Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Kyowa Kirin China Pharmaceutical Co., Ltd. | INDUSTRY |
| Kyowa Kirin Korea Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the efficacy and the safety of KHK7580 orally administered once daily for 52 weeks compared to cinacalcet hydrochloride as an active control in subjects with secondary hyperparathyroidism receiving hemodialysis in China, Korea, Hong Kong and Taiwan.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KHK7580 1mg-12mg | Experimental |
| |
| Cinacalcet 25mg-100mg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KHK7580 | Drug | oral administration |
| |
| Cinacalcet Hydrochloride |
| Measure | Description | Time Frame |
|---|---|---|
| Mean percent change in intact parathyroid hormone (PTH) level from baseline in the evaluation period | Week 50- Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects achieving a mean intact PTH level of ≧150pg/mL and ≦300pg/mL in the evaluation period | Week 50- Week 52 | |
| Percentage of subjects achieving a mean intact PTH level of ≧150pg/mL and ≦300pg/mL in the evaluation period | Week 50- Week 52 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research site_29 | Changsha | China | ||||
| Research site_34 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
oral administration |
|
| Number of subjects achieving a mean percent decrease in intact PTH level of ≧30% (percent change ≦-30%) from baseline in the evaluation period | Week 50- Week 52 |
| Percentage of subjects achieving a mean percent decrease in intact PTH level of ≧30% (percent change ≦-30%) from baseline in the evaluation period | Week 50- Week 52 |
| Intact PTH level | Week 50- Week 52 |
| corrected serum Ca level | Week 50- Week 52 |
| serum P level | Week 50- Week 52 |
| Dalian |
| China |
| Research site_25 | Foshan | China |
| Research site_22 | Guangzhou | China |
| Research site_23 | Guangzhou | China |
| Research site_30 | Guangzhou | China |
| Research site_28 | Hefei | China |
| Research site_32 | Nanjing | China |
| Research site_33 | Nanjing | China |
| Research site_24 | Shanghai | China |
| Research site_26 | Shanghai | China |
| Research site_27 | Shanghai | China |
| Research site_31 | Wuxi | China |
| Research site_11 | Hong Kong | Hong Kong |
| Research site_21 | Anyang | South Korea |
| Research site_13 | Daegu | South Korea |
| Research site_15 | Daegu | South Korea |
| Research site_12 | Goyang | South Korea |
| Research site_18 | Incheon | South Korea |
| Research site_14 | Seoul | South Korea |
| Research site_17 | Seoul | South Korea |
| Research site_19 | Seoul | South Korea |
| Research site_20 | Seoul | South Korea |
| Research site_16 | Ulsan | South Korea |
| Research site_2 | Kaohsiung City | Taiwan |
| Research site_3 | Kaohsiung City | Taiwan |
| Research site_5 | Kaohsiung City | Taiwan |
| Research site_9 | Taichung | Taiwan |
| Research site_4 | Tainan | Taiwan |
| Research site_7 | Tainan | Taiwan |
| Research site_10 | Taipei | Taiwan |
| Research site_1 | Taipei | Taiwan |
| Research site_6 | Taipei | Taiwan |
| Research site_8 | Taipei | Taiwan |
| ID | Term |
|---|---|
| D006962 | Hyperparathyroidism, Secondary |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069449 | Cinacalcet |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
Not provided
Not provided