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This is a randomized, positive controlled, and placebo-controlled phase II clinical study to evaluate the efficacy and safety of MT1013 injection in the treatment of chronic kidney disease with secondary hyperparathyroidism (SHPT) undergoing maintenance hemodialysis (MHD) subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MT1013 dose regimen 1 | Experimental | MT1013 injection dose regimen 1 administered intravenously (IV) three times per week for 26 weeks. |
|
| MT1013 dose regimen 2 | Experimental | MT1013 injection dose regimen 2 administered intravenously (IV) three times per week for 26 weeks. |
|
| Etelcalcetide | Active Comparator | Etelcalcetide injection administered intravenously (IV) three times per week for 26 weeks. |
|
| Placebo | Placebo Comparator | Placebo administered intravenously (IV) three times per week for 26 weeks; |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT1013 | Drug | MT1013 is a novel calcimimetic agent |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with > 30% reduction from baseline in mean iPTH during the efficacy assessment phase | Weeks 22 to 27, inclusive |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with > 50% reduction from baseline in mean iPTH during the efficacy assessment phase | Weeks 22 to 27, inclusive |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital College of Medicine, Zhejiang University | Hangzhou | Zhejiang | 310003 | China |
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| MT1013 |
| Drug |
MT1013 is a novel calcimimetic agent |
|
| Etelcalcetide Hydrochloride | Drug | the already-marketed therapeutic agents |
|
| Placebo | Drug | The measure does not contain the active ingredients |
|
| ID | Term |
|---|---|
| D006962 | Hyperparathyroidism, Secondary |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C583569 | etelcalcetide hydrochloride |
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