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Clinical Trial Details

Trial ID: L1612
Source ID: NCT00717821
Associated Drug: Methoxy Polyethylene Glycol-Epoetin Beta
Title: A Study of Once Monthly Intravenous or Subcutaneous Mircera in Participants With Chronic Kidney Disease on Hemodialysis.
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Anemia
Interventions: DRUG: Methoxy Polyethylene Glycol-epoetin Beta|DRUG: Epoetin Beta|DRUG: Darbepoetin Alfa
Outcome Measures: Primary: Percentage of patients maintaining average Hb concentration within target range (10-12g/dL) during evaluation period., Weeks 16-24 | Secondary: Mean change in Hb concentration between reference and evaluation period, and mean time spent in Hb range of 10-12g/dL during evaluation period., Weeks 16-24|Dose adjustments, RBC transfusions, AEs., Throughout study
Sponsor/Collaborators: Sponsor: Hoffmann-La Roche
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 421
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2008-08
Completion Date: 2011-07
Results First Posted:
Last Update Posted: 2021-09-14
Locations: Abbeville, 80103, France|Albi, 81030, France|Amilly, 45200, France|Angers, 49933, France|Annonay, 07103, France|Antony, 92166, France|Aubagne, 13400, France|Aulnay Sous Bois, 93604, France|Avignon, 84902, France|Bagnols Sur Ceze, 30200, France|Beauvais, 60021, France|Besancon, 25030, France|Beuvry, 62660, France|Beziers, 34525, France|Bois Bernard, 62320, France|Bordeaux, 33077, France|Brest, 29200, France|Cabestany, 66330, France|Caen, 14033, France|Cannes, 06401, France|Carpentras, 84200, France|Castelnau le Lez, 34170, France|Chamalieres, 63400, France|Charleville Mezieres, 08011, France|Clermont-ferrand, 63003, France|Colmar, 68024, France|Compiegne, 60200, France|Creil, 60109, France|Creteil, 94010, France|Dijon, 21000, France|Draguignan, 83300, France|Evry, 91035, France|Fleury Merogis, 91700, France|Hyeres, 83400, France|La Chaussee St Victor, 41260, France|La Rochelle, 17019, France|La Tronche, 38701, France|Le Mans, 72037, France|Le Petit Quevilly, 76143, France|Le Port Marly, 78560, France|Lille, 59037, France|Lille, 59042, France|Lliie, 59003, France|Lyon, 69008, France|Manosque, 04100, France|Marseille, 13008, France|Marseille, 13253, France|Meaux, 77104, France|Metz, 57003, France|Montpellier, 34295, France|Mulhouse, 68070, France|Muret, 31600, France|Nantes, 44035, France|Orleans, 45000, France|Paris, 75 016, France|Paris, 75008, France|Paris, 75013, France|Paris, 75015, France|Paris, 75651, France|Paris, 75674, France|Paris, 75970, France|Perpignan, 66046, France|Pessac, 33608, France|Pierre Benite, 69495, France|Poissy, 78303, France|Poitiers, 86021, France|Quincy Sous Senart, 91480, France|Reims, 51092, France|Rouen, 76040, France|Rueil Malmaison, 92500, France|Saint Ouen, 93400, France|Saintes, 17108, France|St Benoit, 97470, France|St Brieuc, 22027, France|St Denis, 97405, France|St Maurice, 94415, France|St Ouen, 93400, France|St Pierre, 97448, France|St Priest En Jarez, 42277, France|St Quentin, 02100, France|Strasbourg, 67200, France|Tassin, 69150, France|Toulon, 83056, France|Toulouse, 31059, France|Toulouse, 31077, France|Trappes, 78190, France|Vandoeuvre-les-nancy, 54511, France|Vannes, 56017, France|Vienne, 38209, France|Villeurbanne, 69626, France
URL: https://clinicaltrials.gov/show/NCT00717821