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Clinical Trial Details

Trial ID: L1752
Source ID: NCT05682326
Associated Drug: Daprodustat
Title: Anemia Studies in CKD: Erythropoiesis Via a Novel PHI Daprodustat - Pediatric (ASCEND-P)
Acronym: ASCEND-P
Status: COMPLETED
Study Results: NO
Results:
Conditions: Anaemia
Interventions: DRUG: Daprodustat
Outcome Measures: Primary: Number of participants with adverse events (AEs) and serious adverse events (SAEs), All AEs and SAEs will be collected., Up to 56 weeks|Number of participants with adverse event of special interests (AESIs), All AESI will be collected., Up to 56 weeks|Number of participants with AEs leading to study intervention discontinuation, All AEs leading to study intervention discontinuation will be collected., Up to 52 weeks | Secondary: Number of participants with change from baseline in laboratory safety parameters, Number of participants with abnormal laboratory safety parameters will be assessed., Baseline (Day 1) and up to Week 56|Mean change from baseline in blood pressure (BP), Blood pressure readings in millimeters of mercury (mmHg) will be collected., Baseline (Day 1) and up to Week 56|Mean change from baseline in heart rate (HR), Heart rate readings in beats per minutes (bpm) will be collected., Baseline (Day 1) and up to Week 56|Mean change from baseline in weight, Weight readings in kilogram (kg) will be collected., Baseline (Day 1) and up to Week 56|Mean change from baseline in height, Height readings in centimeters (cm) will be collected., Baseline (Day 1) and up to Week 56|Mean Hgb value, Blood samples will be collected from all participants for measurement of Hgb (grams per deciliter \[g/dL\]) values., Up to Week 56|Mean change from baseline in Hgb values, Blood samples will be collected from all participants for measurement of Hgb (g/dL) values., Baseline (Day 1) and up to Week 56|Number of participants with Hgb values above, below and within the target range (10 to 12 g/dL), Number of participants with Hgb values above, below, and within the target range (10 to 12g/dL) will be assessed., Up to week 56|Mean daprodustat dose, Mean values of daprodustat will be calculated and reported., Up to Week 56|Number of participants with 0 to 10, or greater than [>] 10 dose adjustments, Number of participants with 0 to 10, or \>10 dose adjustments form the starting dose of dapurodustat will be assessed., Up to Week 56|Number of participants assigned to each dose level at each visit, Number of participants assigned to each dose level of dapurodustat will be assessed, Up to Week 56|Maximum plasma concentration (Cmax) of daprodustat and its metabolites, Blood samples will be collected for the plasma concentrations of daprodustat from which PK parameters will be determined., Up to Week 4|Area under the curve (AUC) at steady state of daprodustat and its metabolites, Blood samples will be collected for the plasma concentrations of daprodustat from which PK parameters will be determined., Up to Week 4|Plasma concentrations of daprodustat metabolites at pre-dose trough (Ctrough), Blood samples will be collected for the plasma concentrations of daprodustat metabolites from which PK parameters will be determined., Up to Week 4
Sponsor/Collaborators: Sponsor: GlaxoSmithKline
Gender: ALL
Age: CHILD
Phases: PHASE3
Enrollment: 4
Study Type: INTERVENTIONAL
Study Designs: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-09-06
Completion Date: 2025-03-17
Results First Posted:
Last Update Posted: 2025-04-22
Locations: GSK Investigational Site, Aichi, 466-8650, Japan|GSK Investigational Site, Saitama, 330-8777, Japan|GSK Investigational Site, Tokyo, 162-8666, Japan|GSK Investigational Site, Yangsan, 50612, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT05682326