The Efficacy and Tolerance of Tacrolimus Sustained-release Capsules on Refractory Nephrotic Syndrome (RNS)

• Status: Completed
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sun Yat-sen University
• Treatments: Tacrolimus

Criteria

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