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This is a multicenter, single-arm, long-term safety and tolerability trial. A total of 300 subjects with chronic kidney disease on hemodialysis are planned to be enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHR6508 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHR6508 | Drug | SHR6508 will be administered to all the eligible subjects |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of any adverse events that occurred during the clinical study | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Percent change from baseline in predialysis iPTH during the EAP | through study completion, an average of 1 year | |
| Percent change from baseline in predialysis serum cCa during the EAP | through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Beijing | Beijing Municipality | 100044 | China |
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| Percent change from baseline in predialysis serum phosphorus during the EAP | through study completion, an average of 1 year |
| Percent change from baseline in predialysis calcium-phosphorus product during the EAP | through study completion, an average of 1 year |
| ID | Term |
|---|---|
| D006962 | Hyperparathyroidism, Secondary |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
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