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A phase 2, randomized, placebo-controlled, double-blind, dose-finding study of TS-172 in hyperphosphatemia patients on hemodialysis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 10 mg bid | Experimental | Patients receive TS-172 10 mg bid. |
|
| 30 mg bid | Experimental | Patients receive TS-172 30 mg bid. |
|
| 60 mg bid | Experimental | Patients receive TS-172 60 mg bid. |
|
| 20 mg tid | Experimental | Patients receive TS-172 20 mg tid. |
|
| Placebo | Placebo Comparator | Patients receive placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TS-172 10mg bid | Drug | oral administration of TS-172 10 mg bid |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in serum concentration of phosphorus | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Achievement ratio of patients with the target serum concentration of phosphorus | Up to Week 4 | |
| Concentration of corrected serum calcium | Up to Week 4 | |
| Serum calcium times phosphorus product |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Taisho Director | Taisho Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taisho Pharmaceutical Co., Ltd selected site | Tokyo | Japan |
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| ID | Term |
|---|---|
| C494814 | BID protein, human |
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| TS-172 30mg bid |
| Drug |
oral administration of TS-172 30 mg bid |
|
| TS-172 60mg bid | Drug | oral administration of TS-172 60 mg bid |
|
| TS-172 20mg tid | Drug | oral administration of TS-172 20 mg tid |
|
| Placebo | Drug | oral administration of placebo |
|
| Up to Week 4 |