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The Objective of this study is to study the safety of FCM in patients with anemia caused by chronic kidney failure
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferric Carboxymaltose (FCM) | Experimental | Subjects received an undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg) or subjects received 200 mg of FCM IV push undiluted directly into the venous line of the dialyzer. |
|
| Standard Medical Care (SMC) | Active Comparator | SMC for IDA (as determined by the Investigator) for treating CKD related anemia. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferric Carboxymaltose | Drug |
| ||
| Standard Medical Care (SMC) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-emergent Serious Adverse Events (SAE's) | from Day 0 through 30 days after the last dose of study drug |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Luitpold Pharmaceuticals | Norristown | Pennsylvania | 19403 | United States |
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Hospitals and medical clinics
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| ID | Title | Description |
|---|---|---|
| FG000 | Ferric Carboxymaltose (FCM) | Subjects received an undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg) or subjects received 200 mg of FCM IV push undiluted directly into the venous line of the dialyzer. |
| FG001 | Standard Medical Care (SMC) | SMC for IDA (as determined by the Investigator) for treating CKD related anemia. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Safety population - of the 517 total subjects randomized, 4 subjects randomized to FCM were discontinued from the study prior to dosing due to selection critirea/study compliance (3 subjects) and subject request (1 subject)
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| ID | Title | Description |
|---|---|---|
| BG000 | Ferric Carboxymaltose (FCM) | Subjects received an undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg) or subjects received 200 mg of FCM IV push undiluted directly into the venous line of the dialyzer. |
| BG001 | Standard Medical Care (SMC) |
| 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 | Incidence of Treatment-emergent Serious Adverse Events (SAE's) | Posted | Number | participants | from Day 0 through 30 days after the last dose of study drug |
|
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 | Ferric Carboxymaltose (FCM) | Subjects received an undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg) or subjects received 200 mg of FCM IV push undiluted directly into the venous line of the dialyzer. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial flutter | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark 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 |
|---|---|
| C522335 | ferric carboxymaltose |
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| Drug |
|
SMC for IDA (as determined by the Investigator) for treating CKD related anemia. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
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| 11 |
| 254 |
| 0 |
| 254 |
| EG001 | Standard Medical Care (SMC) | SMC for IDA (as determined by the Investigator) for treating CKD related anemia. | 36 | 259 | 0 | 259 |
| Hypovolemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Osteomyelitis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Sepsis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
| Myocardial infarction | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| Coronary artery disease | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| Ascities | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Hydrothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Localized infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
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| Catheter related complication | General disorders | CTCAE (3.0) | Systematic Assessment |
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| Ventricular fibrillation | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| Vitreous hemorrhage | Eye disorders | CTCAE (3.0) | Systematic Assessment |
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| Thromboembolic stroke | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
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| Clostridial infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| Azotemia | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
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| Acute myocardial infarction | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| Metabolic acidosis | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
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| Gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Pneumonia | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Angina pectoris | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
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| Hypertension | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
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| Urosepsis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| Renal failure | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
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| Cellulitis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
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| Catheter sepsis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
|
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