| Outcome Measures: |
Primary: Change from baseline in Hb level to the average Hb level over treatment weeks 20 to 24, Mean change in Hb level between baseline and average Hb level over treatment weeks 20 to 24., Baseline and weeks 20 to 24 | Secondary: Pharmacokinetics (PK) of roxadustat in plasma: Maximum concentration (Cmax), Cmax will be recorded from the PK plasma samples collected., Up to week 8|PK of roxadustat in plasma: Area under the plasma-concentration time curve (AUC), AUC will be recorded from the PK plasma samples collected., Up to week 8|PK of roxadustat in plasma: Apparent total clearance (CL/F), CL/F will be recorded from the PK plasma samples collected., Up to week 8|PK of roxadustat in plasma: Time of the maximum concentration (Tmax), Tmax will be recorded from the PK plasma samples collected., Up to week 8|Hb levels at all timepoints, Hb levels at all timepoints will be recorded., Up to week 56|Dose titration history at all timepoints, Dose titration history at all timepoints will be recorded., Up to week 52|Number of participants with treatment-emergent adverse events (TEAEs), An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of roxadustat, whether or not considered related to roxadustat. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of roxadustat. This includes events related to the comparator and events related to the (study) procedures. A TEAE is defined as an AE observed after starting administration of roxadustat through 28 days after the last dose of roxadustat., From first dose of study drug and up to week 56|Number of participants with treatment-emergent cardiovascular AEs, Treatment-emergent cardiovascular AEs will be recorded., From first dose of study drug and up to week 56|Number of participants with treatment-emergent thrombotic AEs, Treatment-emergent thrombotic AEs will be recorded., From first dose of study drug and up to week 56|Number of participants with laboratory value abnormalities and/or AEs, Number of participants with potentially clinically significant laboratory values., Up to week 52|Number of participants with vital sign abnormalities and/or AEs, Number of participants with potentially clinically significant vital sign values., Up to week 52|Change from baseline in growth parameter value: Height, Height will be recorded at all timepoints., Baseline and up to week 52|Change from baseline in growth parameter value: Weight, Weight will be recorded at all timepoints., Baseline and up to week 52|Number of participants with physical examinations abnormalities and/or AEs, Number of participants with potentially clinically significant physical examination abnormalities., Up to week 52|Percentage of participants with Hb response, For ESA-treated participants, response is defined as a participant achieving 2 consecutive Hb values within 1 g/dL of baseline or the target range of 10.0 to 12.0 g/dL at the end of the 24-week treatment evaluation period (i.e., weeks 20 to 24) without having received rescue therapy within 6 weeks prior to or during this 4-week evaluation period. For ESA-naïve participants, response is defined as a participant achieving 2 consecutive Hb values within the target range of 10.0 to 12.0 g/dL at the end of the 24-week treatment evaluation period (i.e., weeks 20 to 24) without having received rescue therapy within 6 weeks prior to or during this 4-week evaluation period, Up to Week 24|Mean monthly intravenous (IV) iron use, Summaries of monthly IV iron usage (number of administrations) will be recorded., Up to week 52|Mean Monthly total IV iron dosage, Summaries of monthly IV iron usage (total dosage) will be recorded., Up to week 52|Percentage of participants using IV iron, Percentage of participants using IV iron by study period will be recorded., Up to week 52|Percentage of participants using oral iron, Percentage of participants using oral iron by study period will be recorded., Up to week 52|Percentage of participants using rescue therapy, Percentage of participants using rescue therapy by study period will be recorded., Up to week 52|Palatability questionnaire, The palatability questionnaire will assess taste and ability to swallow the medication using a 5 point Likert scale: for taste from 0 (Really bad) to 4 (Really good); for ability to swallow from 0 (Really Difficult) to 4 (Really Easy). The number of participants recorded for each response category will be provided., Up to week 52|Change from baseline in Pediatric Quality of Life (PedsQL) Inventory Score, PedsQL Inventory Scale comprises of 23 items (except for ages 2-4 which has only 21 items, 3 of which are only answered if the child attends school or daycare) in 4 domains: physical functioning, emotional functioning, social functioning and school functioning. A Likert scale from 0 (Never) to 4 (Almost always) will be used to record response. Higher scores indicate better quality of life., Baseline and up to week 52|Change from baseline in PedsQL Multidimensional Fatigue Scale questionnaire QoL Score, PedsQL Multidimensional Fatigue Scale comprises of 18 items in 3 domains: general fatigue, sleep/rest fatigue and cognitive fatigue. A Likert scale from 0 (Never) to 4 (Almost always) will be used to record response. Higher scores indicate better quality of life., Baseline and up to week 52
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| Locations: |
Site BE32002, Brussels, Belgium|Site BE32001, Edegem, Belgium|Site BE32004, Gent, Belgium|Site BE32003, Leuven, Belgium|Site BG35901, Sofia, Bulgaria|Site HR38501, Zagreb, Croatia|Site HR38503, Zagreb, Croatia|Site CZ42002, Brno, Czechia|Site CZ42001, Prague, Czechia|Site DK45001, Aarhus, 8200, Denmark|Site DE49001, Tubingen, Germany|Site GR30002, Athens, Greece|Site GR30001, Thessaloniki, Greece|Site IE35301, Dublin, Ireland|Site IT39003, Milano, Italy|Site LB96101, Achrafieh, Lebanon|Site LT37001, Vilnius, Lithuania|Site NL31002, Rotterdam, Netherlands|Site NO47002, Oslo, Norway|Site RO40002, Clug Napoca, 400370, Romania|Site RO40001, Timisoara, 30011, Romania|Site SA96602, Dammam, Saudi Arabia|Site SA96601, Riyadh, Saudi Arabia|Site SK42101, Bratislava, Slovakia|Site SP34001, Madrid, 28041, Spain|Site SE46002, Molnlycke, Sweden|Site SE46003, Mölnlycke, Sweden|Site TR90001, Ankara, Turkey|Site TR90010, Ankara, Turkey|Site TR90008, Istanbul, Turkey|TR90003, Istanbul, Turkey|Site TR90005, Izmit, Turkey|Site TR90006, Kayseri, Turkey|Site TR90002, Manisa, Turkey|Site GB44005, Cardiff, United Kingdom|Site GB44006, Glasgow, United Kingdom|Site GB44008, Liverpool, United Kingdom|Site GB44007, London, United Kingdom|Site GB44003, Newcastle Upon Tyne, United Kingdom|Site GB44001, Nottingham, United Kingdom|Site GB44004, Southampton, United Kingdom
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