Overview

Prospective, Multicenter Study of the Efficacy and Tolerance of Tacrolimus on Refractory Nephrotic Syndrome (RNS)

Status:
Completed

Trial end date:
2008-09-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Sun Yat-sen University

Treatments:

Tacrolimus

Criteria

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 .