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To evaluate the safety and efficacy of treatment with SK-1403 for 52 weeks in patients with secondary hyperparathyroidism on maintenance hemodialysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SK-1403 | Experimental | Patients receive SK-1403 three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (52 weeks), with individual dose adjustment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SK-1403 | Drug | Patients receive SK-1403 three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (52 weeks), with individual dose adjustment. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with adverse events or adverse drug reactions | Number of participants with adverse events or adverse drug reactions | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of participants who achieved a serum iPTH level of ≥ 60 pg/mL and ≤ 240 pg/mL at each time point | Rate of participants who achieved a serum iPTH level of ≥ 60 pg/mL and ≤ 240 pg/mL at each time point; Assessed by laboratory test value | 52 weeks |
| Measured values and Changes from baseline in serum PTH, Ca, ionized Ca, P, and serum Ca x P product |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational site (there may be other sites in this country) | 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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Measured values and Changes from baseline in serum PTH, Ca, ionized Ca, P, and serum Ca x P product; Assessed by laboratory test value |
| 52 weeks |