Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| FOSRENOL-PRED | Other Identifier | company internal |
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 who have received Fosrenol.
The objective of this research is to collect information on the safety of Fosrenol after its launching, which means collecting information on adverse events, especially adverse events in the digestive system including constipation and serious adverse events, and adverse drug reactions when the drug is administered to the below-mentioned target patients for six months.
The secondary objective is to collect information on the safety of the drug when administered for more than six months, which means collecting information on the safety of the drug when administered for up to 12 months to the target patients who have already been treated with the drug for six months. And also if at the time of 12 months after administration of Lanthanum carbonate the dialysis is not conducted, extending its' administration will be continued until conduction of dialysis, or until Sept. 30, 2015. The efficacy of fosrenol is evaluated by observing the serum P(phosphorus) level and serum PTH (parathyroid hormone) level change.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lanthanum Carbonate (Fosrenol, BAY77-1931) | Drug | Patients treated with Fosrenol in daily clinical practice. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence/number of episodes of adverse drug reactions and adverse events | 6 months after start of treatment with the drug |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence/number of episodes of adverse drug reactions and adverse events | until the conduction of dialysis after starting the treatment with Lanthanum carbonate(Maximum 2 years) | |
| Adverse drug event rate related to the digestive system | until the conduction of dialysis(Maximum 2 years) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Chronic renal failure patients who have not been treated with dialysis and will be treated with Fosrenol for hyperphosphatemia
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 |
| D007674 | Kidney Diseases |
| ID | Term |
|---|---|
| D010760 | Phosphorus Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014570 | Urologic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C119467 | lanthanum carbonate |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Incidence/number of episodes of adverse events for 6, 12 months ,and from month 13 to the conduction of dialysis after starting the treatment with Lanthanum carbonate. | until the conduction of dialysis(Maximum 2 years) |
| Incidence/number of episodes of adverse drug reactions for 6, 12 months ,and from month 13 to the conduction of dialysis after starting the treatment with Lanthanum carbonate according to patient characteristics and treatment with Lanthanum carbonate. | until the conduction of dialysis(Maximum 2 years) |
| Serum P level for six months after start of treatment with the drug in comparison with baseline (at the time of start of treatment with fosrenol) | 6 months after start of treatment with the drug |
| Serum intact PTH level for six months after start of treatment with the drug in comparison with baseline | 6 months after start of treatment with the drug |
| Serum P level at 12 months after starting the treatment with Lanthanum carbonate in comparison with baseline (at the time of starting the treatment with Fosrenol). | 12 months |
| Serum P level at the conduction of dialysis from 13 months after starting the treatment with Lanthanum carbonate in comparison with baseline (at the time of starting the treatment with Fosrenol). | until the conduction of dialysis(Maximum 2 years) |
| Serum intact PTH level at 12 months after starting the treatment with Lanthanum carbonate in comparison with baseline (at the time of starting the treatment with Lanthanum carbonate). | 12 months |
| Serum intact PTH level at the conduction of dialysis from 13 months after starting the treatment with Lanthanum carbonate in comparison with baseline (at the time of starting the treatment with Lanthanum carbonate). | until the conduction of dialysis(Maximum 2 years) |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |