| Outcome Measures: |
Primary: Change in Hemoglobin (Hb) Concentration Between the Baseline and the Evaluation Period for Each Patient, The Hb change from baseline was calculated on a per-participant basis using an individual's average for both the baseline and evaluation periods and taking the difference. The baseline period was defined as the time between the day of first study dose and the previous 35 days. The evaluation period was defined as the period between Week 17 and Week 21, inclusive., Baseline up to Week 21 | Secondary: Number of Participants With an Average Hb Concentration During the Evaluation Period Within ± 1 g/dL of Their Baseline Hb and Above, Within or Below the Range of 10-12 g/dL, Number of participants with an average Hb concentration during the evaluation period within ± 1 g/dL of their baseline Hb is reported as well as the number of participants with an average Hb concentration above, within or below the range of 10-12 g/dL. The evaluation period was defined as the period between Week 17 and Week 21 inclusive., Week 17 up to Week 21|Mean Hb Values and Change From Baseline, The mean Hb concentration over time and the mean change in Hb from baseline over time are presented., Baseline, Weeks 3, 5, 9, 13, 17, 19, 21, 25, 29, 33, 37, 41, 45|Change in Mircera Dose Over Time, A dose change was defined as a change in the administered dose strength compared to the preceding dose., Week 1 to Week 17|Ratio of Mircera Starting Dose (Week 1) to the Dose at Week 17, The ratio of Mircera dose was calculated as the median (min-max) ratio of starting dose (Week 1) to the dose at Week 17. Participants who withdrew before Week 17 or who were not administered a Mircera dose at Week 17 visit due to the applicable dose adjustment rules were excluded from the ratio computation., Week 1, Week 17|Number of Participants With Adverse Events by Severity as Assessed by Highest World Health Organization (WHO) Toxicity Grade, An adverse event is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product, any new disease, or exacerbation of existing disease (a worsening in the character, frequency, or severity of a known condition), recurrence of an intermittent medical condition or any deterioration in a laboratory value or other clinical test., Baseline up to Week 45|Bioavailability (F) of Mircera in Pediatric Participants Based on Population PK Model, Bioavailability (F) is defined as the percentage of the administered drug, that reaches the systemic circulation. A population PK model was developed for Mircera that adequately describes pediatric data: a 1-compartment model with first order absorption and elimination processes. The bioavailability (F) was estimated using all the data points listed under time frame using the population PK model., Pre-dose at Week 1, 9, 17; Post-dose at Week 3, Week 19 and additional sample taken between 24 hours and 5 days at participant's convenience
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| Locations: |
University of Alabama at Birmingham; Pediatric Nephrology, Birmingham, Alabama, 35233, United States|Loma Linda University health, Loma Linda, California, 92354, United States|Emory University School of Med; Pediatrics, Atlanta, Georgia, 30322, United States|Children'S Mercy Hospital; Pediatric Nephrology, Kansas City, Missouri, 64108, United States|RWJBarnabas Health, West Orange, New Jersey, 07052, United States|East Carolina University; Brody School of Medicine, Greenville, North Carolina, 27834, United States|UT Southwestern Medical Center; Pediatrics Dept., Dallas, Texas, 75390, United States|Hopital Jeanne De Flandre; Pediatrie, Lille, 59037, France|Gh Necker Enfants Malades; Nephrologie, Paris, 75743, France|Höpital Hautepierre; Pediatrie 1, Strasbourg, 67098, France|Semmelweis University; 1st Department of Pediatrics, Pediatric Nephrology Center, Budapest, 1083, Hungary|Debreceni Egyetem Klinikai Központ; Gyermekklinika, Debrecen, 4032, Hungary|Clinica Pediatrica II De Marchi, Milano, Lombardia, 20122, Italy|Ospedale Infantile Regina Margherita; U.O. Autonoma di Nefrologia, Dialisi e Trapianto, Torino, Piemonte, 10126, Italy|Vilnius University Children's Hospital, Vilnius, LT-08406, Lithuania|Uniwersyteckie Centrum Kliniczne; Klinika Chorob Nerek i Nadciśnienia Dzieci i Mlodziezy, Gdansk, 80-952, Poland|Uniwersytecki Szpital Dziecięcy w Krakowie; Oddz.Nefrologii i Nadciśnienia Tętniczego/Stacja Dializ, Kraków, 30-663, Poland|Instytut "Centrum Zdrowia Matki Polki; Klinika Pediatrii i Immunologii i Nefrologii, Lodz, 93-338, Poland|Szpital Specjalistyczny dla Dzieci i Doroslych; Oddzial Kliniczny Pediatrii i Nefrologii, Torun, 87-100, Poland|Szpital Kliniczny nr 1 im. prof. Szyszko; Oddz. Nefrologii Dzieciecej z Pododdziałem Dializoterapii, Zabrze, 41-800, Poland|Hospital Universitari Vall d'Hebron; Servicio de Nefrologia, Barcelona, 08035, Spain|Hospital Universitario Virgen del Rocio; Servicio de Nefrologia Pediatrica, Sevilla, 41013, Spain
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