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Clinical Trial Details

Trial ID: L1453
Source ID: NCT00450333
Associated Drug: Dynepo (Epoetin Delta)
Title: Dynepo Infrequent Dosing Study
Acronym:
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00450333/results
Conditions: Anemia|Kidney Failure
Interventions: DRUG: Dynepo (Epoetin delta)|DRUG: Dynepo|DRUG: Dynepo|DRUG: Dynepo
Outcome Measures: 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., 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., week 16 and 24|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
Sponsor/Collaborators: Sponsor: Shire
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 407
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2006-10-30
Completion Date: 2008-07-31
Results First Posted: 2009-11-10
Last Update Posted: 2021-06-14
Locations: Med.Univ-Klinik/Klin. Abt.f.Nephrologie u. Hamodialyse, Graz, Steiemark, A-8036, Austria|Univ.-Klinik für Innere Medizin/Klin. Abt. für Nephrologie, Innsbruck, A-6020, Austria|Hopital UCL, Service de Nephrologie, Bruxelles, 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 Cedex, 33076, France|CH de Boulogne-sur-mer (Hopital de Dr Duchenne), Boulogne-sur-mer, 62321, France|Hopital Clemenceau, Nephrologie-Hemodialyse, Caen Cedex 5, 14033, France|CHU (Centre Hospitalier Universitaire), Grenoble Cedex 9, 38043, France|CHU Hotel Dieu, Service du Pr Soulillou, Nantes Cedex 1, 44093, France|Clinique de Landy, Service de Nephrologie - Hemodialyse, Saint-Ouen, 93400, France|Hopital Sud, Service du Pr Fournier, Salouel, 80480, France|CHU Hopital Civil, Nephrologie-Hemodialyse, Strasbourg Cedex, 67091, France|Hopital Rangueil, Service du Pr Durand, Toulouse Cedex 4, 31403, France|Hopital Brabois Adultes, Nephrologie, Vandoeuvre Les Nancy, 54511, France|Nephrologische Zentrum Villingen-Schwenningen, Villingen-Schwenningen, Baden-Wurttemberg, 78054, Germany|KfH Nierenzebtrum im Linikum Rosenheim, Rosenheim, Bavern, 83022, Germany|KfH Nierenzentrum Bamberg, Bamberg, Bayern, 96050, Germany|Dialyse-und Apheresezentrum Potsdam-Bebelsberg, Potsdam, Brandenburg, 14482, Germany|KfH Nierenzentrum Fulda, Fulda, Hessen, 36043, Germany|KfH Nierenzentrum am Handr-Klinikum Stralsund, Stralsund, Mecklenburg-Vorpommern, 18435, Germany|Praxis Dr. Vosskuhler, Bottrop, Nordrhein Westfalen, 46242, Germany|Gemeinschaftspraxis Prof. Mann/Prof. Heidenreich, Aachen, Nordrhein-Westfalen, 52074, Germany|Nephrologische Gemeinschaftspraxis, Dialysezentrum Karlstrabe, Dusseldorf, Nordrhein-Westfalen, 40210, Germany|KfK Nierenzentrum Nurnberg, Nurnberg, 90471, Germany|Universita' degli Studi di Napoli Federico II, Napoli, 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, Roma, Lazio, 00184, Italy|Spedali Civil Brescia, Brescia, Lombardia, 25123, Italy|Ospedale Nuovo Alessandro Manzoni, Lecco, Lombardia, 23900, Italy|Azienda Ospedaliera CTO/CRF/M.Adelaide, Torino, Piemonte, 10126, Italy|Ospedali Riuniti, Foggia, Puglia, 71100, Italy|A.R.N.A.S Civico Palermo, Palermo, Sicilia, 90127, Italy|Azienda Sanitaria Locale 4 Area Pratese, Prato, Toscana, 59100, Italy|Hospital Puerto Real, Puerto Real, Cadiz, 11510, Spain|Hotel General Universitario, Castelló de la Plana, 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, Cordoba, 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
URL: https://clinicaltrials.gov/show/NCT00450333

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress