Investigating the Efficacy, Safety and PK of Roxadustat (FG-4592) for Treatment of Anemia in Pediatric Patients With CKD

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.

Timeline

Start

2022-05-23

Primary completion

2022-05-23

Completion

2022-05-23

Drugs

Indications