A Study of Subcutaneous Mircera for the Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease Not on Dialysis
NCT ID: NCT00642967
Last Updated: 2021-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
127 participants
INTERVENTIONAL
2008-06-30
2010-08-31
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 subcutaneous methoxy polyethylene glycol-epoetin beta every 4 weeks for a total of 48 weeks in this single-arm study. The first dose of 120 or 200 micrograms (mcg) will be determined based on the previous dose of epoetin or darbepoetin received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within the target range.
Methoxy Polyethylene Glycol-epoetin Beta
Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously every 4 weeks for a total of 48 weeks in this single-arm study. The first dose of 120 or 200 mcg will be determined based on the previous dose of epoetin or darbepoetin received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within the target range.
Interventions
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Methoxy Polyethylene Glycol-epoetin Beta
Methoxy polyethylene glycol-epoetin beta will be administered subcutaneously every 4 weeks for a total of 48 weeks in this single-arm study. The first dose of 120 or 200 mcg will be determined based on the previous dose of epoetin or darbepoetin received prior to administration of study treatment, while subsequent doses will be adjusted to maintain hemoglobin within the target range.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* continuous stable subcutaneous maintenance Erythropoietin-Stimulating Agent (ESA) therapy during previous month.
Exclusion Criteria
* significant acute or chronic bleeding;
* poorly controlled hypertension.
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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Aix-en-Provence, , France
Angers, , France
Angers, , France
Annonay, , France
Avignon, , France
Bastia, , France
Beauvais, , France
Besançon, , France
Bois-Guillaume, , France
Bordeaux, , France
Boulogne-sur-Mer, , France
Bourg-en-Bresse, , France
Bourges, , France
Brest, , France
Caen, , France
Chalon-sur-Saône, , France
Chartres, , France
Cherbourg Octeville, , France
Cholet, , France
Clermont-Ferrand, , France
Colmar, , France
Creil, , France
Créteil, , France
Dieppe, , France
Évreux, , France
Greize, , France
Harfleur, , France
La Garenne-Colombes, , France
La Tronche, , France
Le Havre, , France
Le Mans, , France
Lille, , France
Limoges, , France
Lyon, , France
Maubeuge, , France
Metz, , France
Metz-Tessy, , France
Montluçon, , France
Montpellier, , France
Montpellier, , France
Nancy, , France
Nice, , France
Nîmes, , France
Orléans, , France
Paris, , France
Paris, , France
Paris, , France
Paris, , France
Paris, , France
Pierre-Bénite, , France
Poitiers, , France
Quimper, , France
Roubaix, , France
Saint-Brieuc, , France
Saint-Laurent-du-Var, , France
Saint-Lô, , France
Saint-Michel, , France
Saint-Nazaire, , France
Salouël, , France
Sens, , France
St-Malo, , France
Strasbourg, , France
Suresnes, , France
Thionville, , France
Toulouse, , France
Tournan-en-Brie, , France
Valenciennes, , France
Vandœuvre-lès-Nancy, , France
Vannes, , France
Countries
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Other Identifiers
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2007-005757-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ML21146
Identifier Type: -
Identifier Source: org_study_id
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