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

Lupus Nephritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00881309
• Other study ID #: NJCT-0902
• Status: Completed
• Phase: N/A
• First received: April 14, 2009
• Last updated: May 17, 2011
• Start date: March 2009
• Est. completion date: May 2011

Study information

• Verified date: April 2009
• Source: Nanjing University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: May 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 ?, ?,?+?, ?+? or ? 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

Drug:
• Tripterygium
TW 90mg/d

Locations

Country	Name	City	State
China	Research Institute of Nephrology,Jinling Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete remission rate		2 years	Yes
Secondary	renal relapse		2 years	Yes
Secondary	partial remission		2 years	Yes