Prospective, Randomized, Multicenter, Control Study to Assess the Efficacy and Safety of Tacrolimus in Induction and Maintenance Phase Treatment in 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 first randomization with a histologic diagnosis (ISN/RPS 2003 classification of LN) class III, IV, V;
• Class IV LN: proteinuria >1g/24hr or Scr>115umol/L;
• Class III or V LN: proteinuria >2g/24hr or Scr>115umol/L;
• Provision of written informed consent by subject or guardian.

Exclusion criteria

• Inability or unwillingness to provide written informed consent ;
• Known hypersensitivity or contraindication to tacrolimus, cyclophosphamide , azathioprine, corticosteroids;
• Usage of immunosuppression therapy (MMF, CTX, CysA, MTX ect) for more than 1 week within 1 month prior to first randomization;
• Pregnancy, nursing or use of a non-reliable method of contraception;
• Continuous dialysis starting more than 2 weeks before randomization into the induction phase and/or continuous dialysis with an anticipated duration of more than 8 weeks;
• Previous kidney transplant or planted transplant;
• Scr > 4mg/dl (353umol/L);
• Active hepatitis, with liver dysfunction;
• Diagnosed DM;
• Participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening .