Investigating the Efficacy, Safety and PK of Roxadustat (FG-4592) for Treatment of Anemia in Pediatric Patients With CKD
Withdrawn before enrolling · Phase 3
Conditions studied: Anemia Associated With Chronic Kidney Disease
In brief
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.
Key facts
- Study ID
- NCT04621331
- Run by
- Kyntra Bio
- People needed
- 0
- Starts
- 2022-05-23
- Expected to finish
- 2022-05-23
- Last updated by the study team
- 2022-07-05
Who can join
Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Ann and Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
- University of Nebraska Medical Center — Omaha, Nebraska, United States
- Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH) — New York, New York, United States
- Investigative site — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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