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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00881309
First Posted: April 15, 2009
Last Update Posted: May 18, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Nanjing University School of Medicine
  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
Intervention Model: Parallel Assignment
Masking: None (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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • complete remission rate [ Time Frame: 2 years ]

Secondary Outcome Measures:
  • renal relapse [ Time Frame: 2 years ]
  • partial remission [ Time Frame: 2 years ]

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Weixin Hu, Nanjing University School of Medicine
ClinicalTrials.gov Identifier: NCT00881309     History of Changes
Other Study ID Numbers: NJCT-0902
First Submitted: April 14, 2009
First Posted: April 15, 2009
Last Update Posted: May 18, 2011
Last Verified: April 2009

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