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

Kidney Diseases Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00615667
• Other study ID #: SYSU-PRGNS-001
• Status: Completed
• Phase: Phase 3
• First received: February 1, 2008
• Last updated: April 19, 2016
• Start date: June 2006
• Est. completion date: September 2008

Study information

• 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

Clinical Trial 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.

Recruitment information / eligibility

• 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 .

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Kidney Diseases
• Nephrosis
• Nephrotic Syndrome
• Tacrolimus

Intervention

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;

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission rate		2006-2008	Yes
Secondary	Renal function, proteinuria, relapse		2006-2008	Yes