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Due to safety concern of active control drug
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| Name | Class |
|---|---|
| Astellas Pharma China, Inc. | INDUSTRY |
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The purpose of this study is to compare the efficacy and safety of tacrolimus capsules with leflunomide tablets in the treatment of lupus nephritis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tacrolimus group | Experimental | tacrolimus capsule + leflunomide placebo |
|
| leflunomide group | Active Comparator | tacrolimus placebo + leflunomide tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tacrolimus capsule | Drug | oral |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| remission rate (partial remission + complete remission) | at 6 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| urinary protein excretion for 24 hrs (24hr proteinuria) | at 12 weeks and 24 weeks | |
| serum albumin level | at 12 weeks and 24 weeks | |
| serum creatinine level |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Use Central Contact | Astellas Pharma Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing | China | |||||
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| tacrolimus placebo | Drug | oral |
|
| leflunomide tablet | Drug | oral |
|
|
| leflunomide placebo | Drug | oral |
|
| prednisone | Drug | oral |
|
| at 12 weeks and 24 weeks |
| estimated glomerular filtration rate (eGFR) | at 12 weeks and 24 weeks |
| Fujian |
| China |
| Hubei | China |
| Hunan | China |
| Jiangsu | China |
| Jilin City | China |
| Liaoning | China |
| Shandong | China |
| Shanghai | China |
| Shanxi | China |
| Sichuan | China |
| Zhejiang | China |
| ID | Term |
|---|---|
| D008181 | Lupus Nephritis |
| D009393 | Nephritis |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008180 | Lupus Erythematosus, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| D000077339 | Leflunomide |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D007555 | Isoxazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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