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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 | 750 mg of iron as undiluted FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg per minute weekly until the calculated iron deficit dose has been administered (to a maximum cumulative dose of 2,250 mg). |
|
| Standard Medical Care (SMC) for the treatment of IDA | Active Comparator | SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferric Carboxymaltose (FCM) | Drug |
| ||
| Standard Medical Care (SMC) for the treatment of IDA |
| Measure | Description | Time Frame |
|---|---|---|
| Safety, as Defined by the Occurence of Serious Adverse Events (SAE's), of FCM Compared to SMC | Safety, as defined by the occurence of serious adverse events (SAE's), of FCM compared to SMC in the treatment of IDA in subjects who were not dialysis dependent | First administration of FCM, or Day 0 for SMC subjects, through end of study (Day 42) or 28 days after the last dose of study drug (FCM or SMC) whichever was longer |
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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 |
5 subjects randomized into the trial were discontinued prior to dosing.
Hospitals and medical clinics
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| ID | Title | Description |
|---|---|---|
| FG000 | Ferric Carboxymaltose (FCM) | 750 mg of iron as undiluted FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg per minute weekly until the calculated iron deficit dose has been administered (to a maximum cumulative dose of 2,250 mg). |
| FG001 | Standard Medical Care (SMC) for the Treatment of IDA | SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ferric Carboxymaltose (FCM) | 750 mg of iron as undiluted FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg per minute weekly until the calculated iron deficit dose has been administered (to a maximum cumulative dose of 2,250 mg). |
| BG001 | Standard Medical Care (SMC) for the 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 | Safety, as Defined by the Occurence of Serious Adverse Events (SAE's), of FCM Compared to SMC | Safety, as defined by the occurence of serious adverse events (SAE's), of FCM compared to SMC in the treatment of IDA in subjects who were not dialysis dependent | Posted | Number | participants | First administration of FCM, or Day 0 for SMC subjects, through end of study (Day 42) or 28 days after the last dose of study drug (FCM or SMC) whichever was longer |
|
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) | 750 mg of iron as undiluted FCM (15 mg/kg up to a maximum of 750 mg) at 100 mg per minute weekly until the calculated iron deficit dose has been administered (to a maximum cumulative dose of 2,250 mg). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) |
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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 |
|---|---|
| C522335 | ferric carboxymaltose |
| D026661 | Clinical Trials Data Monitoring Committees |
| ID | Term |
|---|---|
| D011367 | Professional Staff Committees |
| D011785 | Quality Assurance, Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Drug |
|
SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA). |
| 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 |
|
SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA). |
|
|
| 17 |
| 343 |
| 41 |
| 343 |
| EG001 | Standard Medical Care (SMC) for the Treatment of IDA | SMC as determined by the Investigator for the treatment of iron deficiency anemia (IDA). | 11 | 360 | 71 | 360 |
| Atrial fibrillation | Cardiac disorders | CTCAE (3.0) |
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| Coronary artery disease | Cardiac disorders | CTCAE (3.0) |
|
| Meniere's disease | Ear and labyrinth disorders | CTCAE (3.0) |
|
| Abdominal pain lower | Gastrointestinal disorders | CTCAE (3.0) |
|
| Ascites | Gastrointestinal disorders | CTCAE (3.0) |
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| Constipation | Gastrointestinal disorders | CTCAE (3.0) |
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| Gastric ulcer | Gastrointestinal disorders | CTCAE (3.0) |
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| Gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE (3.0) |
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| Hemorrhoids | Gastrointestinal disorders | CTCAE (3.0) |
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| Chest pain | General disorders | CTCAE (3.0) |
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| Cellulitis | Infections and infestations | CTCAE (3.0) |
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| Femur fracture | Injury, poisoning and procedural complications | CTCAE (3.0) |
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| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (3.0) |
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| Back pain | Musculoskeletal and connective tissue disorders | CTCAE (3.0) |
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| Breast cancer in situ | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) |
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| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) |
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| Rectal cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) |
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| Cartoid artery stenosis | Nervous system disorders | CTCAE (3.0) |
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| Facial palsy | Nervous system disorders | CTCAE (3.0) |
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| Renal failure acute | Renal and urinary disorders | CTCAE (3.0) |
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| Renal infarct | Renal and urinary disorders | CTCAE (3.0) |
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| Menorrhagia | Reproductive system and breast disorders | CTCAE (3.0) |
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| Hypertensive crisis | Vascular disorders | CTCAE (3.0) |
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| Hypotension | Vascular disorders | CTCAE (3.0) |
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| Nausea | Gastrointestinal disorders | CTCAE (3.0) |
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| Headache | Nervous system disorders | CTCAE (3.0) |
|
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