This study will be conducted to assess the safety and tolerability of ferric citrate in pediatric participants with hyperphosphatemia related to chronic kidney disease (CKD).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
45
oral tablets
University of Alabama at Birmingham (UAB) - Children's of Alabama
Birmingham, Alabama, United States
Phoenix Childrens Hospital
Phoenix, Arizona, United States
Number of participants with serious and non-serious treatment-emergent adverse events (TEAEs) including gastrointestinal (GI) AEs of special interest
Time frame: up to Week 40
Number of participants with clinically significant laboratory abnormalities or changes in laboratory results
Time frame: up to Week 40
Number of participants with TEAEs leading to the discontinuation of ferric citrate
Time frame: up to Week 40
Change from baseline in serum phosphorus to Week 12/early termination (ET)
Time frame: Baseline; up to Week 12
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University of California, San Francisco (UCSF) - Department of Nephrology
San Francisco, California, United States
Stanford University Medical Center
Stanford, California, United States
Children's Hospital Colorado
Aurora, Colorado, United States
University of South Florida
Tampa, Florida, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Children's Mercy Hospital - Kansas City
Kansas City, Missouri, United States
...and 4 more locations