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MT1013 is a first-in-class dual-target agonist. This study is a multicenter, randomized, double-blind, double-dummy phase III clinical study being conducetd to evaluate the efficacy and safety of MT1013 compared with active control cinacalcet in secondary hyperparathyroidism patients on maintenance dialysis. Subjects will be 1:1 randomized to receive MT1013 or cinacalcet for 26 weeks. Evaluations of iPTH, Ca, P, BMD, and biomarkers will be done across the study period, to compare efficacy and safety of MT1013 to cinacalcet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MT1013 | Experimental | MT1013 is administered intravenously (IV) for 26 weeks; Dummy cinacalcet will be administered orally for 26 weeks. |
|
| Cinacalcet | Active Comparator | Cinacalcet is administered orally for 26 weeks. Dummy MT1013 is administered intravenously (IV) for 26 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MT1013 | Drug | MT1013 + dummy cinacalcet |
| |
| Cinacalcet |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants with > 50% reduction from baseline in mean intact parathyroid (iPTH) | EAP(Week 22-27) | |
| Percentage of participants with > 30% reduction from baseline in mean iPTH | EAP(Week 22-27) |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Bone Mineral Density | Week 27 | |
| Change from baseline in serum calcium | EAP(Week 22-27) | |
| Change From Baseline in serum phosphorus |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaoqiang Ding, MD | Contact | 021-31587862 | DING.XIAOQIANG@ZS-HOSPITAL.SH.CN |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
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| ID | Term |
|---|---|
| D006962 | Hyperparathyroidism, Secondary |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D051437 | Renal Insufficiency |
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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 |
Cinacalcet + dummy MT1013 |
|
| EAP(Week 22-27) |
| Safety and Tolerance | Incidence and severity of TEAE/TESAE | Up to Week 30 |
| D007674 |
| Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |