To Compare the Efficacy and Safety of Tripterygium (TW) Versus AZA in the Maintenance Therapy for Lupus Nephritis
This study has been completed.
Sponsor:
Nanjing University School of Medicine
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
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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:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
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 May 16, 2013