The Efficacy and Tolerance of Tacrolimus Sustained-release Capsules on Refractory Nephrotic Syndrome (RNS)

Nephrotic Syndrome Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01309477
• Other study ID #: SYSU-PRGNS-002
• Status: Completed
• Phase: Phase 3
• First received: February 1, 2011
• Last updated: November 1, 2011
• Start date: January 2011
• Est. completion date: October 2011

Study information

• Verified date: October 2011
• 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

It is a pilot study to explore the efficacy and safety of Tacrolimus Sustained-release Capsules (ADVAGRAF) on 6-month induction therapy of Refractory Nephrotic Syndrome (RNS).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 60 Years

Eligibility

Inclusion Criteria:

• Subjects of either sex, 14-60 years of age

• Diagnosis of Nephrotic syndrome with hypoalbuminemia (< 3.0g/dl) and heavy proteinuria (> 3.5g/24hr) and exclude secondary Nephrotic syndrome

• Refractory Nephrotic Syndrome

1. Steroid resistant: failure to respond (either complete or partial remission) after a course of 8 weeks of 1.0 mg/kg/d prednisone or equal dose of steroid therapy

2. Steroid dependent: recurrence of nephrotic proteinuria during tapering of prednisone at a dose > 10 mg/day or within the first 2 weeks after withdrawal of prednisone

3. Frequently recurrence: initial remission with steroid induction therapy, but relapsed 2 or more in 6 months or 3 or more within 12 months

4. Failure to respond (either complete or partial remission) even after CTX, MMF or CsA therapy combined with steroid

• eGFR = 60 ml/min/1.73 m2

• Provision of written informed consent by subject or guardian

Exclusion Criteria:

• Systemic disease

• eGFR < 60ml/min/1.73m2

• Diagnosed DM

• Malignant tumors (except fully cured basal cell carcinoma)

• Familial nephritic syndrome

• History of significant gastrointestinal disorders (e.g. severe chronic diarrhea or active peptic ulcer disease) within 3 month prior to enter this study

• Any Active systemic infection or history of serious infection within one month of entry or known infection with HIV, hepatitis B, or hepatitis C

• Known hypersensitivity or contraindication to tacrolimus, corticosteroids

• Participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening

• Pregnancy, nursing or use of a non-reliable method of contraception

• Inability or unwillingness to provide written informed consent

• Usage of immunosuppression therapy (MMF, CTX, CysA, MTX ect) for more than 1 week within 1 month prior to first randomization or intravenous MP Pulse treatment

Study Design

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

Related Conditions & MeSH terms

• Nephrosis
• Nephrotic Syndrome

Intervention

Drug:
• Tacrolimus Sustained-release Capsules (ADVAGRAF)
Started: 0.05-0.1mg/kg/d, one time per day, then adjusting the dose to maintain the blood level 5-10ng/ml in the induction treatment .

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission rate (complete or partial remission) at 6 months		6 months after therapy	Yes
Secondary	relapse rate		every 3 months up to 6 months	Yes
Secondary	side effects	infections, transient increases in serum creatinine, gastrointestinal complaints, liver function disorder and glucose intolerance , etc	every 3 months up to 6 months	Yes