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

This study has been completed.
Sponsor:
Information provided by:
Nanjing University School of Medicine
ClinicalTrials.gov Identifier:
NCT00881309
First received: April 14, 2009
Last updated: May 17, 2011
Last verified: April 2009
  Purpose

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

Condition Intervention
Lupus Nephritis
Drug: Tripterygium

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: To Compare the Efficacy and Safety of Tripterygium (TW) vs Aza in the Maintenance Therapy for Lupus Nephritis

Further study details as provided by Nanjing University School of Medicine:

Primary Outcome Measures:
  • complete remission rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • renal relapse [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • partial remission [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Enrollment: 94
Study Start Date: March 2009
Study Completion Date: May 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: immunosuppressor Drug: Tripterygium
TW 90mg/d
Other Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00881309

Locations
China, Jiangsu
Research Institute of Nephrology,Jinling Hospital
Nanjing, Jiangsu, China, 210002
Sponsors and Collaborators
Nanjing University School of Medicine
Investigators
Principal Investigator: Weixin Hu, Doctor Nanjing University School of Medicine
  More Information

No publications provided

Responsible Party: Weixin Hu, Nanjing University School of Medicine
ClinicalTrials.gov Identifier: NCT00881309     History of Changes
Other Study ID Numbers: NJCT-0902
Study First Received: April 14, 2009
Last Updated: May 17, 2011
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Lupus Nephritis
Nephritis
Glomerulonephritis
Kidney Diseases
Urologic Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on July 26, 2014