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

Inclusion criteria

• Subjects of either sex, 14-65 years of age;
• Diagnosis of SLE according to the ACR criteria (1997);
• Kidney biopsy within the 6 months prior to study with a histologic diagnosis (ISN/RPS 2003 classification of LN) class IV, V, V+ III, V+ IV;
• Usage of intravenous pulse cyclophosphamide for more than 3 times or immunosuppression therapy (AZA, MMF, oral cyclophosphamide, ect) for more than 6 months;
• proteinuria > 1g/24hr or Scr > 1.3 mg/dl or active urinary sediment (erythrocyte cast, > 5 WBC/high power field (hpf) (excluding infection), > 5 RBC/hpf);
• Provision of written informed consent by subject or guardian

Exclusion criteria

• Inability or unwillingness to provide written informed consent ;
• Usage of immunosuppression therapy (MMF, CTX, CysA, MTX etc) for more than 1 week within 1 month or intravenous MP Pulse treatment prior to entry;
• Scr > 4mg/dl (354umol/L);
• Needing pulse intravenous MP or intravenous immunoglobulin;
• Lupus encephalopathy;
• Diagnosed DM; Malignant tumors (except fully cured basal cell carcinoma);
• History of significant gastrointestinal disorders (e.g. active peptic ulcer disease or pancreatitis) within 3 month prior to enter this study;
• Known hypersensitivity or contraindication to tacrolimus, corticosteroids
• Any Active systemic infection or history of serious infection within one month of entry or known infection with HIV, hepatitis B, or hepatitis C;
• Participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening;
• Pregnancy, nursing or use of a non-reliable method of contraception.