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This study is designed to evaluate safety, pharmacokinetics and pharmacodynamics after single and multiple administration of KHK7580 for secondary hyperparathyroidism in patients 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 |
|---|---|---|
| The safety of KHK7580 assessed by number and types of adverse events, laboratory tests, vital signs, electrocardiogram and ophthalmic examination | The safety of KHK7580 assessed by number and types of adverse events, laboratory tests, vital signs, electrocardiogram and ophthalmic examination | For 19 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Profiles of pharmacokinetics | Pharmacokinetic parameters such as Maximum concentration (Cmax), time to maximum concentration (tmax), area under the curve (AUC), half-life (t1/2), and etc., are assessed. | Pre-dose, 0.5, 1, 2, 4, 8, 12, 24, 48 and 72 hours post each single dosing, and pre-dose in Day 1, 3, 5, 8, 12 and 15 in multiple dose 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 |
|---|---|
| D006961 | Hyperparathyroidism |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
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| Profiles of pharmacodynamics | intact PTH, whole PTH, corrected serum calcium, phosphorus, intact FGF23, ionized calcium, calcitonin | For 4-15 days after every dosing |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |