| Outcome Measures: |
Primary: Change in Average Hb Concentration Between Baseline and Evaluation Period, A time adjusted average baseline Hb concentration for each individual was calculated using an area under the curve (AUC) approach from all available Hb measurements taken during the baseline period (Day -20 to Day 1). The average evaluation period Hb concentration for each individual was calculated using the same method, from all their available measurements taken during the evaluation period (Week 17 to Week 21). The change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the baseline Hb concentration from the evaluation period Hb concentration., Baseline (Day -20 to Day 1), Evaluation Period (Week 17 to Week 21) | Secondary: Number of Participants With an Average Hb Concentration During the Evaluation Period Within ±1 g/dL of Their Baseline Hb, Baseline Hb value was defined as the average Hb concentration from all available Hb measurements taken during the baseline period (Day -20 to Day 1). The evaluation period Hb concentration was defined as the average Hb concentration from all available Hb measurements taken during the evaluation period (Week 17 to Week 21)., Evaluation Period (Week 17 to Week 21)|Number of Participants With an Average Hb Concentration During the Evaluation Period Above, Within or Below the Range of 10-12 g/dL, The evaluation period Hb concentration was defined as the average Hb concentration from all available Hb measurements taken during the evaluation period (Week 17 to Week 21)., Evaluation Period (Week 17 to Week 21)|Number of Participants With Blood Transfusions, Baseline to Week 20|Change in Average Reticulocyte Count Between the Baseline and Evaluation Period, A time adjusted average baseline reticulocyte count for each individual was calculated using an AUC approach from all available reticulocyte counts taken during the baseline period (Day -20 to Day 1). The average evaluation period reticulocyte count for each individual was calculated using the same method, from all their available measurements taken during the evaluation period (Weeks 17 to 21). The change in reticulocyte count between the baseline and evaluation periods was calculated by subtracting the baseline reticulocyte count from the evaluation period reticulocyte count. Relative reticulocytes were recorded conversion to absolute values was performed., Baseline (Day -20 to Day 1), Evaluation Period (Week 17 to Week 21)|Maximum Observed Serum Concentration (Cmax) of MIRCERA, Cmax was defined as the highest serum concentration observed from all sample collection timepoints (as provided in timeframe) and was averaged out among participants and reported., Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13|Area Under the Serum Concentration-Time Curve From 0 to 672 Hours (AUC0-672h) of MIRCERA, Area under the serum concentration versus time curve over 672 hours. AUC0-672h represents area under the serum concentration versus time curve from time zero to end of dosing interval (AUC0-tau)., Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13|Time to Reach Cmax (Tmax) of MIRCERA, Tmax was defined as the time (in hours) to achieve Cmax (Cmax was defined as the highest serum concentration observed over all sample collection timepoints \[as provided in timeframe\]). The median time, among all participants, was reported., Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13|Apparent Terminal Phase Half-Life (t1/2) of MIRCERA, t1/2 was defined as the time (in hours) measured (from all sample collection timepoints \[as provided in timeframe\]) for the serum concentration to decrease by one half. The t1/2 was calculated as natural logarithm of 2 divided by λz; where λz = terminal elimination rate constant., Pre-dose (with 1 hour before drug administration) and 2, 48 hours post dose on Week 9, at Weeks 10, 11, and 12, pre-dose (with 1 hour before drug administration) on Week 13
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| Locations: |
Royal Children'S Hospital; Department of Nephrology, Parkville, Victoria, 3052, Australia|Hôpital Enfants Reine Fabiola, Bruxelles, 1020, Belgium|UZ Leuven Gasthuisberg, Leuven, 3000, Belgium|Hopital Femme Mere Enfant; Ped Nephrologie Rhumatologie, Bron, 69677, France|Hopital Jeanne De Flandre; Cons Pediatrie, Lille, 59037, France|Hopital Timone Enfants; Nephrologie Hemodialyse, Marseille, 13385, France|Hopital Arnaud De Villeneuve; Pediatrie I, Montpellier, 34295, France|Hôpital Robert Debré; Nephrologie pediatrique, Paris, 75019, France|Hopital Armand Trousseau; Pediatrie Nephrologie, Paris, 75571, France|Höpital Hautepierre; Pediatrie 1, Strasbourg, 67098, France|KfH Nierenzentrum für Kinder und Jugendliche, Hamburg, 20246, Germany|KfH-Nierenzentrum fur Kinder und Jugendliche, Heidelberg, 69120, Germany|Klinik der Uni zu Köln; Kinderklinik, Köln, 50937, Germany|Kinderklinik Memmingen; Kinderdialysezentrum, Memmingen, 87700, Germany|KfH-Nierenzentrum für Kinder und Jugendliche, Münster, 48149, Germany|Semmelweis University; 1st Department of Pediatrics, Pediatric Nephrology Center, Budapest, 1083, Hungary|Ospedale Pediatrico Bambino Gesu; U.O. Di Nefrologia E Dialisi, Roma, Lazio, 00165, Italy|IRCCS G. Gaslini; U.O. Nefrologia, Dialisi e Trapianto, Genova, Liguria, 16148, Italy|Ospedale Infantile Regina Margherita; U.O. Autonoma di Nefrologia, Dialisi e Trapianto, Torino, Piemonte, 10126, Italy|A.O. Di Padova; Dipartimento Di Pediatria U.O. Di Nefrologia Pediatrica, Dialisi e Trapianto, Padova, Veneto, 35128, Italy|Uniwersyteckie Centrum Kliniczne; Klinika Chorob Nerek i Nadciśnienia Dzieci i Mlodziezy, Gdansk, 80-294, Poland|Instytut "Centrum Zdrowia Matki Polki; Klinika Nefrologii i Dializoterapii, Lodz, 93-338, Poland|Dzieciecy Szpital Kliniczny; Klinika Nefrologii Dzieciecej, Lublin, 20-093, Poland|SPSZOZ Zdroje Oddzial Pediatrii; Nefrologii i Toksykologii ze Stacja Dializ, Szczecin, 70-410, Poland|Wojewodzki Szpital Dzieciecy; Osrodek Chorob Nerek i Dializoterapii, Torun, 87-100, Poland|Instytut Pomnik-Centrum Zdrowia Dziecka, Klinika Nefrologii, Transp. Nerek i Nadcisnienia Tetniczego, Warszawa, 04-730, Poland|Akademia Medyczna im. Piastow Slaskich; Katedra i Klinika Nefrologii Pediatrycznej, Wroclaw, 50-369, Poland|Fundeni Clinical Institute, Bucharest, 022328, Romania|St. Maria Emergency Clinical Hospital for Children, Iasi, 700309, Romania|DGCB St. Vladimir; Pediatric nephrologist, Moscow, 107014, Russian Federation|SBIH Children City Hospital #1; Dialysis department, Saint-Petersburg, 198205, Russian Federation|Hospital Universitari Vall d'Hebron; Servicio de Nefrologia, Barcelona, 08035, Spain|Hospital Universitario La Paz: Nefrologia Pediatrica, Madrid, 28046, Spain|Hospital Universitario Virgen del Rocio; Servicio de Nefrologia Pediatrica, Sevilla, 41013, Spain|Hospital Universitario la Fe; Servicio de Nefrologia Pediatrica, Valencia, 46009, Spain|Chulalongkorn university Faculty of Medicine;Department of Pediatrics, Bangkok, 10310, Thailand|Siriraj Hospital, Faculty of Medicine; Department of Pediatrics, Bangkok, 10700, Thailand|Kiev city childrens nephrological center of hospital #1; Nephrology and RRT, Kiev, 04209, Ukraine|Public Institution Zaporizhzhia City Multispecialty Children's Hospital #5; Allergologic, Zaporizhzhia, 69076, Ukraine
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