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This is a open-label, prospective study comparing intravenous (IV) iron supplementation to standard care in anemic patents undergoing peritoneal dialysis.
This is an open-label, prospective study comparing IV iron supplementation to standard care in anemic patients undergoing peritoneal dialysis. After successfully completing a 6 month enrollment period, qualifying patients were randomized to receive 1000mg of IV iron over a four week period, or no iron supplementation. Erythropoietin regimen was to remain stable. Patients were followed to day 71 for safety and efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29. |
|
| Group B | Active Comparator | Stable erythropoietin (EPO) dose and no supplemental iron. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venofer and stable erythropoietin (EPO) regimen | Drug | Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline to the Highest Hemoglobin up to Day 71 | Change from Baseline up to Day 71 |
| Measure | Description | Time Frame |
|---|---|---|
| The Mean Change From Baseline to the Highest Serum Transferrin Saturation (TSAT) up to Day 71 | Change from Baseline up to Day 71 | |
| The Mean Change From Baseline to the Highest Ferritin up to Day 71 | Change from Baseline up to Day 71 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark A Falone, MD | American Regent, Inc. | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17699248 | Background | Singh H, Reed J, Noble S, Cangiano JL, Van Wyck DB; United States Iron Sucrose (Venofer) Clinical Trials Group. Effect of intravenous iron sucrose in peritoneal dialysis patients who receive erythropoiesis-stimulating agents for anemia: a randomized, controlled trial. Clin J Am Soc Nephrol. 2006 May;1(3):475-82. doi: 10.2215/CJN.01541005. Epub 2006 Mar 29. |
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Recruitment Period: July 29, 2002 - September 6, 2004 Locations: Hospitals and Medical Clinics
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A: Venofer and Erythropoietin EPO Fixed Dose | Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29. |
| FG001 | Group B: Erythropoietin EPO Fixed Dose Only | Stable erythropoietin (EPO) dose and no supplemental iron. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A: Venofer and Erythropoietin EPO Fixed Dose | Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29. |
| BG001 | Group B: Erythropoietin EPO Fixed Dose Only |
| 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 | Mean Change From Baseline to the Highest Hemoglobin up to Day 71 | Intent-to-Treat Population (ITT): All safety population subjects who received at least 1 dose of study medication or EPO and had at least 1 post-baseline efficacy measurement. | Posted | Mean | Standard Deviation | g/dL | Change from Baseline up to Day 71 |
|
2 years 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 | Group A: Venofer and Erythropoietin EPO Fixed Dose | Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia NOS | Blood and lymphatic system disorders | MedDRA (6.0) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain NOS | Gastrointestinal disorders | MedDRA (6.0) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark A. Falone, MD | Luitpold Pharmaceuticals, Inc. | 610-650-4200 | 844 | 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 |
| D002985 | Clinical Protocols |
| ID | Term |
|---|---|
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005937 | Glucaric Acid |
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|
| stable erythropoietin (EPO) regimen | Drug | Stable erythropoietin (EPO) dose and no supplemental iron. |
|
|
| The Mean Change From Baseline to the Highest Reticulocyte Count up to Day 71 | Change from Baseline up to Day 71 |
Stable erythropoietin (EPO) dose and no supplemental iron. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | The Mean Change From Baseline to the Highest Serum Transferrin Saturation (TSAT) up to Day 71 | Intent-to-Treat Population (ITT) | Posted | Mean | Standard Deviation | percentage of change | Change from Baseline up to Day 71 |
|
|
|
| Secondary | The Mean Change From Baseline to the Highest Ferritin up to Day 71 | Intent-to-Treat Population (ITT) | Posted | Mean | Standard Deviation | ng/mL | Change from Baseline up to Day 71 |
|
|
|
| Secondary | The Mean Change From Baseline to the Highest Reticulocyte Count up to Day 71 | Intent-to-Treat Population (ITT) | Posted | Mean | Standard Deviation | percentage of change | Change from Baseline up to Day 71 |
|
|
|
| 9 |
| 75 |
| 33 |
| 75 |
| EG001 | Group B: Erythropoietin EPO Fixed Dose Only | Stable erythropoietin (EPO) dose and no supplemental iron. | 5 | 46 | 20 | 46 |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (6.0) |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (6.0) |
|
| Fibula Fracture | Injury, poisoning and procedural complications | MedDRA (6.0) |
|
| Gangrene NOS | Vascular disorders | MedDRA (6.0) |
|
| Hyperglycemia NOS | Metabolism and nutrition disorders | MedDRA (6.0) |
|
| Hypertension NOS | Vascular disorders | MedDRA (6.0) |
|
| Hypovolaemia | Metabolism and nutrition disorders | MedDRA (6.0) |
|
| Localized infection | Infections and infestations | MedDRA (6.0) |
|
| Lower limb fracture NOS | Musculoskeletal and connective tissue disorders | MedDRA (6.0) |
|
| Lymph node tuberculosis NOS | Infections and infestations | MedDRA (6.0) |
|
| Myocardial infarction | Cardiac disorders | MedDRA (6.0) |
|
| Peritoneal infection | Infections and infestations | MedDRA (6.0) |
|
| Upper respiratory tract infection NOS | Infections and infestations | MedDRA (6.0) |
|
| Catheter site infection | Infections and infestations | MedDRA (6.0) |
|
| Constipation | Gastrointestinal disorders | MedDRA (6.0) |
|
| Diarrhea NOS | Gastrointestinal disorders | MedDRA (6.0) |
|
| Hypertension NOS | Vascular disorders | MedDRA (6.0) |
|
| Nausea | Gastrointestinal disorders | MedDRA (6.0) |
|
| Oedema peripheral | General disorders | MedDRA (6.0) |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (6.0) |
|
| Peritoneal infection | Infections and infestations | MedDRA (6.0) |
|
| Pharyngitis | Respiratory, thoracic and mediastinal disorders | 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 |
| D013812 | Therapeutics |
| D016020 | Epidemiologic Study Characteristics |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |