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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Drug (incl. Placebo) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lanthanum Carbonate (Fosrenol, BAY77-1931) - chewable tablet | Drug | Patients in hemodialysis who have received Fosrenol for hyperphosphatemia. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse drug reactions in subjects who received Fosrenol | After Fosrenol administration, up to 8 years |
| Measure | Description | Time Frame |
|---|---|---|
| Timing of onset of common ADRs related to the priority survey items | The items are
| After Fosrenol administration, up to 8 years |
| Effect on bones: Alkaline phosphatase over time |
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Inclusion Criteria:
Exclusion Criteria:
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The target population of this study is patients who have received a prescription of Fosrenol on the basis of the decision of the physician. The study is expected to collect data of 3,000 patients in about 300 practices in Japan.
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Japan |
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| ID | Term |
|---|---|
| D054559 | Hyperphosphatemia |
| ID | Term |
|---|---|
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C119467 | lanthanum carbonate |
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| 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 |