| Outcome Measures: |
Primary: Percentage of Participants With Lesser Than or Equal to One Gram Per Deciliter Decrease in Average Hemoglobin From Baseline and Maintaining Average Hemoglobin Level Greater Than or Equal to 10.5 g/dL Over Evaluation Period, Randomized participants with an average hemoglobin (Hb) decrease from Baseline (Week -4 to Week -1) not exceeding 1.0 gram per deciliter (g/dL) and an absolute average Hb \>= 10.5 g/dL during the evaluation period (Weeks 50-53) were defined as responders. Non-responders included participants without any Hb data during the second treatment period and those who did not meet the response criteria and thus were not included in the analysis., Baseline (Week -4 to Week -1) and Evaluation period (Weeks 50 to 53) | Secondary: Mean Percentage Change in MIRCERA and Darbepoetin Alpha Dose Over Time, All participants received once monthly treatment schedule of both MIRCERA and darbepoetin alpha for the respective treatment arms after Week 27 and these analyses are based on the absolute doses. The average dose in Months 11 and 12 was defined as the mean of all administered doses between study Days 302 and 363. The change in dose was calculated as the percentage change between the respective dose at Week 27 and the average corresponding dose during Months 11 and 12 in each treatment group., Week 27 to Month 12|Number of Participants With Marked Laboratory Abnormality Over Time, Values of laboratory parameters higher (H) or lower (L) than the Roche defined reference range were considered as abnormality. The laboratory parameters with abnormality were platelets, white blood cells (WBC), albumin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), and potassium. Blood samples were drawn before drug administration and before the dialysis session., Up to Week 53|Median Blood Pressure Over Time, Systolic and diastolic blood pressures (BP) were measured before and after the dialysis session at every week from Baseline (Week -4 to Week -1) to Week 53. Median pre-dialysis diastolic blood pressure (PrD DBP) , median post-dialysis diastolic blood pressure (PoD DBP), median pre-dialysis systolic blood pressure (PrD SBP), and post-dialysis systolic blood pressure (PoD SBP) were reported at Baseline (Week -4 to Week -1) , Week 28 and Week 52., Baseline (Week -4 to Week -1), Week 28, and Week 52|Mean Pulse Rate Over Time, Pulse rate is defined as the number of heartbeats in a minute and was assessed in sitting position of the participants at every week from Baseline (Week -4 to Week -1) to Week 53. Summary data of mean values of pulse rate are presented at Baseline (Week -4 to Week -1), Week 28 and Week 52., Baseline (Week -4 to Week -1), Week 28, and Week 52|Number of Participants With Any Adverse Events, Serious Adverse Events, and Deaths, An adverse event (AE) can be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. A serious adverse event (SAE) is any adverse event that can result in death or is life-threatening or required in participants hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity; or is a congenital anomaly/birth defect; or is medically significant or requires intervention to prevent one or other of the outcomes listed above. SAEs were reported up to Week 56, while nonserious AEs up to Week 52., From screening to Week 56
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| Locations: |
Adelaide, SA 5000, Australia|Clayton, 3186, Australia|Gosford, 2250, Australia|Parkville, 3052, Australia|Woolloongabba, 4102, Australia|Linz, 4010, Austria|Wien, 1090, Austria|Wien, 1220, Austria|Aalst, 9300, Belgium|Bruxelles, 1020, Belgium|Bruxelles, 1200, Belgium|Roeselare, 8800, Belgium|Calgary, Alberta, T2N 2T9, Canada|Hamilton, Ontario, L8N 4A6, Canada|Kitchener, Ontario, N2G 1N9, Canada|Mississauga, Ontario, L5M 2V8, Canada|Ottawa, Ontario, K1H 7W9, Canada|Toronto, Ontario, M5G 2C4, Canada|Greenfield Park, Quebec, J4V 2H1, Canada|Trois-rivieres, Quebec, G8Z 4K8, Canada|Aalborg, 9100, Denmark|Hillerød, 3400, Denmark|Roskilde, 4000, Denmark|Tampere, 33521, Finland|Turku, 20521, Finland|Auch, 32000, France|Bordeaux, 33000, France|Boulogne, 62321, France|Castelnau Le Lez, 34170, France|Cergy Pontoise, 95303, France|Chamalieres, 63400, France|Dijon, 21079, France|Fleury-merogis, 91712, France|Herouville Saint Clair, 14202, France|La Tronche, 38701, France|Lyon, 69437, France|Montpellier, 34295, France|Nimes, 30029, France|Paris, 75015, France|Paris, 75970, France|Reims, 51092, France|Rennes, 35033, France|Saint Herblain, 44093, France|Saint Ouen, 93400, France|St Brieuc, 22027, France|Villeurbanne, 69100, France|Bad Hersfeld, 36251, Germany|Bonn, 53127, Germany|Dortmund, 44263, Germany|München, 80804, Germany|Stuttgart, 70191, Germany|Villingen-schwenningen, 78054, Germany|Bologna, 40138, Italy|Como, 22100, Italy|Genova, 16132, Italy|Lecco, 23900, Italy|Modena, 41100, Italy|Pavia, 27100, Italy|Prato, 50047, Italy|Venezia, 30122, Italy|Amsterdam, 1081 HV, Netherlands|Dordrecht, 3318 AT, Netherlands|Leiria, 2400-441, Portugal|Alicante, 03010, Spain|Badalona, 08915, Spain|Barcelona, 08003, Spain|Barcelona, 08036, Spain|Bilbao, 48013, Spain|Córdoba, 14004, Spain|Leon, 24071, Spain|Madrid, 28003, Spain|Madrid, 28035, Spain|Madrid, 28040, Spain|Madrid, 28041, Spain|Madrid, 28046, Spain|Madrid, 28222, Spain|Orense, 32005, Spain|Santander, 39008, Spain|Vigo, 36204, Spain|Vigo, 36205, Spain|Aarau, 5001, Switzerland|Lausanne, 1003, Switzerland|Belfast, BT9 7LJ, United Kingdom|Canterbury, CT1 3NE, United Kingdom|Glasgow, G4 OSF, United Kingdom|London, SE22 8PT, United Kingdom|Manchester, M13 9WL, United Kingdom|Truro, TR1 3LJ, United Kingdom
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