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The objective of this study is to evaluate the safety of FCM in patients with anemia who are not dialysis dependent
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferric Carboxymaltose (FCM) | Experimental | 15 mg/kg up to a maximum of 750 mg at 100 mg/minute intravenously on Day 0. |
|
| Standard Medical Care | Active Comparator | Per product label |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferric Carboxymaltose | Drug | 15 mg/kg up to a maximum of 750 mg at 100 mg/minute intravenously on Day 0. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Serious Adverse Events (SAE's) | through 30 days after the last dose of study drug (FCM or SMC for the treatment of IDA) |
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Inclusion Criteria:
Exclusion 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 receieved an undiluted dose of iron as FCM (15mg/kg up to a maximum of 750 mg) at 100 mg/minute on Day 0. |
| FG001 | Standard Medical Care | Subjects received standard medical care (as determined by the Investigator) for treatment of IDA. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ferric Carboxymaltose (FCM) | Subjects receieved an undiluted dose of iron as FCM (15mg/kg up to a maximum of 750 mg) at 100 mg/minute on Day 0. |
| BG001 | Standard Medical Care | Subjects received standard medical care (as determined by the Investigator) for treatment of IDA. |
| 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 | Number of Participants With Treatment-emergent Serious Adverse Events (SAE's) | Posted | Number | participants | through 30 days after the last dose of study drug (FCM or SMC for the treatment of IDA) |
|
|
1 year
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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 (15 mg/kg up to a maximum of 750 mg) at 100 mg/minute on Day 0. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Iron deficiency anemia | Blood and lymphatic system disorders | CTCAE (3.0) |
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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 |
| C020748 | ferrous sulfate |
| D000077605 | Ferric Oxide, Saccharated |
| C035552 | ferric gluconate |
| D007505 | Iron-Dextran Complex |
| ID | Term |
|---|---|
| D005290 | Ferric Compounds |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
| D005937 | Glucaric Acid |
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| Standard Medical Care (SMC) | Drug | Per product label |
|
|
| BG002 | 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 |
|
| Participants |
|
|
| 5 |
| 366 |
| 0 |
| 366 |
| EG001 | Standard Medical Care | Received standard medical care (as determined by the Investigator) of IDA. | 9 | 369 | 0 | 369 |
| Leukocytosis | Blood and lymphatic system disorders | CTCAE (3.0) |
|
| Angina pectoris | Cardiac disorders | CTCAE (3.0) |
|
| Atrial fibrillation | Cardiac disorders | CTCAE (3.0) |
|
| Cardiomyopathy | Cardiac disorders | CTCAE (3.0) |
|
| Coronary artery disease | Cardiac disorders | CTCAE (3.0) |
|
| Food poisoning | Gastrointestinal disorders | CTCAE (3.0) |
|
| Gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE (3.0) |
|
| Pyrexia | General disorders | CTCAE (3.0) |
|
| Pneumonia | Infections and infestations | CTCAE (3.0) |
|
| Inappropriate device stimulation of tissue | Injury, poisoning and procedural complications | CTCAE (3.0) |
|
| Dehydration | Metabolism and nutrition disorders | CTCAE (3.0) |
|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | CTCAE (3.0) |
|
| Neuropathy | Nervous system disorders | CTCAE (3.0) |
|
| Renal failure acute | Renal and urinary disorders | CTCAE (3.0) |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
|
| Hypertension | Vascular disorders | CTCAE (3.0) |
|
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| D013400 |
| Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
| D056831 | Coordination Complexes |
| D003911 | Dextrans |
| D005936 | Glucans |
| D011134 | Polysaccharides |