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To Compare the Efficacy and Safety of Tripterygium (TW) Versus AZA in the Maintenance Therapy for Lupus Nephritis

Primary Purpose

Lupus Nephritis

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Tripterygium
Sponsored by
Nanjing University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lupus Nephritis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients who signed written informed consent form;
  2. SLE patient, aged between 18-60 years, female or male;
  3. Patients diagnosed lupus nephritis according to ISN/RPS 2003 classification criteria, class Ⅲ, Ⅳ,Ⅳ+Ⅴ, Ⅲ+Ⅴ or Ⅴ LN by renal biopsy;
  4. All patients received induction therapy for 6-12 months, including MMF, CTX, FK506 or multi-target therapy;

  5. When recruited in the study, patients received partial remission or complete remission for 3 months;

    • Complete remission: proteinuria < 0.4 g/24h, negative urine sediment, serum albumin > 35 g/L, elevated scr < 0.3 mg/dl, no extra-renal complications;
    • Partial remission: proteinuria < 1.0 g/24h, urine RBC < 500000/ml without casts, serum albumin > 35 g/L, elevated scr <0.3 mg/dl, no extra-renal complications.

Exclusion Criteria:

  1. Patients who didn't sign written informed consent form or could not obey the protocol;
  2. Patients who didn't received the CR or PR criterion;
  3. Patients who have impaired liver function, with ALT/GPT or AST/GOT twice more than the normal upper limit;
  4. WBC < 3000/mm3 in peripheral blood;
  5. Patients with abnormal of central nervous system.

Sites / Locations

  • Research Institute of Nephrology,Jinling Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

immunosuppressor

Arm Description

Outcomes

Primary Outcome Measures

complete remission rate

Secondary Outcome Measures

renal relapse
partial remission

Full Information

First Posted
April 14, 2009
Last Updated
May 17, 2011
Sponsor
Nanjing University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00881309
Brief Title
To Compare the Efficacy and Safety of Tripterygium (TW) Versus AZA in the Maintenance Therapy for Lupus Nephritis
Official Title
To Compare the Efficacy and Safety of Tripterygium (TW) vs Aza in the Maintenance Therapy for Lupus Nephritis
Study Type
Interventional

2. Study Status

Record Verification Date
April 2009
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nanjing University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to: To access the efficacy of TW compared to Aza in the maintenance therapy for lupus nephritis To investigate the safety and tolerability of TW versus Aza in the maintenance therapy for lupus nephritis
Detailed Description
Tripterygium (TW) is a Chinese traditional patent drugs in treating chronic glomerulonephritis. It has been used to treat lupus nephritis for many years with less side effects. We compare the efficacy and safety of TW vs Aza in the maintenance therapy of lupus nephritis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Nephritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
immunosuppressor
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Tripterygium
Intervention Description
TW 90mg/d
Primary Outcome Measure Information:
Title
complete remission rate
Time Frame
2 years
Secondary Outcome Measure Information:
Title
renal relapse
Time Frame
2 years
Title
partial remission
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who signed written informed consent form; SLE patient, aged between 18-60 years, female or male; Patients diagnosed lupus nephritis according to ISN/RPS 2003 classification criteria, class Ⅲ, Ⅳ,Ⅳ+Ⅴ, Ⅲ+Ⅴ or Ⅴ LN by renal biopsy; All patients received induction therapy for 6-12 months, including MMF, CTX, FK506 or multi-target therapy; When recruited in the study, patients received partial remission or complete remission for 3 months; Complete remission: proteinuria < 0.4 g/24h, negative urine sediment, serum albumin > 35 g/L, elevated scr < 0.3 mg/dl, no extra-renal complications; Partial remission: proteinuria < 1.0 g/24h, urine RBC < 500000/ml without casts, serum albumin > 35 g/L, elevated scr <0.3 mg/dl, no extra-renal complications. Exclusion Criteria: Patients who didn't sign written informed consent form or could not obey the protocol; Patients who didn't received the CR or PR criterion; Patients who have impaired liver function, with ALT/GPT or AST/GOT twice more than the normal upper limit; WBC < 3000/mm3 in peripheral blood; Patients with abnormal of central nervous system.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weixin Hu, Doctor
Organizational Affiliation
Nanjing University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Institute of Nephrology,Jinling Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China

12. IPD Sharing Statement

Learn more about this trial

To Compare the Efficacy and Safety of Tripterygium (TW) Versus AZA in the Maintenance Therapy for Lupus Nephritis

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