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To evaluate the effect and safety of a switch from phosphate binders to KHK7791 to treat Hyperphosphatemia in patients on HD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KHK7791 | Experimental | Patients start at KHK7791 30 mg BID and can down titrate weekly to 20, 15, 10, and 5 mg BID, sequentially based on a GI tolerability question. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KHK7791 | Drug | KHK7791 30 mg, 20 mg ,10 mg or 5 mg tablets |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects who reduce the total number of taking phosphate binder tablets at the last assessment from baseline. | Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Serum phosphorus levels at each time point after the start of treatment | up to Week 26 | |
| Corrected serum calcium level at each time point after the start of treatment | up to Week 26 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Study Site 1 | Niigata | 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 |
|---|---|
| C000599417 | tenapanor |
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