NCT04621331

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

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Kyntra Bio · Industry
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anemia Associated With Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	Roxadustat	HIF-PH inhibitor for treatment of anemia in CKD

Timeline

• Start date: 2022-05-23
• Primary completion: 2022-05-23
• Completion: 2022-05-23
• First posted: 2020-11-09
• Last updated: 2022-07-05

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study