Anemia Studies in CKD: Erythropoiesis via a Novel PHI Daprodustat -Pediatric (ASCEND-P)

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

JPRN

Registry ID

JPRN-jRCT2041220113

Enrollment

Registered

2022-12-26

Start date

2023-09-27

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Renal anemia

Interventions

All participants will receive oral daprodustat for a total of 52 weeks and will be followed for an additional 4 weeks after completing treatment. The lowest dose level defined (0.125 mg once daily [QD

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: - Participant must be 3 months to less than (<)18 years of age. - Anemia associated with CKD stage 3, 4, 5 (not on dialysis) or who have dialysis-dependent CKD, defined as Hgb 7.0 to 11.0 g/dL (if not using erythropoiesis stimulating agents [ESAs]) or Hgb 9.5 to 12.0 g/dL if using ESAs. - Written informed consent or assent as appropriate.

Exclusion criteria

Exclusion criteria: Exclusion Criteria: - Kidney transplant recipient with a functioning allograft. - Scheduled for elective kidney transplantation within 3 months. - Transferrin saturation (TSAT) 2x upper limit of normal (ULN), bilirubin >1.5x ULN (unless bilirubin is fractionated and direct bilirubin <35%), and cirrhosis or current unstable liver or biliary disease.

Design outcomes

Primary

Measure	Time frame
Describe the safety of daprodustat, overall (all ages) and in each age group. - Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and AEs leading to study intervention discontinuation.	—

Countries

Argentina, Australia, Belgium, Canada, France, Germany, Italy, Japan, Netherlands, Poland, Russia, South Korea, Spain, Turkey, UK, US

Contacts

Public ContactKatsuya Fujii

Syneos Health Japan K.K.

chiken@syneoshealth.com+81-3-6733-9690

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026