NCT05682326CompletedPhase 3
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
Source: ClinicalTrials.gov · Last updated 10 Nov 2025
Brief summary (registry, in English)
This is an international, multicenter trial, evaluating pharmacokinetics (PK) (4 weeks), safety (52 weeks), and hemoglobin (Hgb) response (52 weeks) to daprodustat in children and adolescent participants with anemia associated with chronic kidney disease (CKD) incorporating 2 independent sub-trials (Non dialysis \[ND\] and Dialysis \[D\]). This study will enroll participants with anemia associated with CKD, in 2 distinct sub-populations differing only by their CKD stage and dialysis requirement (ND: CKD stage 3 to 5 not yet receiving dialysis and D: CKD stage 5d undergoing peritoneal dialysis \[PD\] or hemodialysis \[HD\]). The maximum duration of the study will be approximately 60 weeks, including Screening period (up to 4 weeks), treatment period (52 weeks), and follow-up period (4 weeks). Outcome measures are identical for the ND and D sub-trials, but will be separately assessed in each sub- trials, overall and within each age subgroups (12 to less than \[\<\] 18 years, 6 to \<12 years, 2 to \<6 years, and 3 months to \<2 years). Except for PK and dose change, which is within each age group only.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 4 (actual)
- First submitted
- 4 Jan 2023
- Start date
- 6 Sept 2023
- Primary completion date
- 18 Oct 2024
- Lead sponsor
- GlaxoSmithKline
- Diseases
- Chronic kidney disease
- NCT number
- NCT05682326
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 4
- From 6 Sept 2023 to the primary completion date, 18 Oct 2024
- 4 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Kidney transplant recipient with a functioning allograft.
- Scheduled for elective kidney transplantation within 3 months.
Other illness
- History of bone marrow aplasia or pure red cell aplasia.
- Active gastrointestinal bleeding within the last 4 weeks.
- Active or previous malignancy within the last 2 years.
- Acute or chronic infection requiring antimicrobial therapy.
- History of significant thrombotic or thromboembolic events within the last 8 weeks.
- Heart failure (HF) New York Heart Association (NYHA) Class IV
- Uncontrolled hypertension.
Lab values
- Alanine aminotransferase (ALT) \>2× upper limit of normal (ULN), bilirubin \>1.5× ULN (unless bilirubin is fractionated and direct bilirubin \<35%), and cirrhosis or current unstable liver or biliary disease.
Other
- Transferrin saturation (TSAT) \< 20 percent (%), or Ferritin \<25 nanogram (ng)/milliliter (mL).
- Active hemolysis.
- Other causes of anemia.
Who the study is looking for
- 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.
Age in the registry: 3 months to 17 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Aichi | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Saitama | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Tokyo | Japan | Unknown status |
| - Coordinator of this site? Confirm its status | Yangsan | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.