Prospective, Multicenter Study of the Efficacy and Tolerance of Tacrolimus on Refractory Nephrotic Syndrome (RNS)

Inclusion criteria

• Subjects of either sex, 14-65 years of age;
• Diagnosis of Nephrotic syndrome with hypoalbuminemia (<3.0g/dl) and heavy proteinuria (> 3.5g/24hr);
• Provision of written informed consent by subject or guardian;
• Refractory nephrotic syndrome:

Steroid resistant: Persistence of proteinuria despite prednisone therapy 1mg/kg/d for 16 weeks; Steroid dependent: NS recurs when steroid dosage decease.Twice within 6 months, and 3 times within 1 year.

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 .