Anemia Studies in CKD: Erythropoiesis Via a Novel PHI Daprodustat - Pediatric (ASCEND-P)
Status:
Not yet recruiting
Trial end date:
2026-08-20
Target enrollment:
Participant gender:
Summary
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.