The Efficacy and Tolerance of Tacrolimus Sustained-release Capsules on Refractory Nephrotic Syndrome (RNS)
NCT ID: NCT01309477
Last Updated: 2011-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
20 participants
INTERVENTIONAL
2011-01-31
2011-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ADVAGRAF
All subjects in the study will take the Tacrolimus Sustained-release Capsules (ADVAGRAF) orally at the basis of low dose prednisone treatment
Tacrolimus Sustained-release Capsules (ADVAGRAF)
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 .
Interventions
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Tacrolimus Sustained-release Capsules (ADVAGRAF)
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 .
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
14 Years
60 Years
ALL
No
Sponsors
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Sun Yat-sen University
OTHER
Responsible Party
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Sun Yat-sen University
Principal Investigators
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Yu Xueqing, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
Locations
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The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Other Identifiers
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SYSU-PRGNS-002
Identifier Type: -
Identifier Source: org_study_id