Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients in continuous ambulatory peritoneal dialysis (CAPD) who have received Fosrenol for hyperphosphatemia. The objective of this study is to assess safety and efficacy of using Fosrenol in clinical practice. This study is also all case investigation of which the enrollment period is one year, and all patients in CAPD who received Fosrenol for hyperphosphatemia will be recruited and followed one year.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 CAPD 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 1 year | |
| Incidence of serious adverse events in subjects who received Fosrenol | After Fosrenol administration, up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse drug reactions in subpopulation with baseline data [such as demographic data, concomitant disease, duration of treatment, maximum daily dose] and dose of Fosrenol | After Fosrenol administration, up to 1 year | |
| Effectiveness evaluation assessment [achievement rate of a goal phosphate level; 3.5-6 mg/dL] |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
This study is all case investigation of which the enrollment period is one year, and all patients in CAPD who received Fosrenol for hyperphosphatemia will be recruited.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Locations | Japan |
Not provided
| ID | Term |
|---|---|
| D054559 | Hyperphosphatemia |
| ID | Term |
|---|---|
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C119467 | lanthanum carbonate |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| After Fosrenol administration, up to 1 year |
| Effectiveness evaluation assessment [achievement rate of a goal calcium level; 8.4-10.0 mg/dL] | After Fosrenol administration, up to 1 year |
| Clinical test value collections [calciotropic hormones, bone turnover markers] | After Fosrenol administration, up to 1 year |