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The primary objective of this study is to evaluate the long term safety and tolerability of an iron maintenance dosing strategy utilizing VIT45 in the treatment of anemia of non-dialysis dependent chronic kidney disease (NDD-CKD). This study is a long term extension to protocol 1VIT04004 (NCT00317239).
The primary objective of this study is to evaluate the long term safety and tolerability of an iron maintenance dosing strategy utilizing VIT45 in the treatment of anemia of non-dialysis dependent chronic kidney disease (NDD-CKD). This study is a long term extension to protocol 1VIT04004.
In this study patients that complete protocol 1VIT 04004 or are discontinued will be offered to participate in this extension study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ferric Carboxymaltose (FCM) | Experimental | maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ferric Carboxymaltose (FCM) | Drug | maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-emergent Adverse Events | 44 week study duration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Luitpold Pharmaceuticals Inc. | Norristown | Pennsylvania | 19403 | United States |
no treatment with FCM in the trial excluded 18 subjects from the Safety population
Hospitals and medical clinics
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| ID | Title | Description |
|---|---|---|
| FG000 | Ferric Carboxymaltose (FCM) | maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit based on TSAT and Ferritin levels |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ferric Carboxymaltose (FCM) | maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit based on TSAT and Ferritin levels |
| 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 Adverse Events | Posted | Number | each event | 44 week study duration |
|
|
1 year and 8 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) | maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit based on TSAT and Ferritin levels |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | CTCAE (3.0) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Odema peripheral | General 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 |
| 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 |
|---|---|
| C522335 | ferric carboxymaltose |
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 23 |
| 127 |
| 23 |
| 127 |
| Angina unstable | Cardiac disorders | CTCAE (3.0) |
|
| Coronary artery disease | Cardiac disorders | CTCAE (3.0) |
|
| Abdominal pain | Gastrointestinal disorders | CTCAE (3.0) |
|
| Gastrointestinal hemorrhage | Gastrointestinal disorders | CTCAE (3.0) |
|
| Large intestine perforation | Gastrointestinal disorders | CTCAE (3.0) |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) |
|
| Rectal hemorrhage | Gastrointestinal disorders | CTCAE (3.0) |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) |
|
| Chest pain | General disorders | CTCAE (3.0) |
|
| Drug hypersensitivity | Immune system disorders | CTCAE (3.0) |
|
| Cellulitis | Infections and infestations | CTCAE (3.0) |
|
| Localized infection | Infections and infestations | CTCAE (3.0) |
|
| Pyelonephritis | Infections and infestations | CTCAE (3.0) |
|
| Urinary tract infection | Infections and infestations | CTCAE (3.0) |
|
| Femur fracture | Injury, poisoning and procedural complications | CTCAE (3.0) |
|
| Foot fracture | Injury, poisoning and procedural complications | CTCAE (3.0) |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | CTCAE (3.0) |
|
| Localized osteoarthritis | Musculoskeletal and connective tissue disorders | CTCAE (3.0) |
|
| Synovitis | Musculoskeletal and connective tissue disorders | CTCAE (3.0) |
|
| Anoxic encephalopathy | Nervous system disorders | CTCAE (3.0) |
|
| Headache | Nervous system disorders | CTCAE (3.0) |
|
| Azotemia | Renal and urinary disorders | CTCAE (3.0) |
|
| Urinary tract obstruction | Renal and urinary disorders | CTCAE (3.0) |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
|
| Respiratory distress | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | CTCAE (3.0) |
|
| Deep vein thrombosis | Vascular disorders | CTCAE (3.0) |
|
| Lymphoedema | Vascular disorders | CTCAE (3.0) |
|
| Urinary tract infection | Infections and infestations | CTCAE (3.0) |
|
| Hypertension | Vascular 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 |