This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients in hemodialysis who received Fosrenol for hyperphosphatemia. The objective of this study is to assess safety and efficacy of using Fosrenol in clinical practice. A total 3,000 patients will be recruited and followed 5 years.
Study Type
OBSERVATIONAL
Enrollment
3,267
Patients in hemodialysis who have received Fosrenol for hyperphosphatemia.
Unnamed facility
Multiple Locations, Japan
Incidence of adverse drug reactions in subjects who received Fosrenol
Time frame: After Fosrenol administration, up to 8 years
Timing of onset of common ADRs related to the priority survey items
The items are * Gastrointestinal symptoms * Secondary hyperparathyroidism * Hypocalcaemia and decreased blood calcium
Time frame: After Fosrenol administration, up to 8 years
Effect on bones: Alkaline phosphatase over time
Time frame: After Fosrenol administration, up to 8 years
Effect on bones: Change in bone density
Time frame: After Fosrenol administration, up to 8 years
Cardiothoracic ratio over time
Time frame: After Fosrenol administration, up to 8 years
PWV and ABI over time
Time frame: After Fosrenol administration, up to 8 years
Serum P, albumin-corrected serum Ca and serum intact PTH, and Ca-P product over time
Time frame: After Fosrenol administration, up to 8 years
Percentage of patients achieving the serum P control goal
Time frame: After Fosrenol administration, up to 8 years
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