To assess the long-term safety and effectiveness of Nephoxil® for the treatment of hyperphosphatemia in patients with ESRD undergoing dialysis.
This study is an open-label, prospective, long term, Phase IV study to assess the safety and efficacy of Nephoxil® in subjects with ESRD on dialysis.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
202
Ferric citrate will be provided as a 500mg capsule. All intervention doses will be based on serum phosphorus levels.
Division of Nephrology, Department of Internal Medicine, Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
Division of Nephrology, Department of Internal Medicine, Kaohsiung Chang-Gung Memorial Hospital
Kaohsiung City, Taiwan
Division of Nephrology, Department of Internal Medicine, Keelung Chang Gung Memorial Hospital
Number of subjects with treatment-emergent adverse events (TEAEs)
Number of subjects with treatment-emergent adverse events (TEAEs)
Time frame: 13 months
Percentage of subjects with treatment-emergent adverse events (TEAEs)
Percentage of subjects with treatment-emergent adverse events (TEAEs)
Time frame: 13 months
Serum Phosphorus
Serum Phosphorus will be assessed by time-course changes of serum phosphorus levels and proportion of subjects achieved target range of serum phosphorus (\>=3.5 mg/dL and \<=5.5. mg/dL) from baseline to the end-of-treatment.
Time frame: 13 months
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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
Division of Nephrology, Department of Internal Medicine, National Taiwan University Hospital
Taipei, Taiwan
Division of Nephrology, Department of Internal Medicine, Taipei Medical University Hospital
Taipei, Taiwan
Division of Nephrology, Department of Internal Medicine, Shin Kong Wu Ho-Su Memorial Hospital
Taipei, Taiwan
Division of Nephrology, Department of Internal Medicine, Taipei Veterans General Hospital
Taipei, Taiwan