Study of Roxadustat to Treat Anemia in Children and Teenagers with Chronic Kidney Disease Phase 3 Open-label Trial Evaluating Safety and Effects on Blood Levels

What this Trial Is About

Researchers are evaluating roxadustat, an oral medicine, for treating anemia in children and teenagers with chronic kidney disease CKD. Anemia involves low red blood cell levels, and current treatments often use injections called erythropoietin stimulating agents ESAs with iron, but these have safety concerns. This Phase 3 open-label study aims to understand how roxadustat affects anemia in this young population, offering a potential alternative to ESA injections. Participants will take roxadustat orally or via gastric tube three times a week for up to 52 weeks. The study begins with a fixed dose for 4 weeks, during which blood hemoglobin levels are regularly checked to adjust dosing as needed to maintain target levels just below normal. The study starts with 10 teenagers and 10 children who receive fixed doses to determine appropriate dosing for others. After this, the remaining children and teenagers will take the optimized dose. Children and teenagers will visit the clinic frequently every 2 weeks during the first month and then every 4 weeks until the treatment ends, with a final visit 4 weeks after stopping roxadustat. At visits, vital signs, fluid status for dialysis patients, blood and urine tests, and medical exams will be conducted, including electrocardiograms at specific intervals. Researchers will monitor hemoglobin, iron levels, safety, growth, and quality of life over the study period, which may last up to 56 weeks including follow-up.

A Study of Roxadustat to Treat Anemia in Children and Teenagers With Chronic Kidney Disease