The purpose of the study is to determine the effect and optimum dose and evaluate the safety of ferric citrate, administered three times daily (TID) immediately after meals for a total daily dose of 4 or 6 grams for 56 days, on serum phosphate (PO4) levels in subjects with end stage renal disease (ESRD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
183
0g/day ferric citrate capsule, TID for 56 days
4g/day ferric citrate capsule, TID for 56 days
6 g/day ferric citrate capsule, TID for 56 days
Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang-Gung Memorial Hospital
Kaohsiung City, Taiwan
Division of Nephrology, Keelung Chang Gung Memorial Hospital
Keelung, Taiwan
Division of Nephrology, Department of Internal Medicine, Far East Memorial Hospital
New Taipei City, Taiwan
Division of Nephrology, Department of Internal Medicine, Taichung Veterans General Hospital
Taichung, Taiwan
Change in serum phosphorus at Day 56 as compared to baseline
Time frame: Day 56
Change in serum phosphorus at Day 28 as compared to baseline
Time frame: Day 28
Change in Ca x P product at Day 56 compared to baseline
Time frame: Day 56
Change in Ca x P product at Day 28 compared to baseline
Time frame: Day 28
Cumulative drop out rate due to serum phosphorus concentration >9mg/dL at Day 56
Time frame: Day 56
Cumulative drop out rate due to serum Phosphorus concentration >9mg/dL at Day 28
Time frame: Day 28
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Division of Nephrology, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan