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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00881309

Enrollment

Registered

2009-04-15

Start date

2009-03-31

Completion date

2011-05-31

Last updated

2011-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lupus Nephritis

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.

Interventions

DRUGTripterygium

TW 90mg/d

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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.

Design outcomes

Primary

Measure	Time frame
complete remission rate	2 years

Secondary

Measure	Time frame
renal relapse	2 years
partial remission	2 years

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026