A 36-WEEK, SINGLE-ARM, OPEN-LABEL STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF FERRIC CITRATE IN CHILDREN WITH HYPERPHOSPHATEMIA RELATED TO CHRONIC KIDNEY DISEASE
What is the goal of the study?
This is a clinical research study for children and teenagers with hyperphosphatemia from chronic kidney disease (CKD). The goal is to find out if the study medication can safely lower the amount of phosphate in the blood of children and teenagers.The study medication (brand name Auryxia®) is approved by the US Food and Drug Administration (FDA) for the control of serum phosphorus levels in adults with CKD on dialysis. However, the study medication is considered investigational in this study because it has not been approved by the FDA to be used in people younger than age 17. This study is to find out if the study medication is also safe for people from 12 to 17 years of age. Inclusion: ? 12 to < 17 years of age ? diagnosed with CKD that requires dialysis, or not on dialysis with eGFR less than 30 mL/min/1.73 m2 ? if taking phosphate binders, must stop before joining.
Who can participate in the study?
Please contact the study team listed below to learn more.