NCT04925011

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

An Open-label, One-center Study Investigating the Efficacy and Safety of Roxadustat (FG-4592) for Treatment of Anemia in Pediatric Patients With Chronic Kidney Disease

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Mao Jianhua · Academic / Other
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is to evaluate the use of roxadustat for renal anemia in pediatric patients with CKD

Conditions

• Anemia Associated With Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	Roxadustat	Starting doses of 20, 50, 70 or 100 mg/30,70,90,or 120mg based on weight and dialysis or not.

Timeline

• Start date: 2021-09-01
• Primary completion: 2022-06-30
• Completion: 2022-12-30
• First posted: 2021-06-14
• Last updated: 2021-08-09

Locations

1 site across 1 country: China