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This randomized, placebo-controlled, double-blind (included open arm of KRN1493 (cinacalcet)), parallel-group, multi-center study is designed to evaluate efficacy and safety in cohorts comprising KHK7580, its placebo and KRN1493 (cinacalcet) orally administered for three weeks for secondary hyperparathyroidism patients receiving hemodialysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plascebo | Placebo Comparator |
| |
| KHK7580 low dose | Experimental |
| |
| KHK7580 middle dose | Experimental |
| |
| KHK7580 high dose | Experimental |
| |
| KRN1493 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Oral administration |
| |
| KHK7580 low dose |
| Measure | Description | Time Frame |
|---|---|---|
| The percent changes in intact Parathyroid hormone levels from baseline | Percent changes in intact Parathyroid hormone levels from baseline to end of administration period | Up to 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in intact Parathyroid hormone , whole Parathyroid hormone, corrected serum Ca, ionized Ca, serum phosphorus, intact fibroblast growth factor 23 and corrected serum Ca X serum phosphorus. | Change from baseline in intact Parathyroid hormone , whole Parathyroid hormone, corrected serum Ca, ionized Ca, serum phosphorus, intact fibroblast growth factor 23 and corrected serum Ca X serum phosphorus from baseline to end of administrations period. |
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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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| ID | Term |
|---|---|
| D000069449 | Cinacalcet |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| Drug |
Oral administration |
|
| KHK7580 middle dose | Drug | Oral administration |
|
| KHK7580 high dose | Drug | Oral administration |
|
| KRN1493 | Drug | Oral administration |
|
|
| Up to 3 weeks |
| Safety |
| Up to 3 weeks |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |