Nephrotic Syndrome
Conditions
Keywords
Refractory Nephrotic Syndrome, Tacrolimus
Brief 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).
Interventions
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 .
Sponsors
Sun Yat-sen University
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Remission rate (complete or partial remission) at 6 months | 6 months after therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| relapse rate | every 3 months up to 6 months | — |
| side effects | every 3 months up to 6 months | infections, transient increases in serum creatinine, gastrointestinal complaints, liver function disorder and glucose intolerance , etc |
Countries
China
Outcome results
None listed