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

NCT00881309 | Completed DMC

• 1 other identifier: NJCT-0902
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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

Conditions

Lupus Nephritis

Outcome Measures

Primary Outcomes (1)

• complete remission rate

  2 years

Secondary Outcomes (2)

• renal relapse

  2 years

• partial remission

  2 years

Study Arms (1)

immunosuppressor

EXPERIMENTAL

Drug: Tripterygium

Interventions

Tripterygium DRUG

TW 90mg/d

immunosuppressor

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing University School of Medicine: lead

Study Sites (1)

Research Institute of Nephrology,Jinling Hospital

Nanjing, Jiangsu, 210002, China

Location

MeSH Terms

Conditions

Lupus Nephritis

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Weixin Hu, Doctor

  Nanjing University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 14, 2009
• First Posted: April 15, 2009
• Study Start: March 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: May 1, 2011
• Last Updated: May 18, 2011

Record last verified: 2009-04

Locations

CN (1)