Efficacy and Safety of Tacrolimus Sustained-release Capsules in Induction Phase Treatment in Lupus Nephritis

Inclusion Criteria: 1. Subjects of either sex, 14-65 years of age; 2. Diagnosis of systemic lupus erythematosus (SLE) according to the albumin-creatinine ratio (ACR) criteria (1997); 3. Kidney biopsy within the 6 months prior to study with a histologic diagnosis (ISN/RPS 2003 classification of LN) class V, III +V, IV+V; 4. LN (Class IV+V): proteinuria \> 1g/24hr or Scr \> 1.3 mg/dl or active urinary sediment (erythrocyte cast, \> 5 white blood cell count (WBC) /high power field (hpf)(excluding infection ), \> 5 red blood cell count (RBC)/hpf; 5. LN (Class V or III +V ): proteinuria \> 2g/24hr or Scr \> 1.3 mg/dl; 6. Provision of written informed consent by subject or guardian Exclusion Criteria: 1. Inability or unwillingness to provide written informed consent 2. Usage of immunosuppression therapy (MMF, Cyclophosphamide (CTX), Cyclosporine A (CysA), methotrexate (MTX) ect) for more than 1 week within 1 month or Pulse intravenous MP treatment prior to recruitment 3. Scr \> 4mg/dl (354umol/L) 4. Needing pulse intravenous Methylprednisolone (MP) or intravenous immunoglobulin 5. Lupus encephalopathy 6. Diagnosed diabetes mellitus (DM); Malignant tumors (except fully cured basal cell carcinoma) 7. History of significant gastrointestinal disorders (e.g. severe chronic diarrhea or active peptic ulcer disease) within 3 month prior to enter this study 8. Any Active systemic infection or history of serious infection within one month of entry 9. known infection with HIV, hepatitis B, or hepatitis C 10. Known hypersensitivity or contraindication to tacrolimus, corticosteroids 11. Participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening 12. Pregnancy, nursing or use of a non-reliable method of contraception.