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Ferric Citrate and Chronic Kidney Disease in Children
Sponsor: University of California, Los Angeles
Summary
We will conduct a 12-month, double-blind, randomized, placebo-controlled trial to assess the effects of therapy with ferric citrate (FC) on changes in intact FGF23 levels (iFGF23, primary endpoint) in 160 pediatric patients (80 in each of the two arms) aged 6-18 years of either sex with chronic kidney disease (CKD) stages 3-4 and age-appropriate normal serum phosphate levels. Participants will be randomized to one of the two groups: 1) FC or 2) FC placebo. Participants will be recruited from 20 core clinical sites.
Official title: Phosphate Binder Therapy and Chronic Kidney Disease in Children
Key Details
Gender
All
Age Range
6 Years - 18 Years
Study Type
INTERVENTIONAL
Enrollment
160
Start Date
2022-06-17
Completion Date
2027-10
Last Updated
2025-05-02
Healthy Volunteers
No
Conditions
Interventions
Ferric Citrate
Auryxia® 210 mg ferric iron tablets equivalent to 1 g of FC will be supplied as 200 tablets in 400cc high-density polyethylene bottles.
Placebo
Placebo to match Ferric Citrate tablets
Locations (20)
University of California, Los Angeles
Los Angeles, California, United States
Children's Hospital of Orange County
Orange, California, United States
University of California, San Francisco
San Francisco, California, United States
Arnold Palmer Hospital for Children
Orlando, Florida, United States
Emory University
Atlanta, Georgia, United States
Indiana U
Indianapolis, Indiana, United States
Children's Mercy Hospital, Kansas City
Kansas City, Missouri, United States
Washington U
St Louis, Missouri, United States
Cohen's Childrens
New York, New York, United States
Children's Hospital at Montefiore
The Bronx, New York, United States
Duke
Durham, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Nationwide Children's
Columbus, Ohio, United States
OHSU
Portland, Oregon, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Medical Center, Dallas
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
UTH
Houston, Texas, United States
BC Children's Hospital Research Institute
Vancouver, British Columbia, Canada
SickKids
Toronto, Ontario, Canada