Investigating the Efficacy, Safety and PK of Roxadustat (FG-4592) for Treatment of Anemia in Pediatric Patients With CKD
Status:
Recruiting
Trial end date:
2024-07-31
Target enrollment:
Participant gender:
Summary
This open-labeled, multicenter study is designed to evaluate the efficacy, safety and PK/PD
of roxadustat in ESA-naïve and ESA-treated pediatric patients with CKD Stages 3, 4, and 5, as
well as end-stage renal disease (ESRD) who are receiving either hemodialysis (HD) or
peritoneal dialysis (PD). The study will enroll patients between the ages of 2 to <18 years
in two sequential cohorts, with the older cohort of ages 12 to <18 years enrolled first.
Approximately 30 patients will be enrolled in each age-based cohort.