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| ID | Type | Description | Link |
|---|---|---|---|
| 2007-000054-31 | EudraCT Number |
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The termination of the study is not linked to a product recall or result of any safety signal. Rather it was sponsor's commercial decision to withdraw the MA
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To assess the incidence rate of Treatment Emergent Adverse Events (TEAEs) over 2 years in patients treated with Dynepo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dynepo (Epoetin delta) | Experimental | Subjects received Dynepo (Epoetin delta) either twice weekly (BIW), once weekly (QW), once every 2 weeks (Q2W) or once every 4 weeks (Q4W) based on what is appropriate for the subject |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dynepo | Drug | Subcutaneous injection either BIW, QW, Q2W or Q4W based on what is appropriate for the subject |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Emergence of Treatment Emergent Adverse Events (TEAEs) | Over the course of 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin (Hb) Concentrations at 2 Years | Baseline and 2 years | |
| Change From Baseline in Hematocrits at 2 Years | Baseline and 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Heilig Hartziekenhuis Department of Nephrology | Lier | Belgium |
Subjects received Dynepo (Epoetin delta) either twice weekly (BIW), once weekly (QW), once every 2 weeks (Q2W) or once every 4 weeks (Q4W) at a dose that is appropriate for them and not to exceed 20,000 IU at any one time.
This study was terminated on July 31, 2008 as a result of a decision by Shire Pharmaceutical to permanently cease marketing Dynepo and withdraw the Marketing Authorisation. The decision was for commercial reasons, it was not the result of any safety signal.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dynepo (Epoetin Delta) Twice Weekly (BIW) | Epoetin delta (Dynepo) dosed twice-a-week |
| FG001 | Dynepo Once Weekly (QW) | Epoetin delta dosed once-a-week |
| FG002 | Dynepo Once Every 2 Weeks (Q2W) | Epoetin delta dosed once every 2 weeks |
| FG003 | Dynepo Once Every 4 Weeks (Q4W) | Epoetin delta dosed once every 4 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dynepo (Epoetin Delta) Twice Weekly (BIW) | Epoetin delta (Dynepo) dosed twice-a-week |
| BG001 | Dynepo Once Weekly (QW) | Epoetin delta dosed once-a-week |
| 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 | Rate of Emergence of Treatment Emergent Adverse Events (TEAEs) | This study was terminated on July 31, 2008 as a result of a decision by Shire Pharmaceutical to permanently cease marketing Dynepo and withdraw the Marketing Authorisation. The decision was for commercial reasons, it was not the result of any safety signal. | Posted | Over the course of 2 Years |
|
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The adverse events were collected on the Safety Population defined as all subjects randomized who received at least one dose of Dynepo. Therefore, 150 of the 152 enrolled subjects constituted the Safety Population. Therefore, the second Arm has 84 subjects instead of 86 as shown in the participant flow.
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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 | Dynepo (Epoetin Delta) Twice Weekly (BIW) | Epoetin delta (Dynepo) dosed twice-a-week |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute MI | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
This study terminated early due to a decision by Shire Pharmaceuticals to permanently cease marketing Dynepo due to commercial reasons, it was not the result of any safety signal. Not enough subjects completed the study to do any efficacy analyses.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
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| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| C516023 | epoetin delta |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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| Adverse Event |
|
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Lack of Efficacy |
|
| Kidney transplant |
|
| Death |
|
| BG002 | Dynepo Once Every 2 Weeks (Q2W) | Epoetin delta dosed once every 2 weeks |
| BG003 | Dynepo Once Every 4 Weeks (Q4W) | Epoetin delta dosed once every 4 weeks |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Epoetin delta dosed once every 2 weeks |
| OG003 | Dynepo Once Every 4 Weeks (Q4W) | Epoetin delta dosed once every 4 weeks |
|
| Secondary | Change From Baseline in Hemoglobin (Hb) Concentrations at 2 Years | This study was terminated on July 31, 2008 as a result of a decision by Shire Pharmaceutical to permanently cease marketing Dynepo and withdraw the Marketing Authorisation. The decision was for commercial reasons, it was not the result of any safety signal. | Posted | Baseline and 2 years |
|
|
| Secondary | Change From Baseline in Hematocrits at 2 Years | This study was terminated on July 31, 2008 as a result of a decision by Shire Pharmaceutical to permanently cease marketing Dynepo and withdraw the Marketing Authorisation. The decision was for commercial reasons, it was not the result of any safety signal. | Posted | Baseline and 2 years |
|
|
| 1 |
| 15 |
| 7 |
| 15 |
| EG001 | Dynepo Once Weekly (QW) | Epoetin delta dosed once-a-week | 14 | 84 | 62 | 84 |
| EG002 | Dynepo Once Every 2 Weeks (Q2W) | Epoetin delta dosed once every 2 weeks | 6 | 47 | 32 | 47 |
| EG003 | Dynepo Once Every 4 Weeks (Q4W) | Epoetin delta dosed once every 4 weeks | 1 | 4 | 4 | 4 |
| Angina pectoris | Cardiac disorders | Non-systematic Assessment |
|
| Cardiac failure | Cardiac disorders | Non-systematic Assessment |
|
| Coronary artery stenosis | Cardiac disorders | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | Non-systematic Assessment |
|
| Fecaloma | Gastrointestinal disorders | Non-systematic Assessment |
|
| Hematemesis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Peritonitis | Gastrointestinal disorders | Non-systematic Assessment |
|
| Catheter-related complication | General disorders | Non-systematic Assessment |
|
| Sudden death | General disorders | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | Non-systematic Assessment |
|
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Dialysis device complication | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Splenic rupture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Traumatic fracture | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Hyperglycemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Non-systematic Assessment |
|
| Edema peripheral | General disorders | Non-systematic Assessment |
|
| Vessel puncture site hematoma | General disorders | Non-systematic Assessment |
|
| Catheter site infection | Infections and infestations | Non-systematic Assessment |
|
| Influenza | Infections and infestations | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | Non-systematic Assessment |
|
| Pneumonia | Infections and infestations | Non-systematic Assessment |
|
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Dialysis device complication | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Injury | Injury, poisoning and procedural complications | Non-systematic Assessment |
|
| Hemaglobin decreased | Investigations | Non-systematic Assessment |
|
| Hyperphosphatemia | Metabolism and nutrition disorders | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Bronchitis chronic | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hydrothorax | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Alopecia | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Dermatitis allergic | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | Non-systematic Assessment |
|
| Orthostatic hypertension | Vascular disorders | Non-systematic Assessment |
|
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
| D007674 | Kidney Diseases |
| 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 |
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |