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Clinical Trial Details

Trial ID: L1679
Source ID: NCT00642967
Associated Drug: Methoxy Polyethylene Glycol-Epoetin Beta
Title: A Study of Subcutaneous Mircera for the Maintenance Treatment of Anemia in Participants With Chronic Kidney Disease Not on Dialysis
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Anemia
Interventions: DRUG: Methoxy Polyethylene Glycol-epoetin Beta
Outcome Measures: Primary: Proportion of patients maintaining average Hb concentration within target range of 10-12g/dL during evaluation period, Weeks 16-24 | Secondary: Mean change in Hb concentration, Between reference and Efficacy Evaluation Period|Mean time spent in Hb range, Weeks 16-24|% patients maintaining Hb concentration within target range; % patients requiring dose adjustments; incidence of RBC transfusions, Weeks 16-48|AEs, lab parameters, Throughout study
Sponsor/Collaborators: Sponsor: Hoffmann-La Roche
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 127
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2008-06
Completion Date: 2010-08
Results First Posted:
Last Update Posted: 2021-09-14
Locations: Aix En Provence, 13090, France|Angers, 49000, France|Angers, 49933, France|Annonay, 07103, France|Avignon, 84902, France|Bastia, 20604, France|Beauvais, 60000, France|Besancon, 25030, France|Bois-guillaume, 76233, France|Bordeaux, 33077, France|Boulogne Sur Mer, 62321, France|Bourg En Bresse, 01012, France|Bourges, 18020, France|Brest, 29609, France|Caen, 14033, France|Chalon Sur Saone, 71100, France|Chartres, 28000, France|Cherbourg Octeville, 50102, France|Cholet, 49300, France|Clermont-ferrand, 63058, France|Colmar, 68024, France|Creil, 60100, France|Creteil, 94010, France|Dieppe, 76202, France|Evreux, 27023, France|Greize, 69400, France|Harfleur, 76700, France|La Garenne-colombes, 92250, France|La Tronche, 38701, France|Le Havre, 76083, France|Le Mans, 72037, France|Lille, 59042, France|Limoges, 87042, France|Lyon, 69437, France|Maubeuge, 59604, France|Metz Tessy, 74370, France|Metz, 57045, France|Montlucon, 03108, France|Montpellier, 34097, France|Montpellier, 34295, France|Nancy, 54100, France|Nice, 06002, France|Nimes, 30006, France|Orleans, 45000, France|Paris, 75018, France|Paris, 75651, France|Paris, 75743, France|Paris, 75908, France|Paris, 75970, France|Pierre Benite, 69495, France|Poitiers, 86021, France|Quimper, 29000, France|Roubaix, 59056, France|Saint Laurent Du Var, 06721, France|Saint Lo, 50009, France|Saint-malo, 35043, France|Saint-michel, 16470, France|Salouel, 80480, France|Sens, 89108, France|St Brieuc, 22027, France|St Nazaire, 44606, France|Strasbourg, 67091, France|Suresnes, 92151, France|Thionville, 57126, France|Toulouse, 31059, France|Tournan-en-brie, 77220, France|Valenciennes, 59300, France|Vandoeuvre-les-nancy, 54511, France|Vannes, 56017, France
URL: https://clinicaltrials.gov/show/NCT00642967

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress