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Clinical Trial Details

Trial ID: L0040
Source ID: NCT00701714
Associated Drug: Hx575 Recombinant Human Erythropoietin Alfa
Title: Randomized, Controlled, Double-blind Multicenter Safety Study to Evaluate the Safety and Immunogenicity of Subcutaneous EPO HEXAL vs. ERYPO® in the Treatment of Anemia Associated With Chronic Renal Insufficiency in Predialysis Patients
Acronym:
Status: TERMINATED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT00701714/results
Conditions: Anemia|Chronic Renal Insufficiency
Interventions: DRUG: HX575 recombinant human erythropoietin alfa|DRUG: ERYPO
Outcome Measures: Primary: Change in Hemoglobin Level, Mean absolute change in hemoglobin (baseline to end of study week 13), 13 weeks|Weekly Epoetin Dose, Mean weekly epoetin dose \[IU/kg\] in study weeks 11-13, weeks 11-13 | Secondary: Immunogenicity, Number of participants with antibody formation against Epoetin during treatment period (safety set), 13 weeks
Sponsor/Collaborators: Sponsor: Sandoz
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 337
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2007-09
Completion Date: 2010-01
Results First Posted: 2018-02-05
Last Update Posted: 2018-02-05
Locations: Diakonissen KH Salzburg, Salzburg, 5020, Austria|LKH Steyr, Steyr, 4400, Austria|Krankenanstalt der Stadt Wien, Wien, 1030, Austria|AKH Wien, Wien, 1090, Austria|Sozialmedizinisches Zentrum Ost Donauspital, Wien, 1220, Austria|MHAT Pazardijk, Pazardzhik, 4400, Bulgaria|MHAT Sveti Ivan Rilski, Sofia, 1431, Bulgaria|MHAT Stara Zagora, Stara Zagora, 6003, Bulgaria|MHAT "Sv. Anna", Varna, 9002, Bulgaria|Ambulance vnitrního lékarstvi, Brno, 61500, Czechia|Nemocnice Kladno, Kladno, 27259, Czechia|Litomyslska nemocnice, a.s., Litomyšl, 57014, Czechia|Nemocnice s poliklinikou v Novem Jicine, Novi Jicin, 741 01, Czechia|Dialcorp, s.r.o., Praha 4 - Michle, 140 00, Czechia|IKEM, Praha 4, 14021, Czechia|FN Motol, Praha 5, 15006, Czechia|Nemocnice Prostìjov, Prostìjov, 79604, Czechia|Nemocnice Šternberk, Šternberk, 78501, Czechia|Nefrologická a interní amb., Žïár n. Sázavou, 591 01, Czechia|CHU d'Amiens - Hopital Sud, Amiens, 80054, France|CHU de Rouen - Hopital de Bois Guillaume, Bois-Guillaume, 76230, France|Gesundheitszentrum Alzey, Alzey, 55232, Germany|Studienzentrum Hämatologie / Onkologie / Diabetes, Aschaffenburg, 63739, Germany|Gemeinschaftspraxis Dr. med. Gert-Peter Dragoun, Dr. med Günther Hevendehl, Aschaffenburg, 63741, Germany|Nephrologische Praxis Bad Münder, Bad Münder, 31848, Germany|Praxis Dr. Scharla, Bad Reichenhall, 83435, Germany|Nephrologisches Zentrum an Stadtkrankenhaus, Bad Wildungen, 34537, Germany|Dialyse-Centrum, Bad Windsheim, 91438, Germany|KfH Kuratorium f. Dialyse und Nierentransplantation e.V., Bergisch Gladbach, 51465, Germany|Schwerpunktpraxis für Diabetologie und Nephrologie, Bernkastel-Kues, 54470, Germany|KfH Kuratorium für Dialyse und Nierentransplantation e.V., Bischofswerda, 01877, Germany|Nephrologische Gemeinschaftspraxis Dr. Rensinghoff & Dr. Becker, Bochum-Wattenscheid, 44866, Germany|Dialysepraxis drs. Riedasch/Schreiber, Coesfeld, 48653, Germany|Praxis Dr. Kraatz, Demmin, 17109, Germany|Gemeinschaftspraxis Dr. Steffen & Dr. Perino, Dinkelsbühl, 91550, Germany|Diabetes- und Dialysezentrum Merker, Vogt, Dormagen, 41539, Germany|Gemeinschaftspraxis Karlstraße, Düsseldorf, 40210, Germany|Dialysepraxis Häger, Schanze, Brause, Düsseldorf, 40211, Germany|KfH Kuratorium f. Dialyse und Nierentransplantation e.V., Eberswalde, 16225, Germany|Gemeinschaftspraxis Dr. Spitthöver, Dr. Knee, Dr. Gröschel, Essen, 45127, Germany|Praxis Dr. Zimmermann, Essen, 45136, Germany|Praxis Dr. Lüdemann, Falkensee, 14612, Germany|Dialysepraxis, Friedrichroda, 99894, Germany|KfH Kuratorium für Dialyse und Nierentransplantation e.V., Fürstenzell, 94081, Germany|Dialysepraxis Barmbek, Hamburg, 22297, Germany|KfH Kuratorium für Dialyse und Nierentransplantation e.V., Haßfurt, 97437, Germany|KfH Kuratorium für Dialyse und Nierentransplantation e.V., Heringen, 36266, Germany|Dialysezentrum, Homberg/Efze, 34576, Germany|Gemeinschaftspraxis und Dialyse, Hürth, 50354, Germany|Dialyseplaxis DR. Rieck, DR. Göbel, DR. Wagner, Krefeld, 47798, Germany|Leipziger Institut für Präventivmedizin, Leipzig, 04103, Germany|Med Center Leipzig, Leipzig, 04107, Germany|GDG Gemeinnützige Dialyse Gesellschaft, Leverkusen, 51373, Germany|KfH Kuratorium für Dialyse und Nierentransplantation e.V., Ludwigshafen, 67059, Germany|Gemeinschaftspraxis Dres. Leistikow, Hafezi und Sandner, Mannheim, 68309, Germany|Praxis Dr. Schütterle, Marburg, 35043, Germany|Praxis Dr. Vogel-Wagner, Mittweida, 09648, Germany|Praxis Dr. Rose, Pohlmeier und Dr. Lammers, Münster, 48145, Germany|Dialyse Nettetal, Nettetal, 41334, Germany|KfH Kuratorium für dialyse und Nierentransplantation e.V., Nördlingen, 86720, Germany|KfH Kuratorium für Dialyse und Nierentransplantation e.V., Passau, 94032, Germany|Praxis Dipl. med. Kosch, Pirna, 01796, Germany|Dialysepraxis Dipl. med. Gierak & Dipl. med. Rettig, Quedlinburg, 06484, Germany|Klinik für Nephrologie und Allgemeine Innere Medizin, Solingen, 42653, Germany|KfH Kuratorium für Dialyse und Nierentransplantation e.V., Straubing, 94315, Germany|Gemeinschaftspraxis Dr. Kirchner und Dr. Menge, Sömmerda, 99610, Germany|Praxis Dr. med. Mauersberger, Villingen-Schwenningen, 78054, Germany|Kamineni Hospitals Ltd., Hyderabaad, 500068, India|NIZAM Institute of Medical Sciences, Hyderabaad, 500082, India|Bombay Hospital, Indore, 452010, India|Monilek Hospital and Research Center, Jaipur, 302004, India|Vinaya Hospital & Research Centre, Mangalore, 575003, India|Pulse Diagnostix Cardiac and Medical Center, Pune, 411001, India|Kerala Institute of Medical Sciences, Trivandrum, 695029, India|SP ZOZ Miejski Szpital Zespolony, Czestochowa, 42200, Poland|Specjalistyczna Przychodnia Lekarska Medikard, Plock, 09-402, Poland|Szpital Wojewódzki w Poznaniu, Poznan, 60-479, Poland|Specjalistyczne Centrum Diagnostyczno-Lecznicze Bamberski Dwor (Solumed SC), Poznan, 60-539, Poland|NZOZ NEFROLUX Sp. J. Lucjan Sobieraj, Wojciech Kaminski, Siemianowice Slaskie, 41100, Poland|Wojewodzki Szpital Specjalistyczny nr. 1 im. Jozefa Gasinskiego, Tychy, 43-100, Poland|Szpital Praski p.w. Przemienienia Panskiego II Oddzia Chorob Wewnetrznych, Warszawa, 03401, Poland|NZOZ Centrum Badan Klinicznych, Wroclaw, 50-349, Poland|Centrul Medical de Diagnostic si Tratament Ambulator si Medicina Preventiva Bucuresti, Bucuresti, 011794, Romania|Institutul National de DiabetNutritie si Boli Metabolice Paulescu, Bucuresti, 020475, Romania|Institutul Clinic Fundeni, Bucuresti, 022328, Romania|Spitalul Universitar Bucuresti, Bucuresti, 050098, Romania|Spitalul Clinic Judetean Cluj, Cluj, 400 006, Romania|County Hospital Deva, Deva, 330084, Romania|Spitalul Clinic CI Parhon Iasi, Iasi, 700503, Romania|Dr. Gavril Curteanu Clinical Hospital, Oradea, 410469, Romania|County Hospital Tg Mures, Tg Mures, 540103, Romania|SC Medicali's SRL, Timisoara, 300359, Romania|Emergency Clinical County Hospital, Timisoara, 300736, Romania|Spitalul Judetean Timisoara, Timisoara, 300736, Romania|Policlinica Dr. Citu, Timisoara, 300766, Romania|Municipal medical Institution "City Hospital #1", Barnaul, 656099, Russian Federation|Municipal Institution "City Clinical Hospital #40", Ekaterinburg, 620102, Russian Federation|State Healthcare Institution "Sverdlovsk Regional Clinical Hospital #1", Ekaterinburg, 620102, Russian Federation|State Healthcare Institution "Kemerova Regional Clinical Hospital", Kemerovo, 650066, Russian Federation|Federal State Institution "National Medical Surgery center named after NI Pirogov of Federal Agency of Health Care and Social Development", Moscow, 105203, Russian Federation|State Educational Institution of Higher Professional Education "Moscow State University of Medicine and dentistry of Federal Agency of health Care and Social Development", City Clinical Hospital #23, Moscow, 109240, Russian Federation|Russian University of Peoples Frienship (clinical base: City clinical hospital #53), Moscow, 115432, Russian Federation|State Health Care Institution City Clinical Hospital named after SP Botkin, Moscow, 125284, Russian Federation|State healthcare Institution "Nizhegorodsky Regional Clinical Hospital named after NA Semashko", Nizhniy Novgorod, 603126, Russian Federation|State Healthcare Institution "Reoublic Hospital named after VA Baranov", Petrozavodsk, 185019, Russian Federation|Municipal healthcare Institution "City Clinical Hospital #2", Pyatigorsk, 357538, Russian Federation|State Healthcare Institution "Ryazan Regional Cardiological Dispensary", Ryazan, 390026, Russian Federation|State Educational Institution of High Professional Education Saratov State Medical University of Roszdrav, Saratov, 410053, Russian Federation|State Educational Institution of Higher Professional Education "Smolensk State Medical Academy of Federal Agency of Health Care and Social Development", Smolensk, 214018, Russian Federation|State Educational Institution of Higher Professional Education "St. Petersburg State Medical Academy for Postgraduate studies of Roszdrav", St. Petersburg, 191015, Russian Federation|St. Petersburg State Healthcare Institution "City Mariinsky Hospital", St. Petersburg, 191104, Russian Federation|State Institution "St. petersburg Clinical research Institute of Emergency Medical Care named after I.I. Dzhanelidze", St. petersburg, 192242, Russian Federation|St. Petersburg State Healthcare Institution "City Outpatient Clinic #17", St. petersburg, 194358, Russian Federation|State Educational Institution of Higher Professional Education "St. Petersburg State Medical Academy named after I.I. Mechnikov of Roszdrav", St. Petersburg, 195067, Russian Federation|State Institute St. Petersburg, St. Petersburg, 195067, Russian Federation|State Educational Institution of Higher Professional Education "St. Petersburg State Medical Institute named after IP Pavlov of Roszdrav", St. Petersburg, 197022, Russian Federation|State Institution Scientific Research Institute of Cardiology of Tomsk Research Center of Siberian Branch of Russian Academy of Medical Sciences, Tomsk, 634012, Russian Federation|SibMedCenter LLC, Tomsk, 634041, Russian Federation|Municipal Healthcare Institution "City Clinical Hospital #2", Yaroslavl, 150010, Russian Federation|State Healthcare Institution of Yaroslavl region "Regional Clinical Hosptal", Yaroslavl, 150062, Russian Federation|SMOLKO s.r.o., Kosice, 04001, Slovakia|MEDIKOL s.r.o., Košice, 040 01, Slovakia|FN Trnava, Trnava, 917 75, Slovakia
URL: https://clinicaltrials.gov/show/NCT00701714