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Clinical Trial Details

Trial ID: L0997
Source ID: NCT01121237
Associated Drug: Recombinant Human Erythropoietin Alfa (Biosimilar)
Title: MONITOR-CKD5 - Multi-level Evaluation of Anaemia Treatment, Outcomes, and Determinants in Chronic Kidney Disease Stage 5
Acronym: MONITOR-CKD5
Status: COMPLETED
Study Results: NO
Results:
Conditions: Chronic Kidney Disease|End-stage Renal Disease|Anaemia
Interventions: DRUG: Recombinant human erythropoietin alfa (biosimilar)
Outcome Measures: Primary: Haemoglobin outcomes, including haemoglobin levels in g/dL, change in haemoglobin levels over time (in g/dL and %), number and proportion of patients with haematopoietic response, number and proportion of patients reaching target haemoglobin levels., every month for 24 months | Secondary: Number and proportion of participants with thrombovascular events, hospitalization,and mortality as measures of safety., Safety will be assessed every month for 24 months. In addition, any safety events reported by the patient or observed by clinicians in-between the monthly assessments will be recorded at the time of report or occurrence, and will be addressed at that time as necessary., Every month for 24 months + as occurring between visits
Sponsor/Collaborators: Sponsor: Sandoz | Collaborators: Hexal AG
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 2086
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2010-02
Completion Date: 2014-11
Results First Posted:
Last Update Posted: 2016-04-06
Locations: Sandoz Investigational Site, Bregenz, Austria|Sandoz Investigational Site, Eisenstadt, Austria|Sandoz Investigational Site, Feldkirch, Austria|Sandoz Investigational Site, Nenzing, Austria|Sandoz Investigational Site, Vienna, Austria|Sandoz Investigational Site, Ajaccio, France|Sandoz Investigational Site, Dourlers, France|Sandoz Investigational Site, Fourmies Cedex, France|Sandoz Investigational Site, Lille, France|Sandoz Investigational Site, St. Quentin, France|Sandoz Investigational Site, Alsfeld, Germany|Sandoz Investigational Site, Arnstadt, Germany|Sandoz Investigational Site, Bad Neustadt a. d. Saale, Germany|Sandoz Investigational Site, Bassum, Germany|Sandoz Investigational Site, Berlin, Germany|Sandoz Investigational Site, Bochum, Germany|Sandoz Investigational Site, Cloppenburg, Germany|Sandoz Investigational Site, Cochem, Germany|Sandoz Investigational Site, Darmstadt, Germany|Sandoz Investigational Site, Dresden, Germany|Sandoz Investigational Site, Duisburg, Germany|Sandoz Investigational Site, Düsseldorf, Germany|Sandoz Investigational Site, Erftstadt, Germany|Sandoz Investigational Site, Georgsmarienhütte, Germany|Sandoz Investigational Site, Greifswald, Germany|Sandoz Investigational Site, Güstrow, Germany|Sandoz Investigational Site, Herne, Germany|Sandoz Investigational Site, Herzberg, Germany|Sandoz Investigational Site, Hoyerswerda, Germany|Sandoz Investigational Site, Höchstadt, Germany|Sandoz Investigational Site, Kamen, Germany|Sandoz Investigational Site, Kiel, Germany|Sandoz Investigational Site, Magdeburg, Germany|Sandoz Investigational Site, Mettmann, Germany|Sandoz Investigational Site, Munich, Germany|Sandoz Investigational Site, Nürnberg, Germany|Sandoz Investigational Site, Osnabrück, Germany|Sandoz Investigational Site, Pinneberg, Germany|Sandoz Investigational Site, Quedlinburg, Germany|Sandoz Investigational Site, Remagen, Germany|Sandoz Investigational Site, Rendsburg, Germany|Sandoz Investigational Site, Schrobenhausen, Germany|Sandoz Investigational Site, Schwabach, Germany|Sandoz Investigational Site, Seehausen, Germany|Sandoz Investigational Site, Viersen, Germany|Sandoz Investigational Site, Wetzlar, Germany|Sandoz Investigational Site, Wilhelmshaven, Germany|Sandoz Investigational Site, Acireale, Italy|Sandoz Investigational Site, Altamura, Italy|Sandoz Investigational Site, Arenzano, Italy|Sandoz Investigational Site, Arezzo, Italy|Sandoz Investigational Site, Biella, Italy|Sandoz Investigational Site, Catania, Italy|Sandoz Investigational Site, Chivasso, Italy|Sandoz Investigational Site, Cinisello Balsamo, Italy|Sandoz Investigational Site, Cirié, Italy|Sandoz Investigational Site, Cosenza, Italy|Sandoz Investigational Site, Cuneo, Italy|Sandoz Investigational Site, Ivrea, Italy|Sandoz Investigational Site, Montevarchi, Italy|Sandoz Investigational Site, Pavia, Italy|Sandoz Investigational Site, Pontecorvo, Italy|Sandoz Investigational Site, Putignano, Italy|Sandoz Investigational Site, Roma, Italy|Sandoz Investigational Site, Torino, Italy|Sandoz Investigational Site, Bialystok, Poland|Sandoz Investigational Site, Ciechanów, Poland|Sandoz Investigational Site, Gdańsk, Poland|Sandoz Investigational Site, Lublin, Poland|Sandoz Investigational Site, Poznań, Poland|Sandoz Investigational Site, Rzeszów, Poland|Sandoz Investigational Site, Wołomin, Poland|Sandoz Investigational Site, Bistrita, Romania|Sandoz Investigational Site, Braila, Romania|Sandoz Investigational Site, Brasov, Romania|Sandoz Investigational Site, Bucharest, Romania|Sandoz Investigational Site, Miercurea Ciuc, Romania|Sandoz Investigational Site, Odorheiu Secuiesc, Romania|Sandoz Investigational Site, Resita, Romania|Sandoz Investigational Site, Roman, Romania|Sandoz Investigational Site, TG. Jiu, Romania|Sandoz Investigational Site, Maribor, Slovenia|Sandoz Investigational Site, San Pietro, Slovenia|Sandoz Investigational Site, Avila, Spain|Sandoz Investigational Site, León, Spain|Sandoz Investigational Site, Sevilla, Spain|Sandoz Investigational Site, Zamora, Spain|Sandoz Investigational Site, Fribourg, Switzerland|Sandoz Investigational Site, Lausanne, Switzerland|Sandoz Investigational Site, Nyon, Switzerland|Sandoz Investigational Site, Zürich, Switzerland|Sandoz Investigational Site, Cambridge, United Kingdom|Sandoz Investigational Site, Chester, United Kingdom|Sandoz Investigational Site, Norwich, United Kingdom|Sandoz Investigational Site, Plymouth, United Kingdom
URL: https://clinicaltrials.gov/show/NCT01121237

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress