A Study of Monthly Subcutaneous (SC) Mircera for Maintenance Treatment of Participants With Chronic Kidney Disease on Peritoneal Dialysis
NCT ID: NCT00737477
Last Updated: 2017-06-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
96 participants
INTERVENTIONAL
2008-09-30
2011-07-31
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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Mircera in Renal Anemia
Participants will receive SC methoxy polyethylene glycol-epoetin beta (Mircera) 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 by the dose of ESA 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
Mircera will be administered SC every 4 weeks for a total of 48 weeks. The first dose of 120 or 200 mcg will be determined by the dose of ESA 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
Mircera will be administered SC every 4 weeks for a total of 48 weeks. The first dose of 120 or 200 mcg will be determined by the dose of ESA 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
* Chronic kidney disease-related anemia on peritoneal dialysis for ≥3 months
* Continuous SC maintenance stable ESA therapy for 4 weeks prior to study start
Exclusion Criteria
* Poorly controlled hypertension requiring interruption of ESA treatment in previous 6 months
* Significant acute or chronic bleeding during 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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Ch Notre Dame Misericorde; Hemodialyse
Ajaccio, , France
Centre Hospitalier; Hemodialyse
Annonay, , France
Ch D Arras; Nephrologie
Arras, , France
Ch D Auxerre; Nephrologie Hemodialyse
Auxerre, , France
CHU Saint Jacques; Centre De Dialyse
Besançon, , France
Ch Germon Et Gauthier; Hemodialyse
Beuvry, , France
Polyclin Bordeaux Nord Aquitaine; Nephrologie - Hemodialyse
Bordeaux, , France
Centre D Hemodialyse Saint Roch
Cabestany, , France
Hopital Clemenceau; Nephrologie Hemodialyse
Caen, , France
Hôpital Des Brousailles; Service de Néphrologie
Cannes, , France
CH William Morey; Nephrologie
Chalon-sur-Saône, , France
Ch De Chambery; Nephrologie
Chambéry, , France
Hopital Manchester; Nephrologie Hemodialyse
Charleville-Mézières, , France
Ch Hotel Dieu; Nephrologie
Chartres, , France
Ch Du Cotentin Site De Cherbourg; Nephrologie
Cherbourg Octeville, , France
Hopital Louis Pasteur; Nephrologie - Hemodialyse
Colmar, , France
Ch Laennec; Nephrologie Hemodialyse
Creil, , France
Hopital Du Bocage; Nephrologie
Dijon, , France
Ch De Dunkerque; Nephrologie
Dunkirk, , France
Chi Eure Seine D Evreux; Nephrologie
Évreux, , France
Agduc Muller
La Tronche, , France
Anider; Pharmacie
Le Petit-Quevilly, , France
Hopital Calmette; Medecine General & Nephrologie Serv.
Lille, , France
Ch Robert Bisson; Nephrologie
Lisieux, , France
Aural
Lyon, , France
Hopital Marc Jacquet; Nephrologie Hemodialyse
Melun, , France
Hopital Saint Andre; Nephrologie
Metz, , France
Echo Nantes Confluent; Uad Montfort
Nantes, , France
Ch Georges Renon; Nephrologie Hemodialyse
Niort, , France
Hopital de La Source; Service de Nephrologie & Hemodialyse
Orléans, , France
Unite Autodialyse Paris 14; Dialyse A Domicile
Paris, , France
Ch Pitie Salpetriere; Nephrologie Hemodialyse
Paris, , France
Hopital Bichat Claude Bernard; Nephrologie
Paris, , France
Hopital Tenon; Nephrologie Dialyse
Paris, , France
Chu La Miletrie;Nephrologie Transplantation
Poitiers, , France
Ch Rene Dubos; Dialyse Peritoneale
Pontoise, , France
Chi De Cornouaille; Nephrologie
Quimper, , France
Hopital De La Maison Blanche; Nephrologie Hemodialyse
Reims, , France
Ch De Bourran; Nephrologie Hemodialyse
Rodez, , France
Aurar; Aurar St Denis
Saint-Denis, , France
Memorial France Etats Unis; Nephrologie
Saint-Lô, , France
Hopital National; Nephrologie Hemodialyse
Saint-Maurice, , France
Aurar
Saint-Pierre, , France
HOPITAL NORD; NEPH Transplantation Reanimation
Saint-Priest-en-Jarez, , France
CH de Saintonge; Unite 1 Med Interne Nephrologie
Saintes, , France
Ch De Soissons; Medecine 5
Soissons, , France
Hopital Civil; Nephrologie Clinique Medicale B
Strasbourg, , France
Arauco; Arauco Tours Bretonneau
Tours, , France
Ch De Valence; Departement Medecine
Valence, , France
ALTIR
Vandœuvre-lès-Nancy, , France
CH Bretagne Atlantique de Vannes; Hemodialyse
Vannes, , France
Ch De Vittel; Nephrologie Hemodialyse
Vittel, , France
Countries
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Other Identifiers
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2008-001747-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ML21421
Identifier Type: -
Identifier Source: org_study_id
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