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

Primary Purpose

Nephrotic Syndrome

Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Tacrolimus Sustained-release Capsules (ADVAGRAF)
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nephrotic Syndrome focused on measuring Refractory Nephrotic Syndrome, Tacrolimus

Eligibility Criteria

14 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The First Affiliated Hospital of Sun Yat-sen University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ADVAGRAF

Arm Description

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

Outcomes

Primary Outcome Measures

Remission rate (complete or partial remission) at 6 months

Secondary Outcome Measures

relapse rate
side effects
infections, transient increases in serum creatinine, gastrointestinal complaints, liver function disorder and glucose intolerance , etc

Full Information

First Posted
February 1, 2011
Last Updated
November 1, 2011
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT01309477
Brief Title
The Efficacy and Tolerance of Tacrolimus Sustained-release Capsules on Refractory Nephrotic Syndrome (RNS)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nephrotic Syndrome
Keywords
Refractory Nephrotic Syndrome, Tacrolimus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ADVAGRAF
Arm Type
Experimental
Arm Description
All subjects in the study will take the Tacrolimus Sustained-release Capsules (ADVAGRAF) orally at the basis of low dose prednisone treatment
Intervention Type
Drug
Intervention Name(s)
Tacrolimus Sustained-release Capsules (ADVAGRAF)
Other Intervention Name(s)
ADVAGRAF
Intervention Description
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 .
Primary Outcome Measure Information:
Title
Remission rate (complete or partial remission) at 6 months
Time Frame
6 months after therapy
Secondary Outcome Measure Information:
Title
relapse rate
Time Frame
every 3 months up to 6 months
Title
side effects
Description
infections, transient increases in serum creatinine, gastrointestinal complaints, liver function disorder and glucose intolerance , etc
Time Frame
every 3 months up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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 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 Frequently recurrence: initial remission with steroid induction therapy, but relapsed 2 or more in 6 months or 3 or more within 12 months 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu Xueqing, MD
Organizational Affiliation
Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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