A Study of Subcutaneous C.E.R.A. for the Maintenance of Hemoglobin Levels in Participants With Chronic Renal Anemia Not on Dialysis.
NCT ID: NCT00642304
Last Updated: 2018-06-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
20 participants
INTERVENTIONAL
2008-03-27
2009-12-09
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
methoxy polyethylene glycol-epoetin beta [C.E.R.A.]
Methoxy polyethylene glycol-epoetin beta is administered SC every four week up to Week 20.The starting dose is 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta participants shall be receiving in the week preceding the study start. Further dose adjustment during the study depending on the hemoglobin (Hb) values.
Interventions
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methoxy polyethylene glycol-epoetin beta [C.E.R.A.]
Methoxy polyethylene glycol-epoetin beta is administered SC every four week up to Week 20.The starting dose is 120, 200 or 300 mcg based on the dose of darbepoetin alfa or epoetin beta participants shall be receiving in the week preceding the study start. Further dose adjustment during the study depending on the hemoglobin (Hb) values.
Eligibility Criteria
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Inclusion Criteria
* Stable darbepoetin alfa or epoetin beta therapy for past 8 weeks
Exclusion Criteria
* Poorly controlled hypertension requiring interruption of epoetin treatment in previous 6 months
* Acute or chronic bleeding requiring therapy within previous 8 weeks
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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Twenteborg Ziekenhuis
Almelo, , Netherlands
Meander Mc, Locatie Lichtenberg; Dept of Lung Diseases
Amersfoort, , Netherlands
Bovenij Zkhs; Cardiologie Afd.
Amsterdam, , Netherlands
Wilhelmina Ziekenhuis; Inwendige Geneeskunde
Assen, , Netherlands
Rode Kruis Ziekenhuis; Inwendige Geneeskunde
Beverwijk, , Netherlands
Amphia Ziekenhuis
Breda, , Netherlands
Reinier De Graaf Groep
Delft, , Netherlands
Slingeland Ziekenhuis; Inwendige Geneeskunde
Doetinchem, , Netherlands
Albert Schweitzer Ziekenhuis; Inwendige Geneeskunde
Dordrecht, , Netherlands
Nij Smellinghe Ziekenhuis; Inwendige Geneeskunde
Drachten, , Netherlands
Oosterscheldeziekenhuis
Goes, , Netherlands
Groene Hart Ziekenhuis Bleulandlocatie; Inwendige Geneeskunde
Gouda, , Netherlands
Atrium Medisch Centrum; Nephrology
Heerlen, , Netherlands
Bethesda Hospital; Internal Medicine
Hoogeveen, , Netherlands
Leiden University Medical Center; Nierziekten
Leiden, , Netherlands
Rijnland Zkhs Loc Leiderdorp; Interne geneeskunde
Leiderdorp, , Netherlands
Academish Ziekenhuis Maastricht (Azm); Inwendige Geneeskunde
Maastricht, , Netherlands
Academisch Ziekenhuis St. Radboud; Nierziekten Afd.
Nijmegen, , Netherlands
Erasmus Mc - Locatie Centrum; Inwendige Geneeskunde
Rotterdam, , Netherlands
Mc Rijnmond Zuid - Locatie Clara; Infectieziekten
Rotterdam, , Netherlands
Ikazia Ziekenhuis; Interne Oncologie
Rotterdam, , Netherlands
Zorgsaam Ziekenhuis
Terneuzen, , Netherlands
Diakonessenhuis
Utrecht, , Netherlands
Countries
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Other Identifiers
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ML20937
Identifier Type: -
Identifier Source: org_study_id
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