Status:
COMPLETED
To Compare the Efficacy and Safety of Tripterygium (TW) Versus AZA in the Maintenance Therapy for Lupus Nephritis
Lead Sponsor:
Nanjing University School of Medicine
Conditions:
Lupus Nephritis
Eligibility:
All Genders
18-60 years
Phase:
NA
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 mai...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT00881309
Start Date
March 1 2009
End Date
May 1 2011
Last Update
May 18 2011
Active Locations (1)
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1
Research Institute of Nephrology,Jinling Hospital
Nanjing, Jiangsu, China, 210002