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This study is designed to evaluate safety, pharmacokinetics and pharmacodynamics after single administration of KHK7580 for secondary hyperparathyroidism in patients receiving peritoneal dialysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KHK7580 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KHK7580 | Drug | Oral administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and types of adverse events | The safety of KHK7580 assessed by number and types of adverse events, laboratory tests, vital signs and electrocardiogram | For 8 days |
| Measure | Description | Time Frame |
|---|---|---|
| Profiles of pharmacokinetics | intact parathyroid hormone, whole parathyroid hormone, corrected serum calcium, phosphorus, intact fibroblast growth factor 23, ionized calcium, calcitonin | Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48, 72 and 168 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyowa Hakko Kirin | Tokyo | Japan |
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| ID | Term |
|---|---|
| D006962 | Hyperparathyroidism, Secondary |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
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