A trial of daprodustat to treat anemia in children and young people aged 3 months to <18 years with chronic kidney disease.

An Integrated Pharmacokinetic and Safety Open-label Basket Trial of Daprodustat for the Treatment of Anemia Associated with Chronic Kidney Disease in Male and Female Children and Adolescents Aged 3 Months to Under 18 Years Requiring or Not Requiring Dialysis. - ASCEND-P

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-002013-34-ES

Enrollment

120

Registered

2022-09-19

Start date

2023-03-27

Completion date

Unknown

Last updated

2023-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia associated with chronic kidney disease (CKD) MedDRA version: 23.1 Level: PT Classification code 10064848 Term: Chronic kidney disease System Organ Class: 10038359 - Renal and urinary disorders

Interventions

Product Name: Daprodustat Product Code: GSK1278863 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: DAPRODUSTAT CAS Number: 960539-70-2 Current Sponsor code: GSK1278863A (A denotes the fre

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Participant must be 3 months to =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Kidney transplant recipient with a functioning allograft. 2. Scheduled for elective kidney transplantation within 3 months. 3. Iron deficiency, defined as: - Transferrin saturation (TSAT) 480 msec, or • QT interval corrected for heart rate (QTc) >500 msec in participants with bundle branch block. 14. Liver abnormality/disease as described in the protocol. 15. Participants who have previously received treatment with any HIF-PHI, including daprodustat within the last 30 days. 16. Participants who have previously failed to respond to treatment with daprodustat or any other HIF-PHI. 17. Participants, who have received within the last 7 days, or anticipate receiving during the study, strong inhibitors of CYP2C8 (e.g., gemfibrozil) or strong inducers of CYP2C8 (e.g., rifampin/rifampicin). 18. Other investigational product/clinical study: Participants who have received treatment with an investigational agent (biologic or non-biologic) within the past 30 days or 5 drug half-lives whichever is longer, with the exception of treatments or vaccines for SARS-CoV-2 with provisional or emergency approval. 19. Participants who are currently participating in any other clinical study of an investigational medicinal product (IMP). 20. Participants with any history of hypersensitivity to daprodustat or its excipients, or to any other HIF-PHI.

Design outcomes

Primary

Measure	Time frame
Main Objective: Primary (Safety): Describe the safety of daprodustat, overall (all ages) and in each age group;Secondary Objective: Secondary Safety: Describe changes in other parameters relevant to safety, overall and in each age group. Secondary Efficacy: - Describe the effect of daprodustat on Hgb, overall and in each age group (and additionally overall in all ages by ESA use [yes/no] at study enrollment). - Describe the change in required dose over time, in each age group. Secondary Pharmacokinetic: - Characterize the PK of daprodustat in each age group. - Describe the systemic exposure to daprodustat metabolites, M2, M3, M4, M5, M6 and M13 in each age group.;Primary end point(s): Primary (Safety): Incidence of AEs, Serious Adverse Events (SAEs), AESIs, and AEs leading to study intervention discontinuation.;Timepoint(s) of evaluation of this end point: AE/SAE assessment: From Screening (-4 weeks to Day 1) to Follow-up (week 56)	—

Measure

Time frame

Main Objective: Primary (Safety): Describe the safety of daprodustat, overall (all ages) and in each age group;Secondary Objective: Secondary Safety: Describe changes in other parameters relevant to safety, overall and in each age group. Secondary Efficacy: - Describe the effect of daprodustat on Hgb, overall and in each age group (and additionally overall in all ages by ESA use [yes/no] at study enrollment). - Describe the change in required dose over time, in each age group. Secondary Pharmacokinetic: - Characterize the PK of daprodustat in each age group. - Describe the systemic exposure to daprodustat metabolites, M2, M3, M4, M5, M6 and M13 in each age group.;Primary end point(s): Primary (Safety): Incidence of AEs, Serious Adverse Events (SAEs), AESIs, and AEs leading to study intervention discontinuation.;Timepoint(s) of evaluation of this end point: AE/SAE assessment: From Screening (-4 weeks to Day 1) to Follow-up (week 56)

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Secondary

Measure	Time frame
Secondary end point(s): Secondary Safety: Changes from baseline in laboratory safety parameters, blood pressure (BP), heart rate (HR), height and weight at each time point. Secondary Efficacy: At each study time point: • Hgb value. • Hgb change from baseline. • Hgb above, below and within the target range (10 to 12 g/dL). At each study time point: • Daprodustat dose. • Daprodustat dose change from starting dose. During the course of the study: • Number of dose changes. Secondary Pharmacokinetic: • PK parameters: maximum plasma concentration (Cmax) and area under the curve (AUC) at steady state. • Plasma concentrations of each daprodustat metabolite at pre-dose (trough) between Week 2 to Week 4, and corresponding Cmax if data permit.;Timepoint(s) of evaluation of this end point: Vital signs (BP, HR), Height, weight: From Screening (-4 weeks to Day 1) to Follow-up (week 56) Hgb (full blood count): From Screening (-4 weeks to Day 1) to Follow-up (week 56) PK Sampling (Optional unless in the Integrated PK Phase): Day 1, Week 2, Week 4	—

Measure

Time frame

Secondary end point(s): Secondary Safety: Changes from baseline in laboratory safety parameters, blood pressure (BP), heart rate (HR), height and weight at each time point. Secondary Efficacy: At each study time point: • Hgb value. • Hgb change from baseline. • Hgb above, below and within the target range (10 to 12 g/dL). At each study time point: • Daprodustat dose. • Daprodustat dose change from starting dose. During the course of the study: • Number of dose changes. Secondary Pharmacokinetic: • PK parameters: maximum plasma concentration (Cmax) and area under the curve (AUC) at steady state. • Plasma concentrations of each daprodustat metabolite at pre-dose (trough) between Week 2 to Week 4, and corresponding Cmax if data permit.;Timepoint(s) of evaluation of this end point: Vital signs (BP, HR), Height, weight: From Screening (-4 weeks to Day 1) to Follow-up (week 56) Hgb (full blood count): From Screening (-4 weeks to Day 1) to Follow-up (week 56) PK Sampling (Optional unless in the Integrated PK Phase): Day 1, Week 2, Week 4

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Countries

Argentina, Australia, Austria, Belgium, Canada, France, Germany, Italy, Japan, Korea, Republic of, Netherlands, Poland, Spain, Turkey, United Kingdom, United States

Contacts

Public ContactClinical Trials Help Desk

GlaxoSmithKline Research & Development Limited

GSKClinicalSupportHD@gsk.com+440800783 9733

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026