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This long-term study is designed to evaluate safety and efficacy of KHK7580 orally administered once daily for 52 weeks for patients with secondary hyperparathyroidism receiving hemodialysis.
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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 of participants with adverse events | Adverse Event collection and assessment | Up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects achieving intact parathyroid hormone (PTH) level of ≥ 60 pg/mL and ≤ 240 pg/mL | Up to 52 weeks | |
| Percentage of subjects achieving a mean percent decrease in intact PTH level of ≥ 30% (percent change ≤ -30%) from baseline | Up to 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| For additional information regarding investigative sites for this trial, contact 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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| Mean percent change in intact PTH level from baseline | Up to 52 weeks |