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| ID | Type | Description | Link |
|---|---|---|---|
| 2006-002052-15 | EudraCT Number |
Not provided
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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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The purpose of this study is to demonstrate non-inferiority of efficacy between twice weekly and once weekly dose schedule of Dynepo in previously erythropoietin (EPO)-naive patients, as measured by haemoglobin at week 24 and secondly to demonstrate the non-inferiority of efficacy between once weekly and once every two weeks dose schedules of Dynepo in patients previously stable on EPO, as measured by Hb over Weeks 16 to 24.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Erythropoietin(EPO)-naive BIW |
|
| 2 | Active Comparator | EPO-naive QW |
|
| 3 | Active Comparator | EPO QW |
|
| 4 | Active Comparator | EPO Q2W |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dynepo (Epoetin delta) | Drug | subcutaneous, BIW for 24 weeks |
| |
| Dynepo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Hemoglobin (Hb) Concentration at 24 Weeks | 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. | Baseline and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Who Achieve Hb Levels of > or Equal to 11 g/dL | 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. | week 16 and 24 |
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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 |
|---|---|---|---|---|---|---|
| Med.Univ-Klinik/Klin. Abt.f.Nephrologie u. Hamodialyse | Graz | Steiemark | A-8036 | Austria | ||
| Univ.-Klinik für Innere Medizin/Klin. Abt. für Nephrologie |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36791280 | Derived | Chung EY, Palmer SC, Saglimbene VM, Craig JC, Tonelli M, Strippoli GF. Erythropoiesis-stimulating agents for anaemia in adults with chronic kidney disease: a network meta-analysis. Cochrane Database Syst Rev. 2023 Feb 13;2(2):CD010590. doi: 10.1002/14651858.CD010590.pub3. | |
| 17999759 | Derived | Macdougall IC. Comparison of different dosing regimens (once weekly vs. twice weekly, and once weekly vs. once every two weeks) with epoetin delta in patients with chronic kidney disease: a randomized controlled trial. Trials. 2007 Nov 13;8:35. doi: 10.1186/1745-6215-8-35. |
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Erythropoietin (EPO)-naive subjects were randomized to receive Dynepo (Epoetin delta) once weekly (QW) or twice weekly (BIW) and subjects who were already stable on EPO (doses < or equal to 10,000 IU/week) were randomized to receive Dynepo once every 2 weeks (Q2W) or once weekly.
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. Not enough subjects completed the study to do any efficacy analyses.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Dynepo (Epoetin Delta)-Naive Once-weekly (QW) | Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW) |
| FG001 | Dynepo-naive Twice-weekly (BIW) | EPO-naive subjects receiving Epoetin delta twice weekly (BIW) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
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| Drug |
subcutaneous, QW for 24 weeks |
|
| Dynepo | Drug | subcutaneous, QW for 24 weeks |
|
| Dynepo | Drug | subcutaneous, Q2W for 24 weeks |
|
| Change From Baseline in Hematocrits at 16 and 24 Weeks |
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. |
| Baseline and Weeks 16 and 24 |
| Innsbruck |
| A-6020 |
| Austria |
| Hopital UCL, Service de Nephrologie | Brussels | B-1200 | Belgium |
| UZ Gasthuisberg, Leuve, Dept of Nephrology | Leuven | B-3000 | Belgium |
| Hellig Hart Ziekenhuis, Campus Wilgenstraat | Roeselare | B-8800 | Belgium |
| CHU - Hopital Pellegrin, Nephrologie-Hemodialyse | Bordeaux | 33076 | France |
| CH de Boulogne-sur-mer (Hopital de Dr Duchenne) | Boulogne-sur-Mer | 62321 | France |
| Hopital Clemenceau, Nephrologie-Hemodialyse | Caen | 14033 | France |
| CHU (Centre Hospitalier Universitaire) | Grenoble | 38043 | France |
| CHU Hotel Dieu, Service du Pr Soulillou | Nantes | 44093 | France |
| Clinique de Landy, Service de Nephrologie - Hemodialyse | Saint-Ouen | 93400 | France |
| Hopital Sud, Service du Pr Fournier | Salouël | 80480 | France |
| CHU Hopital Civil, Nephrologie-Hemodialyse | Strasbourg | 67091 | France |
| Hopital Rangueil, Service du Pr Durand | Toulouse | 31403 | France |
| Hopital Brabois Adultes, Nephrologie | Vandœuvre-lès-Nancy | 54511 | France |
| Nephrologische Zentrum Villingen-Schwenningen | Villingen-Schwenningen | Baden-Wurttemberg | 78054 | Germany |
| KfH Nierenzentrum Bamberg | Bamberg | Bavaria | 96050 | Germany |
| KfH Nierenzebtrum im Linikum Rosenheim | Rosenheim | Bavern | 83022 | Germany |
| Dialyse-und Apheresezentrum Potsdam-Bebelsberg | Potsdam | Brandenburg | 14482 | Germany |
| KfH Nierenzentrum Fulda | Fulda | Hesse | 36043 | Germany |
| KfH Nierenzentrum am Handr-Klinikum Stralsund | Stralsund | Mecklenburg-Vorpommern | 18435 | Germany |
| Gemeinschaftspraxis Prof. Mann/Prof. Heidenreich | Aachen | North Rhine-Westphalia | 52074 | Germany |
| Praxis Dr. Vosskuhler | Bottrop | North Rhine-Westphalia | 46242 | Germany |
| Nephrologische Gemeinschaftspraxis, Dialysezentrum Karlstrabe | Düsseldorf | North Rhine-Westphalia | 40210 | Germany |
| KfK Nierenzentrum Nurnberg | Nuremberg | 90471 | Germany |
| Ospedali Riuniti | Foggia | Apulia | 71100 | Italy |
| Universita' degli Studi di Napoli Federico II | Naples | Campania | 80131 | Italy |
| Policlinico S. Orsola Malpighi | Bologna | Emilia-Romagna | 40138 | Italy |
| Azienda Ospedaliera Universitaria Policlinico di Modena | Modena | Emillia Romagna | 41100 | Italy |
| Azienda Ospedaliera S.Giovanni-Addolorata | Rome | Lazio | 00184 | Italy |
| Spedali Civil Brescia | Brescia | Lombardy | 25123 | Italy |
| Ospedale Nuovo Alessandro Manzoni | Lecco | Lombardy | 23900 | Italy |
| Azienda Ospedaliera CTO/CRF/M.Adelaide | Turin | Piedmont | 10126 | Italy |
| A.R.N.A.S Civico Palermo | Palermo | Sicily | 90127 | Italy |
| Azienda Sanitaria Locale 4 Area Pratese | Prato | Tuscany | 59100 | Italy |
| Hospital Puerto Real | Puerto Real | Cadiz | 11510 | Spain |
| Hotel General Universitario | Castellon | Castellon | 120004 | Spain |
| Head of Nephrology, Fundacion Puigvert | Barcelona | 08025 | Spain |
| Hospital Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clinic i Provincial | Barcelona | 08036 | Spain |
| Hospital Universitario Reina Sofia | Córdoba | 14004 | Spain |
| Hospital Gregorio Maranon | Madrid | 28007 | Spain |
| Hospital Central de Asturias | Oviedo | 33006 | Spain |
| Hospital Universitario Marques de Valdecilla | Santander | 39008 | Spain |
| Hospital Doctor Peset | Valencia | 46017 | Spain |
| Hope Hospital | Salford | Manchester | M6 8HD | United Kingdom |
| Richard Bright Renal Unit Southmead Hospital | Bristol | BS10 5NB | United Kingdom |
| Addenbrooke's Hospital | Cambridge | CB2 0QQ | United Kingdom |
| University Hospital of Wales | Cardiff | CF14 4XW | United Kingdom |
| Glasgow Western Infirmary | Glasgow | G11 6NT | United Kingdom |
| Kings College Hospital Renal Unit | London | SE5 9RS | United Kingdom |
| Morrison Hospital | Swansea | SA6 6NL | United Kingdom |
| New Cross Hospital | Wolverhampton | WV10 0QP | United Kingdom |
| FG002 | Dynepo Once Every 2 Weeks (Q2W) | EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W) |
| FG003 | Dynepo QW | EPO stable subjects receiving Epoetin delta once weekly (QW) |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Dynepo (Epoetin Delta)-Naive Once-weekly (QW) | Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW) |
| BG001 | Dynepo-naive Twice-weekly (BIW) | EPO-naive subjects receiving Epoetin delta twice weekly (BIW) |
| BG002 | Dynepo Once Every 2 Weeks (Q2W) | EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W) |
| BG003 | Dynepo QW | EPO stable subjects receiving Epoetin delta once weekly (QW) |
| BG004 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | 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 in Hemoglobin (Hb) Concentration at 24 Weeks | 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. | 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. | Posted | Baseline and 24 weeks |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Patients Who Achieve Hb Levels of > or Equal to 11 g/dL | 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. | 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. | Posted | week 16 and 24 |
| |||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Hematocrits at 16 and 24 Weeks | 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. | 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. | Posted | Baseline and Weeks 16 and 24 |
|
Not provided
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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)-Naive Once-weekly (QW) | Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW) | 15 | 98 | 59 | 98 | ||
| EG001 | Dynepo-naive Twice-weekly (BIW) | EPO-naive subjects receiving Epoetin delta twice weekly (BIW) | 23 | 107 | 50 | 107 | ||
| EG002 | Dynepo Once Every 2 Weeks (Q2W) | EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W) | 23 | 100 | 44 | 100 | ||
| EG003 | Dynepo QW | EPO stable subjects receiving Epoetin delta once weekly (QW) | 20 | 102 | 44 | 102 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| DIC | Blood and lymphatic system disorders | Non-systematic Assessment |
| ||
| Acute coronary syndrome | Cardiac disorders | Non-systematic Assessment |
| ||
| Acute MI | Cardiac disorders | Non-systematic Assessment |
| ||
| Cardiac failure | Cardiac disorders | Non-systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Colitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Gastrointestinal hemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Peritonitis | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Pneumonia | Infections and infestations | Non-systematic Assessment |
| ||
| Hemoglobin decreased | Investigations | Non-systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Brain stem hemorrhage | Nervous system disorders | Non-systematic Assessment |
| ||
| Cerebrovascular accident | Nervous system disorders | Non-systematic Assessment |
| ||
| Hypoglycemic coma | Nervous system disorders | Non-systematic Assessment |
| ||
| Restless legs syndrome | Nervous system disorders | Non-systematic Assessment |
| ||
| Pulmonary edema | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Hypertension | Vascular disorders | Non-systematic Assessment |
| ||
| Angina | Cardiac disorders | Non-systematic Assessment |
| ||
| Renal failure | Renal and urinary disorders | Non-systematic Assessment |
| ||
| Cardiac arrest | Cardiac disorders | Non-systematic Assessment |
| ||
| Coronary artery disease | Cardiac disorders | Non-systematic Assessment |
| ||
| Tachycardia | Cardiac disorders | Non-systematic Assessment |
| ||
| Ischemic cardiomyopathy | Cardiac disorders | Non-systematic Assessment |
| ||
| Intercranial hemorrhage | Nervous system disorders | Non-systematic Assessment |
| ||
| Thrombosis | Vascular disorders | Non-systematic Assessment |
| ||
| Hypotension | Vascular disorders | Non-systematic Assessment |
| ||
| Hemorrhage | Vascular disorders | Non-systematic Assessment |
| ||
| Peripheral ischemia | Vascular disorders | Non-systematic Assessment |
| ||
| Arterial occlusive disease | Vascular disorders | Non-systematic Assessment |
| ||
| Atrial fibrillation | Cardiac disorders | Non-systematic Assessment |
| ||
| Duodenal ulcer hemorrhage | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Intestinal fistula | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Catheter related complication | General disorders | Non-systematic Assessment |
| ||
| Catheter thrombosis | General disorders | Non-systematic Assessment |
| ||
| Catheter related infection | Infections and infestations | Non-systematic Assessment |
| ||
| Sepsis | Infections and infestations | Non-systematic Assessment |
| ||
| Pyelonephritis | Infections and infestations | Non-systematic Assessment |
| ||
| Arteriovenous fistula complication | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Fluid overload | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Orthopnea | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Edema peripheral | General disorders | Non-systematic Assessment |
| ||
| Bronchitis | Infections and infestations | Non-systematic Assessment |
| ||
| Influenza | Infections and infestations | Non-systematic Assessment |
| ||
| Hyperkalemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Hyperphosphatemia | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Iron deficiency | Metabolism and nutrition disorders | Non-systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Muscle spasms | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
| ||
| Headache | Nervous system disorders | Non-systematic Assessment |
| ||
| Cough | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Hypertension | Vascular disorders | Non-systematic Assessment |
| ||
| Hypotension | Vascular 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.
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D051437 | Renal Insufficiency |
| D000092122 | Bronchiolitis Obliterans Syndrome |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D000092124 | Organizing Pneumonia |
| D001989 | Bronchiolitis Obliterans |
| D001988 | Bronchiolitis |
| D001991 | Bronchitis |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D006086 | Graft vs Host Disease |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004921 | Erythropoietin |
| C516023 | epoetin delta |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| 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 |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Spain |
|
| Belgium |
|
| Austria |
|
| Germany |
|
| United Kingdom |
|
| Italy |
|
| Australia |
|
| Hungary |
|
| Latvia |
|
| Lithuania |
|
| New Zealand |
|
EPO stable subjects receiving Epoetin delta once weekly (QW)
|
EPO stable subjects receiving Epoetin delta once weekly (QW)
|