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

Study Overview
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Brief Summary
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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).

Conditions
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Nephrotic Syndrome

Intervention / Treatment
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* Drug: Tacrolimus Sustained-release Capsules (ADVAGRAF)


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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ADVAGRAF<br>All subjects in the study will take the Tacrolimus Sustained-release Capsules (ADVAGRAF) orally at the basis of low dose prednisone treatment | Drug: Tacrolimus Sustained-release Capsules (ADVAGRAF)<br>* Started: 0.05-0.1mg/kg/d, one time per day, then adjusting the dose to maintain the blood level 5-10ng/ml in the induction treatment .<br>* Other names: ADVAGRAF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission rate (complete or partial remission) at 6 months |  | 6 months after therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relapse rate |  | every 3 months up to 6 months | 
| side effects | infections, transient increases in serum creatinine, gastrointestinal complaints, liver function disorder and glucose intolerance , etc | every 3 months up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Refractory Nephrotic Syndrome, Tacrolimus