestinal disorders | MedDRA (6.0) |
|
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| D013400 |
| Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D028561 | Transition Elements |
| D008670 | Metals |