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

Not Applicable

Completed

• Conditions: Lupus Nephritis
• Interventions: Drug: Tripterygium

• Registration Number: NCT00881309
• Lead Sponsor: Nanjing University School of Medicine

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.

Study Timeline

• Study Start: 2009-03
• Status Verified: 2009-04
• Study First Submitted: 2009-04-14
• Study First Submitted QC: 2009-04-14
• Study First Posted: 2009-04-15
• Primary Completion: 2011-04
• Study Completion: 2011-05
• Last Update Submitted: 2011-05-17
• Last Update Posted: 2011-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
immunosuppressor	Tripterygium	-

Primary Outcome Measures

Name	Time	Method
complete remission rate	2 years

Secondary Outcome Measures

Name	Time	Method
partial remission	2 years
renal relapse	2 years

Trial Locations

Locations (1)

Research Institute of Nephrology,Jinling Hospital; 🇨🇳 Nanjing, Jiangsu, China