Kidney Diseases Clinical Trial
Verified date | April 2016 |
Source | Sun Yat-sen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
Exploring the efficacy and safety of Tacrolimus on refractory nephrotic syndrome ; Acquiring the experience of Tacrolimus on the treatment of refractory nephrotic syndrome in Chinese patients.
Status | Completed |
Enrollment | 61 |
Est. completion date | September 2008 |
Est. primary completion date | September 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 14 Years to 65 Years |
Eligibility |
Inclusion Criteria: 1. Subjects of either sex, 14-65 years of age; 2. Diagnosis of Nephrotic syndrome with hypoalbuminemia (<3.0g/dl) and heavy proteinuria (> 3.5g/24hr); 3. Provision of written informed consent by subject or guardian; 4. Refractory nephrotic syndrome: Steroid resistant: Persistence of proteinuria despite prednisone therapy 1mg/kg/d for 16 weeks; Steroid dependent: NS recurs when steroid dosage decease.Twice within 6 months, and 3 times within 1 year. Exclusion Criteria: 1. Inability or unwillingness to provide written informed consent ; 2. Known hypersensitivity or contraindication to tacrolimus, cyclophosphamide, azathioprine, corticosteroids; 3. Usage of immunosuppression therapy (MMF, CTX, CysA, MTX ect) for more than 1 week within 1 month prior to first randomization; 4. Pregnancy, nursing or use of a non-reliable method of contraception; 5. Continuous dialysis starting more than 2 weeks before randomization into the induction phase and/or continuous dialysis with an anticipated duration of more than 8 weeks; 6. Previous kidney transplant or planted transplant; 7. Scr > 4mg/dl (353umol/L); 8. Active hepatitis, with liver dysfunction; 9. Diagnosed DM; 10. Participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening . |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-sen University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Remission rate | 2006-2008 | Yes | |
Secondary | Renal function, proteinuria, relapse | 2006-2008 | Yes |
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