drugset / Trial / NCT04925011
Investigating the Efficacy and Safety of Roxadustat (FG-4592) for Treatment of Anemia in Pediatric Patients With CKD
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 | — |