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

Nanjing University School of Medicine

Status: Completed

Conditions: CTX; Proteinuria; Lupus Nephritis

Treatments: Drug: tripterygium glycosides

Study type: Interventional

Funder types: Other

Identifiers

NCT00935389

NJCT-0903

Details and patient eligibility

About

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.

Full description

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

Enrollment: 44 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 1 patient group

immunosuppressor

Experimental group

Description:

TW 30mg,q.d.\*3 months and reduced into 20mg b.i.d

Treatment:

Drug: tripterygium glycosides