| Outcome Measures: |
Primary: iFGF23 levels, Compared to placebo, active treatment with FC will lower iFGF23 levels, 3 to 12 months|Safety of Ferric Citrate, Therapy with FC will be safe compared with placebo, 12 months|Tolerability of Ferric Citrate, Compared with placebo, active treatment will be tolerable, 12 months | Secondary: Effects on Transferrin Saturation (TSAT), Compared with placebo, active treatment with FC will be associated with larger increase in hemoglobin, higher TSAT and higher Ferritin from baseline, 12 months|Effects on PTH and 1,25 D, Compared to placebo, active treatment with FC will be associated with a larger decrease in PTH and larger increase in 1,25 D from baseline, 12 months|Effects on GFR, Compared to placebo, active treatment with FC will be associated with smaller decrease in GFR over time, 12 months|Effects on Osteoid thickness, Compared to placebo, active treatment with FC will be associated with a larger decrease of osteoid thickness from baseline, 12 months|Effects on phosphate, Compared to placebo, active treatment with FC will be associated with a greater reduction in 24 hours urinary phosphate and fractional excertion of phosphate, 12 months|Effects on bone expression, Compared to placebo, active treatment with FC will be associated with a greater reduction in bone expression of FGF23, 12 months|Effects on calcium, Compared to placebo, active treatment with FC will be associated with a greater incresae in serum calcium levels from baseline, 12 months|Effects on 25 (OH) D levels, Compared to placebo, active treatment with FX will be associated with a greater increase from baseline in serum 25 (OH) D levels, 12 months|Effects on bone biomarkers, Compared to placebo, active treatment with FC will be associated with greater reduction from baseline of bone biomarkers of turnover, 12 months|Effects on Klotho, Compared to placebo, active treatment with FC will be associated with greater reduction from baseline in levels of Klotho, 12 months|Effects on cFGF23, Compared to placebo, active treatment with FC will be associated with greater reduction from baseline in cFGF23, 12 months
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| Locations: |
University of California, Los Angeles, Los Angeles, California, 90095, United States|Children's Hospital of Orange County, Orange, California, 92868, United States|University of California, San Francisco, San Francisco, California, 94143, United States|Arnold Palmer Hospital for Children, Orlando, Florida, 32806, United States|Emory University, Atlanta, Georgia, 30322, United States|Indiana U, Indianapolis, Indiana, 46202, United States|Children's Mercy Hospital, Kansas City, Kansas City, Missouri, 64110, United States|Washington U, Saint Louis, Missouri, 63130, United States|Cohen's Childrens, New York, New York, 11040, United States|Children's Hospital at Montefiore, The Bronx, New York, 10467, United States|Duke, Durham, North Carolina, 27708, United States|Cincinnati Children's Hospital Medical Center, Cincinnati, Ohio, 45229, United States|Nationwide Children's, Columbus, Ohio, 43205, United States|OHSU, Portland, Oregon, 97239, United States|Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, 19104, United States|Children's Medical Center, Dallas, Dallas, Texas, 75235, United States|Baylor College of Medicine, Houston, Texas, 77030, United States|UTH, Houston, Texas, 77030, United States|UTH, Houston, Texas, 77030, United States|BC Children's Hospital Research Institute, Vancouver, British Columbia, V5Z 4H4, Canada|SickKids, Toronto, Ontario, M5G 1E8, Canada
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