Last updated: 09/17/2025 15:20:17
Anemia Studies in CKD: Erythropoiesis via a Novel PHI Daprodustat - Pediatric (ASCEND-P)ASCEND-P
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: 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
Trial description: 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.
Primary purpose:
Treatment
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Number of participants with adverse events (AEs) and serious adverse events (SAEs)
Timeframe: Up to 56 weeks
Number of participants with adverse event of special interests (AESIs)
Timeframe: Up to 56 weeks
Number of participants with AEs leading to study intervention discontinuation
Timeframe: Up to 52 weeks
Secondary outcomes:
Number of participants with change from baseline in laboratory safety parameters
Timeframe: Baseline (Day 1) and up to Week 56
Mean change from baseline in blood pressure (BP)
Timeframe: Baseline (Day 1) and up to Week 56
Mean change from baseline in heart rate (HR)
Timeframe: Baseline (Day 1) and up to Week 56
Mean change from baseline in weight
Timeframe: Baseline (Day 1) and up to Week 56
Mean change from baseline in height
Timeframe: Baseline (Day 1) and up to Week 56
Mean Hgb value
Timeframe: Up to Week 56
Mean change from baseline in Hgb values
Timeframe: 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)
Timeframe: Up to week 56
Mean daprodustat dose
Timeframe: Up to Week 56
Number of participants with 0 to 10, or greater than [>] 10 dose adjustments
Timeframe: Up to Week 56
Number of participants assigned to each dose level at each visit
Timeframe: Up to Week 56
Maximum plasma concentration (Cmax) of daprodustat and its metabolites
Timeframe: Up to Week 4
Area under the curve (AUC) at steady state of daprodustat and its metabolites
Timeframe: Up to Week 4
Plasma concentrations of daprodustat metabolites at pre-dose trough (Ctrough)
Timeframe: Up to Week 4
Interventions:
Enrollment:
4
Primary completion date:
2024-18-10
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Anaemia
Product
daprodustat
Collaborators
Not applicable
Study date(s)
September 2023 to March 2025
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
3 Months - 17 Years
Accepts healthy volunteers
No
- 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.
- Kidney transplant recipient with a functioning allograft.
- Scheduled for elective kidney transplantation within 3 months.
Inclusion and exclusion 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:
- Kidney transplant recipient with a functioning allograft.
- Scheduled for elective kidney transplantation within 3 months.
- Transferrin saturation (TSAT) < 20 percent (%), or Ferritin <25 nanogram (ng)/milliliter (mL).
- History of bone marrow aplasia or pure red cell aplasia.
- Active hemolysis.
- Other causes of anemia.
- 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.
- 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.
Trial location(s)
Showing 1 - 6 of 12 Results
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2024-18-10
Actual study completion date
2025-17-03
Plain language summaries
Summary of results in plain language
Available language(s): English, Japanese, Korean
To view plain language summaries on trialsummaries.com click here.
Additional information about the trial
Additional information
Not applicable
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