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

Phase 3

Completed

• Conditions: Nephrotic Syndrome
• Interventions: Drug: Tacrolimus Sustained-release Capsules (ADVAGRAF)

• Registration Number: NCT01309477
• Lead Sponsor: Sun Yat-sen University

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-02-01
• Study First Submitted QC: 2011-03-04
• Study First Posted: 2011-03-07
• Status Verified: 2011-10
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Last Update Submitted: 2011-11-01
• Last Update Posted: 2011-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ADVAGRAF	Tacrolimus Sustained-release Capsules (ADVAGRAF)	All subjects in the study will take the Tacrolimus Sustained-release Capsules (ADVAGRAF) orally at the basis of low dose prednisone treatment

Primary Outcome Measures

Name	Time	Method
Remission rate (complete or partial remission) at 6 months	6 months after therapy

Secondary Outcome Measures

Name	Time	Method
relapse rate	every 3 months up to 6 months
side effects	every 3 months up to 6 months	infections, transient increases in serum creatinine, gastrointestinal complaints, liver function disorder and glucose intolerance , etc

Trial Locations

Locations (1)

The First Affiliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China