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To evaluate the efficacy of KHK7791 in combination with phosphate binders by comparing changes in serum phosphorus levels between hemodialysis patients with hyperphosphatemia receiving repeated administration of KHK7791 30 mg in combination with phosphate binders for 6 weeks and those receiving placebo in combination with phosphate binders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KHK7791 | Active Comparator | During the dosing period, subjects administer the study drug (KHK7791 or placebo) twice daily just before meals in a double blind. The starting dose of the study drug is 5 mg at a time, and the dose is adjusted in the range of 5, 10, 20, and 30 mg at a time based on the dose adjustment criteria described in the study protocol. Dosage adjustment is performed step by step. |
|
| Placebo | Placebo Comparator | During the dosing period, subjects administer the study drug (KHK7791 or placebo) twice daily just before meals in a double blind. The starting dose of the study drug is 5 mg at a time, and the dose is adjusted in the range of 5, 10, 20, and 30 mg at a time based on the dose adjustment criteria described in the study protocol. Dosage adjustment is performed step by step. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KHK7791 | Drug | oral administration |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in serum phosphorous levels from baseline values at 8 weeks after the start of administration. | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in serum phosphorous levels from baseline values at each time point. | Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8. | |
| Achievement/failure of the target serum phosphorus level (serum phosphorus level: ≤ 6.0). | Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inoue Hospital | Suita | Osaka | 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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| Drug |
oral administration |
|
| Time when the target serum phosphorus level (serum phosphorus level: ≤ 6.0) was achieved. | Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8. |
| Achievement/failure of the target serum phosphorus level (serum phosphorus level: ≤ 5.5). | Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8. |
| Time when the target serum phosphorus level (serum phosphorus level: ≤ 5.5) was achieved. | Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8. |
| Concentrations of such as Ca × P product levels at each time point. | Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8. |
| Changes of such as Ca × P product levels from baseline values at each time point. | Dose period, Week 1, 2, 3, 4, 5, 6, 7, 8. |