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This study is a multicenter, randomized, open label, cyclosporine controlled Phase II trial aimed at evaluating the efficacy, safety, pharmacokinetics, and immunogenicity of Zuberitamab in patients with primary membranous nephropathy, and exploring the Phase III dosing regimen, sample size, and endpoint evaluation time
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zuberitamab 600mg | Experimental |
| |
| Zuberitamab 1000mg | Experimental |
| |
| cyclosporine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zuberitamab 600mg | Drug | administered twice with a 2-week interval between each dose (i.e. D1, D15). One treatment cycle is 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of subjects who achieved overall response (OR) in the urinary protein/creatinine ratio (UPCR) at week 76 | The proportion of subjects who achieved overall response (OR) in the urinary protein/creatinine ratio (UPCR) at week 76 | Week 76 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital Fudan University | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| Zuberitamab 1000mg | Drug | administered twice with a 2-week interval between each dose (i.e. D1, D15). One treatment cycle is 24 weeks |
|
| cyclosporine | Drug | Initial dose of 3.5 mg/kg/d, oral administration, divided into two doses, taken 12 hours apart (Q12h) |
|
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |