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

Nanjing University School of Medicine44 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Lupus Nephritis Proteinuria CTX

Interventions

tripterygium glycosidesDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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.

Locations (2)

Research Institute of Nephrology, Jinling Hospital

Nanjing, Jiangsu, China

Research Institute of Nephrology,Jinling Hospital

Nanjing, Jiangsu, China

Outcomes

Primary Outcomes

To analyze the clinical effects of tripterygium glycosides (TW) in LN-V patients with gross proteinuria.

Time frame: 48 months

Data from ClinicalTrials.gov

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