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Comparison of three potential iron sucrose maintenance regimens in pediatric chronic kidney disease (CKD) patients
Randomized, controlled, open label trial of pediatric CKD patients on stable erythropoietin (EPO) therapy. Patients will be followed for 12 weeks to assess safety (incidence of adverse events) and efficacy (clinical success)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venofer (0.5 mg/kg) | Experimental | 0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously |
|
| Venofer (1.0 mg/kg) | Experimental | 1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously |
|
| Venofer (2.0 mg/kg) | Experimental | 2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venofer (iron sucrose injection) | Drug | 0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety Profile: Number of Subjects Experiencing at Least 1 Adverse Event | Safety Profile: Number of subjects who experienced at least 1 adverse event in each arm | baseline through week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Achieving Clinical Success | Summary of the Number of Subjects Achieving Clinical Success During the 12-Week Study Period - Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive, TSAT between 20% and 50%, Inclusive, and Stable EPO Dosing (±25% of Baseline Dose) | anytime during the 12 week post-baseline period |
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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 Pharmaceutials | Norristown | Pennsylvania | 19403 | United States |
Stable erythropoietin (EPO) dose (±25% of current dose) for 8 weeks prior to the qualifying screening visit.
Hospitals and Medical Clinics; Study Period - October 24, 2005 through January 23, 2009
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| ID | Title | Description |
|---|---|---|
| FG000 | Venofer (0.5 mg/kg) | 0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously |
| FG001 | Venofer (1.0 mg/kg) | 1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously |
| FG002 | Venofer (2.0 mg/kg) | 2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Venofer (0.5 mg/kg) | 0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously |
| BG001 | Venofer (1.0 mg/kg) | 1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously |
| 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 | Safety Profile: Number of Subjects Experiencing at Least 1 Adverse Event | Safety Profile: Number of subjects who experienced at least 1 adverse event in each arm | Safety Population - Subjects who received at least 1 dose of study drug. | Posted | Number | participants | baseline through week 12 |
|
3 years and 10 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 (0.5 mg/kg) | 0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood pressure increased | Investigations | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark A. Falone, MD | Luitpold Pharmaceuticals, Inc. | 601-650-4200 | mfalone@luitpold.com |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
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| ID | Term |
|---|---|
| D000077605 | Ferric Oxide, Saccharated |
| ID | Term |
|---|---|
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005937 | Glucaric Acid |
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| Venofer (iron sucrose injection) | Drug | 1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously |
|
| Venofer (iron sucrose injection) | Drug | 2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously |
|
| Percentage (%) of Subjects Achieving Clinical Success |
Summary of the Percentage (%) of Subjects Achieving Clinical Success During the 12-Week Study Period - Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive, TSAT between 20% and 50%, Inclusive, and stable EPO Dosing (±25% of Baseline Dose) |
| anytime during the 12 week post-baseline period |
| Number of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive | Summary of the Number of Subjects with Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive | anytime during the 12-week post-baseline period |
| Percentage (%) of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive | Summary of the Percentage (%) of Subjects with Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive | anytime during the 12 week post-baseline period |
| Proportion of Subjects With Transferrin Saturation (TSAT) Between 20% and 50%, Inclusive | Summary of the Proportion of Subjects with transferrin saturation (TSAT) between 20% and 50%, Inclusive | anytime during the 12 week post-baseline period |
| Percentage (%) of Subjects With TSAT Between 20% and 50%, Inclusive | Summary of the Percentage (%) of Subjects with TSAT between 20% and 50%, Inclusive | anytime during the 12 week post-baseline period |
| Proportion of Subjects With Stable Erythropoietin (EPO) Dosing or a Decrease >25% in EPO Dose From Baseline | Summary of the Proportion of Subjects with Stable erythropoietin (EPO) Dosing or a Decrease >25% in EPO dose from Baseline | anytime during the 12 week post-baseline period |
| Percentage (%) of Subjects With Stable EPO Dosing or a Decrease >25% in EPO Dose From Baseline | Summary of the Percentage (%) of Subjects with Stable EPO Dosing or a Decrease >25% in EPO Dose from Baseline | anytime during the 12 week post-baseline period |
| BG002 | Venofer (2.0 mg/kg) | 2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Venofer (2.0 mg/kg) |
2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously |
|
|
| Secondary | Number of Subjects Achieving Clinical Success | Summary of the Number of Subjects Achieving Clinical Success During the 12-Week Study Period - Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive, TSAT between 20% and 50%, Inclusive, and Stable EPO Dosing (±25% of Baseline Dose) | mITT subjects | Posted | Number | participants | anytime during the 12 week post-baseline period |
|
|
|
| Secondary | Percentage (%) of Subjects Achieving Clinical Success | Summary of the Percentage (%) of Subjects Achieving Clinical Success During the 12-Week Study Period - Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive, TSAT between 20% and 50%, Inclusive, and stable EPO Dosing (±25% of Baseline Dose) | mITT subjects | Posted | Number | percentage of subjects | anytime during the 12 week post-baseline period |
|
|
|
| Secondary | Number of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive | Summary of the Number of Subjects with Hemoglobin between 10.5 g/dL and 14.0 g/dL, Inclusive | mITT subjects | Posted | Number | participants | anytime during the 12-week post-baseline period |
|
|
|
| Secondary | Percentage (%) of Subjects With Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive | Summary of the Percentage (%) of Subjects with Hemoglobin Between 10.5 g/dL and 14.0 g/dL, Inclusive | mITT subjects | Posted | Number | percentage of subjects | anytime during the 12 week post-baseline period |
|
|
|
| Secondary | Proportion of Subjects With Transferrin Saturation (TSAT) Between 20% and 50%, Inclusive | Summary of the Proportion of Subjects with transferrin saturation (TSAT) between 20% and 50%, Inclusive | mITT subjects | Posted | Number | participants | anytime during the 12 week post-baseline period |
|
|
|
| Secondary | Percentage (%) of Subjects With TSAT Between 20% and 50%, Inclusive | Summary of the Percentage (%) of Subjects with TSAT between 20% and 50%, Inclusive | mITT subjects | Posted | Number | percentage of subjects | anytime during the 12 week post-baseline period |
|
|
|
| Secondary | Proportion of Subjects With Stable Erythropoietin (EPO) Dosing or a Decrease >25% in EPO Dose From Baseline | Summary of the Proportion of Subjects with Stable erythropoietin (EPO) Dosing or a Decrease >25% in EPO dose from Baseline | mITT subjects | Posted | Number | participants | anytime during the 12 week post-baseline period |
|
|
|
| Secondary | Percentage (%) of Subjects With Stable EPO Dosing or a Decrease >25% in EPO Dose From Baseline | Summary of the Percentage (%) of Subjects with Stable EPO Dosing or a Decrease >25% in EPO Dose from Baseline | mITT subjects | Posted | Number | percentage of subjects | anytime during the 12 week post-baseline period |
|
|
|
| 5 |
| 47 |
| 13 |
| 47 |
| EG001 | Venofer (1.0 mg/kg) | 1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously | 10 | 47 | 15 | 47 |
| EG002 | Venofer (2.0 mg/kg) | 2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously | 10 | 47 | 14 | 47 |
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
|
| Arteriovenous graft thrombosis | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
|
| Azotaemia | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
|
| Clavicle fracture | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
|
| Enterobacter bacteraemia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Faecaloma | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hyperparathyroidism | Endocrine disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypertension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypertensive encephalopathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pericardial effusion | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Peritonitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Pyrexia | General disorders | CTCAE (3.0) | Systematic Assessment |
|
| Renal Transplant | Surgical and medical procedures | CTCAE (3.0) | Systematic Assessment |
|
| Subdural haematoma | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
|
| Supraventricular tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Ventricular arrhythmia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
|
| Peritonitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Renal Transplant | Surgical and medical procedures | CTCAE (3.0) | Systematic Assessment |
|
| Respiratory tract infection viral | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
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| 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 |
| D013400 |
| Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |