Trial | NCT00615667  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    tacrolimus ...

  • Study Participants

    61
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.
Study Started
Jun 30
2006
Primary Completion
Sep 30
2008
Study Completion
Sep 30
2008
Last Update
Apr 20
2016
Estimate

Drug tacrolimus (FK506)

Started: 0.05-0.1mg/kg/d,divided into two daily dose at 12hr; the blood level:5-10ng/ml in induction phase;and 4-6ng/ml in maintenance phase;

tacrolimus(fk506) treatment Experimental

tacrolimus(fk506) treatment

Criteria 

Inclusion Criteria:

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 Criteria:

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 .
No Results Posted