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This study compares the efficacy and safety of intravenous (IV) iron (VIT45) versus oral iron (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with non-dialysis dependent chronic kidney disease (NDD-CKD).
This study compares the efficacy and safety of intravenous (IV) iron (VIT45) versus oral iron (ferrous sulfate) administered to subjects who suffer from anemia and are diagnosed with non-dialysis dependent chronic kidney disease (NDD-CKD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferric Carboxymaltose (FCM) | Experimental | A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values. |
|
| Ferrous Sulfate tablets | Active Comparator | 325 mg/TID x 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferrous Sulfate tablets | Drug | 325 mg/TID x 8 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Achieving an Increase in Hemoglobin ≥1g/dL | anytime during the study |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20929915 | Result | Qunibi WY, Martinez C, Smith M, Benjamin J, Mangione A, Roger SD. A randomized controlled trial comparing intravenous ferric carboxymaltose with oral iron for treatment of iron deficiency anaemia of non-dialysis-dependent chronic kidney disease patients. Nephrol Dial Transplant. 2011 May;26(5):1599-607. doi: 10.1093/ndt/gfq613. Epub 2010 Oct 7. | |
| Result | Qunibi W, Martinez C, Smith M, Benjamin J, Dinh Q. A Randomized Controlled Trial Comparing IV Ferric Carboxymaltose (FCM) to Oral Iron in Anemic Patients with Non-Dialysis-Dependent CKD. American Society of Nephrology Renal Week 2007. |
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Hospitals and medical clinics
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| ID | Title | Description |
|---|---|---|
| FG000 | Ferric Carboxymaltose (FCM) | A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values. |
| FG001 | Ferrous Sulfate Tablets | 325 mg/TID x 8 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ferric Carboxymaltose (FCM) | A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values. |
| BG001 | Ferrous Sulfate Tablets |
| 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 Subjects Achieving an Increase in Hemoglobin ≥1g/dL | Modified Intent to Treat (mITT) population defined as subjects who received at least 1 dose of study medication, had stable EPO for at least 8 weeks prior to randomization, had at least 1 post-baseline hemoglobin assessment, and who had NDD-CKD characterized by a GFR ≤45 mL/min/1.73² | Posted | Number | participants | anytime during the study |
|
1 year and 9 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) | A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac failure congestive | Cardiac 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 Falone | Luitpold Pharmaceuticals, Inc. | 610-650-4200 | 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 |
|---|---|
| D007505 | Iron-Dextran Complex |
| C522335 | ferric carboxymaltose |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
| D003911 | Dextrans |
| D005936 | Glucans |
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| Ferric Carboxymaltose (FCM) |
| Drug |
A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values. |
|
325 mg/TID x 8 weeks
| 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 |
|
|
|
| 13 |
| 147 |
| 11 |
| 147 |
| EG001 | Ferrous Sulfate Tablets | 325 mg/TID x 8 weeks | 10 | 103 | 20 | 103 |
| Coronary artery disease | Cardiac disorders | CTCAE (3.0) |
|
| Myocardial infarction | Cardiac disorders | CTCAE (3.0) |
|
| Myocardial ischemia | Cardiac disorders | CTCAE (3.0) |
|
| Palpitations | Cardiac disorders | CTCAE (3.0) |
|
| Gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE (3.0) |
|
| Intestinal hemorrhage | Gastrointestinal disorders | CTCAE (3.0) |
|
| Pancreatitis acute | Gastrointestinal disorders | CTCAE (3.0) |
|
| Cellulitis | Infections and infestations | CTCAE (3.0) |
|
| Sepsis | Infections and infestations | CTCAE (3.0) |
|
| Skin infection | Infections and infestations | CTCAE (3.0) |
|
| Upper respiratory tract infection | Infections and infestations | CTCAE (3.0) |
|
| Polytraumatism | Injury, poisoning and procedural complications | CTCAE (3.0) |
|
| Postoperative fever | Injury, poisoning and procedural complications | CTCAE (3.0) |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) |
|
| Ovarian cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) |
|
| Cerebrovascular accident | Nervous system disorders | CTCAE (3.0) |
|
| Glomerulonephritis proliferative | Renal and urinary disorders | CTCAE (3.0) |
|
| Renal failure chronic | Renal and urinary disorders | CTCAE (3.0) |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
|
| Odema peripheral | General disorders | CTCAE (3.0) |
|
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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 |
| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |