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

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

Study Overview

• Status: Completed
• Conditions: Lupus Nephritis
• Intervention / Treatment: Drug: Tripterygium

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 Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210002
      • Research Institute of Nephrology,Jinling Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: immunosuppressor	Drug: Tripterygium; TW 90mg/d

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
complete remission rate	2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
renal relapse	2 years
partial remission	2 years

Collaborators and Investigators

• Sponsor: Nanjing University School of Medicine
• Investigators: Principal Investigator: Weixin Hu, Doctor, Nanjing University School of Medicine

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): May 1, 2011

Study Registration Dates

• First Submitted: April 14, 2009
• First Submitted That Met QC Criteria: April 14, 2009
• First Posted (Estimate): April 15, 2009

Study Record Updates

• Last Update Posted (Estimate): May 18, 2011
• Last Update Submitted That Met QC Criteria: May 17, 2011
• Last Verified: April 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Kidney Diseases; Urologic Diseases; Connective Tissue Diseases; Glomerulonephritis; Lupus Erythematosus, Systemic; Nephritis; Lupus Nephritis
• Other Study ID Numbers: NJCT-0902