drugset / Trial / NCT04925011

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

NCT04925011

Phase 3 Unknown 30 enrolled Mao Jianhua
NaSingle-groupOpen-labelTreatment

Summary

This open-labeled, one-center study is designed to evaluate the efficacy and safety of roxadustat in ESA-naïve and ESA-treated pediatric patients with CKD Stages 3, 4, and 5 who are receiving dialysis or not. The study will enroll patients between the ages of 2 to \<18 years. Approximately 30 patients will be enrolled.

Timeline

Start
2021-09-01
Primary completion
2022-06-30
Completion
2022-12-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Roxadustat Small molecule 20 mg
Subject Roxadustat Small molecule 30 mg
Subject Roxadustat Small molecule 50 mg
Subject Roxadustat Small molecule 70 mg
Subject Roxadustat Small molecule 90 mg
Subject Roxadustat Small molecule 100 mg
Subject Roxadustat Small molecule 120 mg