A Study of Subcutaneous Mircera in Participants With Chronic Kidney Disease Not Treated With ESA or on Dialysis
NCT ID: NCT00559637
Last Updated: 2016-04-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
184 participants
INTERVENTIONAL
2008-01-31
2010-06-30
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 will be administered subcutaneously once a month. The starting dose will be 1.2 mcg/kg of body weight. Further dose adjustments will be performed during the study depending on the hemoglobin value. Total duration of treatment will be 9 months for all participants in the study and up to 11 months for participants who will be shifted to the dialysis.
Methoxy polyethylene glycol-epoetin beta
Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously once a month. The starting dose will be 1.2 mcg/kg of body weight. Further dose adjustments will be performed during the study depending on the hemoglobin value. Total duration of treatment will be 9 months for all participants in the study and up to 11 months for participants who will be shifted to the dialysis.
Interventions
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Methoxy polyethylene glycol-epoetin beta
Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously once a month. The starting dose will be 1.2 mcg/kg of body weight. Further dose adjustments will be performed during the study depending on the hemoglobin value. Total duration of treatment will be 9 months for all participants in the study and up to 11 months for participants who will be shifted to the dialysis.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* hemoglobin value less than or equal to (\<=) 10.5 grams/deciliter (g/dL).
Exclusion Criteria
* acute or chronic bleeding requiring therapy during previous 2 months;
* transfusion of red blood cells during previous 2 months;
* active malignant disease (except non-melanoma skin cancer).
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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Ansbach, , Germany
Arnsberg, , Germany
Bad Aibling, , Germany
Berlin, , Germany
Bischofswerda, , Germany
Bonn, , Germany
Cologne, , Germany
Cologne, , Germany
Dieburg, , Germany
Dortmund, , Germany
Düsseldorf, , Germany
Emsdetten, , Germany
Frankfurt, , Germany
Friedberg, , Germany
Grimma, , Germany
Hamburg, , Germany
Hamburg, , Germany
Heidelberg, , Germany
Hilden, , Germany
Homburg, , Germany
Hoyerswerda, , Germany
Jena, , Germany
Kaiserslautern, , Germany
Loerrach, , Germany
Ludwigslust, , Germany
Lübeck, , Germany
Lünen, , Germany
Mainz, , Germany
Malente, , Germany
Mettmann, , Germany
Mühlacker, , Germany
München, , Germany
Regensburg, , Germany
Rheine, , Germany
Saarlouis, , Germany
Schwandorf in Bayern, , Germany
Schweinfurt, , Germany
Sindelfingen, , Germany
Sinsheim, , Germany
Tangermünde, , Germany
Trier, , Germany
Tübingen, , Germany
Ulm, , Germany
Velbert, , Germany
Wetzlar, , Germany
Wiesloch, , Germany
Worms, , Germany
Würzburg, , Germany
Würzburg, , Germany
Zwickau, , Germany
Countries
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Other Identifiers
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2007-000126-46
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ML20888
Identifier Type: -
Identifier Source: org_study_id
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