CTX, Lupus Nephritis, Proteinuria
Conditions
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.
Interventions
The onset dosage should be 30mg/q.d. and can be reduced into 20mg b.i.d if CR obtained in 3 months. Without CR in 3 months, the dosage of 90mg/d will last for another 3 months and then reduced to 60mg/d.
Sponsors
Nanjing University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To analyze the clinical effects of tripterygium glycosides (TW) in LN-V patients with gross proteinuria. | 48 months |
Countries
China
Outcome results
None listed