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| Name | Class |
|---|---|
| Sinocelltech Ltd. | INDUSTRY |
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This is an open-label randomized controlled trial to evaluate the efficacy and safety of one dose versus two doses of ripertamab in children with frequent relapses or steroid-dependent nephrotic syndrome (FRNS/SDNS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Two doses group | Experimental | 2 doses of 375mg/m2 BSA ripertamab at 1-week intervals( within ±1days). |
|
| One dose group | Active Comparator | 1 dose of 375mg/m2 BSA ripertamab. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ripertamab | Drug | 2 doses of 375mg/m2 BSA ripertamab at 1-week intervals( within ±1days). At the meantime, prednisone is administered at a dose of 1.5 mg/kg/d (maximum 40 mg) on alternate days or at the dose being used every alternate day before randomization. After 2 weeks, the dose is reduced by 0.25 mg/kg every 2 weeks, and the drug is discontinued at 3 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse free survival rate | Relapse free survival rate at 1 year | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence frequency at 6 and 12 months | Recurrence frequency within 6 months during the study period. Recurrence frequency within 12 months during the study period. | 1 year |
| Cumulative corticosteroid dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianhua Mao, MD | Contact | 13516819071 | maojh88@zju.edu.cn | |
| Xuan Gang, MD | Contact | 15168358586 | gangxuan90@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang Province 310052 | Hangzhou | Zhejiang | China |
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| ripertamab | Drug | 1 dose of 375mg/m2 BSA ripertamab. At the meantime, prednisone is administered at a dose of 1.5 mg/kg/d (maximum 40 mg) on alternate days or at the dose being used every alternate day before randomization. After 2 weeks, the dose is reduced by 0.25 mg/kg every 2 weeks, and the drug is discontinued at 3 months. |
|
Total amount of corticosteroids used in 1 year during the study period
| 1 year |
| Median recurrence-free survival | From admission day to 18 months | 18 months |
| B-cell count | 18 months |
| The occurrence and severity of adverse events | 18 months |