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| Name | Class |
|---|---|
| The First People's Hospital of Yunnan | OTHER |
| The First Affiliated Hospital of Nanchang University | OTHER |
| General Hospital of Ningxia Medical University | OTHER |
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This is a multi-center, randomized, double-blind, placebo-controlled study. Study subjects are class III, IV, V, III+V, IV+V lupus nephritis patients, according to ISN/RPS 2003 classification of LN, with active lesion needing corticosteroid in combination with immunosuppressant therapy.
Subjects who meet the eligibility criteria during screening will be randomized to 1 of 3 treatment groups in a 1:1:1 ratio: 25mg bid artesunate, 50mg bid artesunate or placebo plus standard of care (prednisone plus mycophenolate mofetil ï¼»MMFï¼½) for 6 month.
Lupus nephritis (LN) can be observed in up to 70% of SLE patients and is often associated with a poor long-term prognosis. Artesunate, one analogues of antimalarial agent artemisinin, have immunomodulatory properties that might be useful for treating autoimmune diseases including SLE. it is still lack of solid evidence from RCT to evaluate efficacy and safety of artesunate plus standard of care in active LN. Regarding no data could be referred to decide the sample size and optimal dosage, we designed this pilot study. The result and experience of pilot study will answer these questions, and guarantee the multicenter RCT to be conducted successfully.
This is a multi-center, randomized, double-blind, placebo-controlled study. Study subjects are class III, IV, V, III+V, IV+V lupus nephritis patients, according to ISN/RPS 2003 classification of LN, with active lesion needing corticosteroid in combination with immunosuppressant therapy.
Subjects who meet the eligibility criteria during screening will be randomized to 1 of 3 treatment groups in a 1:1:1 ratio: 25mg bid artesunate, 50mg bid artesunate or placebo plus standard of care (prednisone plus mycophenolate mofetil ï¼»MMFï¼½) for 6 month.
All the subjects were asked to visit the hospital for weekly follow-up for four weeks, then monthly thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| low dose Art | Experimental | 25mg bid Artesunate and standard of care was given to patients |
|
| high dose Art | Experimental | 50mg bid Artesunate and standard of care was given to patients |
|
| placebo | Placebo Comparator | Placebo and standard of care was given to patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artesunate | Drug | Artesunate was produced by pharmaceutical factory for research specifically |
|
| Measure | Description | Time Frame |
|---|---|---|
| Remission |
| 6 month |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xueqing Yu, MD, Phd | Contact | 13802793488 | yuxq@mail.sysu.edu.cn | |
| Wei Chen, MD, Phd | Contact | 13924150966 | vvchen66@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The 1st Affiliated Hospital, Sun Yet-sen University | Recruiting | Guangzhou | Guangdong | 510080 | China |
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| ID | Term |
|---|---|
| D008181 | Lupus Nephritis |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D000077332 | Artesunate |
| D027724 | Reproductive Techniques, Assisted |
| ID | Term |
|---|---|
| D037621 | Artemisinins |
| D017382 | Reactive Oxygen Species |
| D005609 | Free Radicals |
| D007287 | Inorganic Chemicals |
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| First Affiliated Hospital of Fujian Medical University |
| OTHER |
| Shenzhen Second People's Hospital | OTHER |
| The Third Xiangya Hospital of Central South University | OTHER |
| Tongji Hospital | OTHER |
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| placebo | Other | placebo was produced by pharmaceutical factory for research specifically |
|
| 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 |
| D009930 |
| Organic Chemicals |
| D012717 | Sesquiterpenes |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D012099 | Reproductive Techniques |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |