A Study of Monthly Subcutaneous Continuous Erythropoietin Receptor Activator (CERA) in Predialysis Participants With Chronic Renal Anemia
NCT ID: NCT00773968
Last Updated: 2016-04-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
140 participants
INTERVENTIONAL
2008-09-30
2010-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Methoxy Polyethylene Glycol-Epoetin Beta
Participants will receive methoxy polyethylene glycol-epoetin beta once monthly by subcutaneous (SC) injection for 28 weeks.
Methoxy Polyethylene Glycol-Epoetin Beta
120, 200 or 360 micrograms every 4 weeks by subcutaneous injection.
Interventions
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Methoxy Polyethylene Glycol-Epoetin Beta
120, 200 or 360 micrograms every 4 weeks by subcutaneous injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Continuous subcutaneous maintenance darbopoetin alfa treatment during previous month;
* Hb concentration between 10 and 12 g/dL;
* Adequate iron status.
Exclusion Criteria
* Significant acute or chronic bleeding, such as overt gastrointestinal bleeding;
* Poorly controlled hypertension requiring hospitalization or interruption of darbopoetin alfa treatment in the previous 6 months;
* Active malignant disease.
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Barletta, Apulia, Italy
Molfetta (Ba), Apulia, Italy
Putignano, Apulia, Italy
Caserta, Campania, Italy
Eboli, Campania, Italy
Napoli, Campania, Italy
Nola, Campania, Italy
Solofra, Campania, Italy
Tivoli, Campania, Italy
Bologna, Emilia-Romagna, Italy
Pordenone, Friuli Venezia Giulia, Italy
Albano Laziale, Lazio, Italy
Civita Castellana, Lazio, Italy
Viterbo, Lazio, Italy
Savona, Liguria, Italy
Cinisello Balsamo, Lombardy, Italy
Cremona, Lombardy, Italy
Mantova, Lombardy, Italy
Monza, Lombardy, Italy
Pavia, Lombardy, Italy
S Fermo Della Battaglia, Lombardy, Italy
Varese, Lombardy, Italy
Campobasso, Molise, Italy
Alessandria, Piedmont, Italy
Chivasso, Piedmont, Italy
Catania, Sicily, Italy
Erice, Sicily, Italy
Messina, Sicily, Italy
Palermo, Sicily, Italy
Ancona, The Marches, Italy
Pesaro, The Marches, Italy
Lido di Camaiore, Tuscany, Italy
Pistoia, Tuscany, Italy
Siena, Tuscany, Italy
Countries
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Other Identifiers
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2008-003173-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ML21439
Identifier Type: -
Identifier Source: org_study_id
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