The Efficacy and Tolerance of Tacrolimus Sustained-release Capsules on Refractory Nephrotic Syndrome (RNS)
The Efficacy and Tolerance of Tacrolimus Sustained-release Capsules on Refractory Nephrotic Syndrome (RNS)
It is a pilot study to explore the efficacy and safety of Tacrolimus Sustained-release
 Capsules (ADVAGRAF) on 6-month induction therapy of Refractory Nephrotic Syndrome (RNS).
Inclusion Criteria:

 -  Subjects of either sex, 14-60 years of age

 -  Diagnosis of Nephrotic syndrome with hypoalbuminemia (< 3.0g/dl) and heavy proteinuria
 (> 3.5g/24hr) and exclude secondary Nephrotic syndrome

 -  Refractory Nephrotic Syndrome

 1. Steroid resistant: failure to respond (either complete or partial remission)
 after a course of 8 weeks of 1.0 mg/kg/d prednisone or equal dose of steroid
 therapy

 2. Steroid dependent: recurrence of nephrotic proteinuria during tapering of
 prednisone at a dose > 10 mg/day or within the first 2 weeks after withdrawal of
 prednisone

 3. Frequently recurrence: initial remission with steroid induction therapy, but
 relapsed 2 or more in 6 months or 3 or more within 12 months

 4. Failure to respond (either complete or partial remission) even after CTX, MMF or
 CsA therapy combined with steroid

 -  eGFR ≥ 60 ml/min/1.73 m2

 -  Provision of written informed consent by subject or guardian

 Exclusion Criteria:

 -  Systemic disease

 -  eGFR < 60ml/min/1.73m2

 -  Diagnosed DM

 -  Malignant tumors (except fully cured basal cell carcinoma)

 -  Familial nephritic syndrome

 -  History of significant gastrointestinal disorders (e.g. severe chronic diarrhea or
 active peptic ulcer disease) within 3 month prior to enter this study

 -  Any Active systemic infection or history of serious infection within one month of
 entry or known infection with HIV, hepatitis B, or hepatitis C

 -  Known hypersensitivity or contraindication to tacrolimus, corticosteroids

 -  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

 -  Inability or unwillingness to provide written informed consent

 -  Usage of immunosuppression therapy (MMF, CTX, CysA, MTX ect) for more than 1 week
 within 1 month prior to first randomization or intravenous MP Pulse treatment