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Prospective Study of TW in the Treatment of LN Type V With Gross Proteinuria

Not Applicable
Completed
Conditions
Lupus Nephritis
Proteinuria
CTX
Interventions
Registration Number
NCT00935389
Lead Sponsor
Nanjing University School of Medicine
Brief Summary

The purpose of this study is to analyze the clinical effects and adverse reactions of tripterygium glycosides (TW) and CTX in LN-V patients with gross proteinuria.

Detailed Description

Compared with cyclophosphamide(CTX), to analyze the clinical effects and adverse reactions of tripterygium glycosides (TW) in LN-V patients with gross proteinuria.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
44
Inclusion Criteria
  1. SLE patients aging 18-60 years, all of whom comply to the ISN/RPS classification.
  2. Urine protein≥3.0g/24h, Alb<30g/L and Scr<1.5mg/dL.
  3. All cases are type IV, confirmed by renal biopsy.
  4. All patients sign the informed consent and be willing to follow-up on time
Exclusion Criteria
  1. Accepted drug therapy, such as CTX MMF CsA FK506 or TW more than 2 weeks in the latest 3 months.
  2. Scr level above 1.5mg/dL, lasts more than 3 months.
  3. Heart, lung or central nervous systems involved or combined with severe infection.
  4. With liver function abnormal, ALT or AST being two times above the normal.
  5. Pregnant women or patients still in lactation.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
immunosuppressortripterygium glycosidesTW 30mg,q.d.\*3 months and reduced into 20mg b.i.d
Primary Outcome Measures
NameTimeMethod
To analyze the clinical effects of tripterygium glycosides (TW) in LN-V patients with gross proteinuria.48 months
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (2)

Research Institute of Nephrology, Jinling Hospital

🇨🇳

Nanjing, Jiangsu, China

Research Institute of Nephrology,Jinling Hospital

🇨🇳

Nanjing, Jiangsu, China

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