Status:
COMPLETED
Prospective, Multicenter Study of the Efficacy and Tolerance of Tacrolimus on Refractory Nephrotic Syndrome (RNS)
Lead Sponsor:
Sun Yat-sen University
Conditions:
Kidney Diseases
Nephrotic Syndrome
Eligibility:
All Genders
14-65 years
Phase:
PHASE3
Brief Summary
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.
Eligibility Criteria
Inclusion
- Subjects of either sex, 14-65 years of age;
- Diagnosis of Nephrotic syndrome with hypoalbuminemia (\<3.0g/dl) and heavy proteinuria (\> 3.5g/24hr);
- Provision of written informed consent by subject or guardian;
- 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
- Inability or unwillingness to provide written informed consent ;
- Known hypersensitivity or contraindication to tacrolimus, cyclophosphamide, azathioprine, corticosteroids;
- Usage of immunosuppression therapy (MMF, CTX, CysA, MTX ect) for more than 1 week within 1 month prior to first randomization;
- Pregnancy, nursing or use of a non-reliable method of contraception;
- 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;
- Previous kidney transplant or planted transplant;
- Scr \> 4mg/dl (353umol/L);
- Active hepatitis, with liver dysfunction;
- Diagnosed DM;
- Participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening .
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00615667
Start Date
June 1 2006
End Date
September 1 2008
Last Update
April 20 2016
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