Hyperphosphatemia
Conditions
Keywords
Fosrenol, Hyperphosphatemia, Hemodialysis
Brief summary
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.
Interventions
Patients in hemodialysis who have received Fosrenol for hyperphosphatemia.
Sponsors
Bayer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients undergoing hemodialysis who received Fosrenol for hyperphosphatemia
Exclusion criteria
* Patients who are contraindicated based on the product label
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of adverse drug reactions in subjects who received Fosrenol | After Fosrenol administration, up to 8 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Timing of onset of common ADRs related to the priority survey items | After Fosrenol administration, up to 8 years | The items are * Gastrointestinal symptoms * Secondary hyperparathyroidism * Hypocalcaemia and decreased blood calcium |
| Effect on bones: Alkaline phosphatase over time | After Fosrenol administration, up to 8 years | — |
| Effect on bones: Change in bone density | After Fosrenol administration, up to 8 years | — |
| Cardiothoracic ratio over time | After Fosrenol administration, up to 8 years | — |
| PWV and ABI over time | After Fosrenol administration, up to 8 years | — |
| Serum P, albumin-corrected serum Ca and serum intact PTH, and Ca-P product over time | After Fosrenol administration, up to 8 years | — |
| Percentage of patients achieving the serum P control goal | After Fosrenol administration, up to 8 years | — |
Countries
Japan
Outcome results
None listed