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This a pilot study to evaluate the efficacy and safety of Tacrolimus Sustained-release Capsules (ADVAGRAF) treatment for the induction therapy of refractory lupus nephritis (LN).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADVAGRAF | Experimental | Tacrolimus Sustained-release Capsules (ADVAGRAF) treatment in induction phase |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tacrolimus Sustained-release Capsules (ADVAGRAF) | Drug | Started: 0.05-0.1mg/kg/d, one time per day, the blood level 5-10ng/ml in the induction treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Remission rate (complete or partial remission) | 6 months after therapy |
| Measure | Description | Time Frame |
|---|---|---|
| The changes of proteinuria | every 3 months up to 6 months | |
| SLEDAI scores | SLEDAI:Systemic Lupus Erythematosus Disease Activity Index (Bombardier et al, 1992). | every 3 months up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yu Xueqing, MD | Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Sun Yat-sen University IRB | 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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| Number of participants with adverse events as a measure of safety and tolerability | Adverse events, including infections, transient increases in serum creatinine, gastrointestinal complaints, liver function disorder and glucose intolerance, etc. | every 3 months up to 6 months |
| The changes of renal function | every 3 months up to 6 months |
| Relapse | every 3 months up to 6 months |
| 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 |