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To assess the change in hemoglobin levels when iron sucrose was added to a regimen of weekly, fixed doses of erythropoietin in patients who had or had not responded to erythropoietin therapy alone.
This was a two stage, randomized, controlled study of cancer patients undergoing or planning to undergo chemotherapy. After stage one, (where patients were exposed to an erythropoiesis stimulating agent), patients were randomized to receive either IV iron sucrose or no iron supplementation. Patients were then followed to safety and efficacy endpoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Venofer + erythropoietin (responders) | Active Comparator |
| |
| erythropoietin only (responders) | Active Comparator |
| |
| Venofer+erythropoietin(non-responders) | Active Comparator |
| |
| erythropoietin only (non-responders) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iron sucrose injection USP | Drug |
| ||
| stable erythropoietin therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to the Maximum Hemoglobin Level During Stage 2 (Week 9 Through Week 21). | The hemoglobin baseline was defined as the average of the last 2 hemoglobin values during stage 1 (through week 8). | During Stage 2 (week 9 through week 21) |
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Inclusion Criteria:
Exclusion Criteria:
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Anemia defined as a hemoglobin level < or = to 10.0 g/dL.
July 18, 2003 - October 27, 2005 Locations: Hospitals and Medical Clinics (33 total sites)
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A: Erythropoietin + Venofer (Responders) | Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2. |
| FG001 | Group B: Erythropoietin Only (Responders) | Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin only. |
| FG002 | Group C: Erythropoietin + Venofer (Non-responders) | Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2. |
| FG003 | Group D: Erythropoietin Only (Non-responders) | Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin only. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A: Erythropoietin + Venofer (Responders) | Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2. |
| 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 | Change From Baseline to the Maximum Hemoglobin Level During Stage 2 (Week 9 Through Week 21). | The hemoglobin baseline was defined as the average of the last 2 hemoglobin values during stage 1 (through week 8). | intention to treat (ITT) | Posted | Mean | Standard Deviation | g/dL | During Stage 2 (week 9 through week 21) |
|
2 years and 3 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 | Group A: Erythropoietin + Venofer (Responders) | Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain NOS | Gastrointestinal disorders | MedDRA (6.0) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain NOS | Gastrointestinal disorders | MedDRA (6.0) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark A. Falone, MD | Luitpold Pharmaceuticals | 610-650-4200 | 844 | mfalone@luitpold.com |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Drug |
|
| BG001 |
| Group B: Erythropoietin Only (Responders) |
Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin only. |
| BG002 | Group C: Erythropoietin + Venofer (Non-responders) | Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2. |
| BG003 | Group D: Erythropoietin Only (Non-responders) | Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin only. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin only. |
| OG002 | Group C: Erythropoietin + Venofer (Non-responders) | Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2. |
| OG003 | Group D: Erythropoietin Only (Non-responders) | Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin only. |
|
|
| 13 |
| 59 |
| 50 |
| 59 |
| EG001 | Group B: Erythropoietin Only (Responders) | Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin only. | 14 | 77 | 48 | 77 |
| EG002 | Group C: Erythropoietin + Venofer (Non-responders) | Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2. | 11 | 40 | 32 | 40 |
| EG003 | Group D: Erythropoietin Only (Non-responders) | Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin only. | 11 | 48 | 35 | 48 |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (6.0) |
|
| Abscess limb | Infections and infestations | MedDRA (6.0) |
|
| Asthenia | General disorders | MedDRA (6.0) |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (6.0) |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (6.0) |
|
| Bronchitis acute NOS | Infections and infestations | MedDRA (6.0) |
|
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (6.0) |
|
| Cerebral haemorrhage | Nervous system disorders | MedDRA (6.0) |
|
| Cerebrovascular accident | Nervous system disorders | MedDRA (6.0) |
|
| Chest pain | General disorders | MedDRA (6.0) |
|
| Chronic obstructive airways disease exacerbated | Respiratory, thoracic and mediastinal disorders | MedDRA (6.0) |
|
| Colostomy | Surgical and medical procedures | MedDRA (6.0) |
|
| Deep vein thrombosis | Vascular disorders | MedDRA (6.0) |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (6.0) |
|
| Diplopia | Eye disorders | MedDRA (6.0) |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (6.0) |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (6.0) |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (6.0) |
|
| Fatigue | General disorders | MedDRA (6.0) |
|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (6.0) |
|
| Femur Fracture | Injury, poisoning and procedural complications | MedDRA (6.0) |
|
| Headache | Nervous system disorders | MedDRA (6.0) |
|
| Hemoglobin decreased | Investigations | MedDRA (6.0) |
|
| Hip fracture | Injury, poisoning and procedural complications | MedDRA (6.0) |
|
| Hypersensitivity NOS | Immune system disorders | MedDRA (6.0) |
|
| Hypokalemia | Metabolism and nutrition disorders | MedDRA (6.0) |
|
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (6.0) |
|
| Hypotension NOS | Vascular disorders | MedDRA (6.0) |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (6.0) |
|
| Intestinal obstruction NOS | Gastrointestinal disorders | MedDRA (6.0) |
|
| Leukopenia NOS | Blood and lymphatic system disorders | MedDRA (6.0) |
|
| Malaise | General disorders | MedDRA (6.0) |
|
| Malignant neoplasm NOS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (6.0) |
|
| Myocardial infarction | Cardiac disorders | MedDRA (6.0) |
|
| Nausea | Gastrointestinal disorders | MedDRA (6.0) |
|
| Neutropenia | Blood and lymphatic system disorders | MedDRA (6.0) |
|
| Orthostatic hypotension | Vascular disorders | MedDRA (6.0) |
|
| Pancreatic carcinoma metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (6.0) |
|
| Pancreatitis NOS | Gastrointestinal disorders | MedDRA (6.0) |
|
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (6.0) |
|
| Peripheral neuropathy NOS | Nervous system disorders | MedDRA (6.0) |
|
| Pneumonia NOS | Infections and infestations | MedDRA (6.0) |
|
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (6.0) |
|
| Pneumothorax NOS | Respiratory, thoracic and mediastinal disorders | MedDRA (6.0) |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (6.0) |
|
| Pyrexia | General disorders | MedDRA (6.0) |
|
| Rectal hemorrhage | Gastrointestinal disorders | MedDRA (6.0) |
|
| Rectal neoplasm NOS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (6.0) |
|
| Resection of Rectum | Surgical and medical procedures | MedDRA (6.0) |
|
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (6.0) |
|
| Sepsis NOS | Infections and infestations | MedDRA (6.0) |
|
| Septic Shock | Infections and infestations | MedDRA (6.0) |
|
| Small intestinal obstruction NOS | Gastrointestinal disorders | MedDRA (6.0) |
|
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (6.0) |
|
| Status epilepticus | Nervous system disorders | MedDRA (6.0) |
|
| Urinary retention | Renal and urinary disorders | MedDRA (6.0) |
|
| Urinary tract infection NOS | Infections and infestations | MedDRA (6.0) |
|
| Vaginectomy | Surgical and medical procedures | MedDRA (6.0) |
|
| Vomiting NOS | Gastrointestinal disorders | MedDRA (6.0) |
|
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (6.0) |
|
| Anorexia | Metabolism and nutrition disorders | MedDRA (6.0) |
|
| Appetite decreased NOS | Metabolism and nutrition disorders | MedDRA (6.0) |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (6.0) |
|
| Asthenia | General disorders | MedDRA (6.0) |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (6.0) |
|
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA (6.0) |
|
| Canidal infection NOS | Infections and infestations | MedDRA (6.0) |
|
| Chest pain | General disorders | MedDRA (6.0) |
|
| Constipation | Gastrointestinal disorders | MedDRA (6.0) |
|
| Contusion | Skin and subcutaneous tissue disorders | MedDRA (6.0) |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA (6.0) |
|
| Depression | Psychiatric disorders | MedDRA (6.0) |
|
| Diarrhea NOS | Gastrointestinal disorders | MedDRA (6.0) |
|
| Dizziness | Nervous system disorders | MedDRA (6.0) |
|
| Dysgeusia | Nervous system disorders | MedDRA (6.0) |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (6.0) |
|
| Dyspnea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (6.0) |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (6.0) |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (6.0) |
|
| Fatigue | General disorders | MedDRA (6.0) |
|
| Haematuria | Renal and urinary disorders | MedDRA (6.0) |
|
| Headache | Nervous system disorders | MedDRA (6.0) |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (6.0) |
|
| Hypokalemia | Metabolism and nutrition disorders | MedDRA (6.0) |
|
| Hypotension NOS | Vascular disorders | MedDRA (6.0) |
|
| Insomnia | Psychiatric disorders | MedDRA (6.0) |
|
| Muscle cramp | Musculoskeletal and connective tissue disorders | MedDRA (6.0) |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (6.0) |
|
| Nausea | Gastrointestinal disorders | MedDRA (6.0) |
|
| Oedema NOS | General disorders | MedDRA (6.0) |
|
| Oedema peripheral | General disorders | MedDRA (6.0) |
|
| Pain NOS | General disorders | MedDRA (6.0) |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (6.0) |
|
| Paraesthesia | Nervous system disorders | MedDRA (6.0) |
|
| Peripheral neuropathy NOS | Nervous system disorders | MedDRA (6.0) |
|
| Prothrombin time prolonged | Investigations | MedDRA (6.0) |
|
| Pyrexia | General disorders | MedDRA (6.0) |
|
| Rash NOS | Skin and subcutaneous tissue disorders | MedDRA (6.0) |
|
| Stomatitis | Gastrointestinal disorders | MedDRA (6.0) |
|
| Upper respiratory infection NOS | Infections and infestations | MedDRA (6.0) |
|
| Vomiting NOS | Gastrointestinal disorders | MedDRA (6.0) |
|
| Weight decreased | Investigations | MedDRA (6.0) |
|
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