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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Lupus Nephritis Autoimmune Diseases CTX Connective Tissue Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Immune System Diseases Kidney Diseases Lupus Erythematosus, Systemic Male Urogenital Diseases Nephritis Pathological Conditions, Signs and Symptoms Proteinuria Signs and Symptoms Skin and Connective Tissue Diseases Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Research Institute of Nephrology, Jinling Hospital, Nanjing, Jiangsu, China

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

SLE patients aging 18-60 years, all of whom comply to the ISN/RPS classification.
Urine protein≥3.0g/24h, Alb<30g/L and Scr<1.5mg/dL.
All cases are type IV, confirmed by renal biopsy.
All patients sign the informed consent and be willing to follow-up on time

Exclusion criteria

Accepted drug therapy, such as CTX MMF CsA FK506 or TW more than 2 weeks in the latest 3 months.
Scr level above 1.5mg/dL, lasts more than 3 months.
Heart, lung or central nervous systems involved or combined with severe infection.
With liver function abnormal, ALT or AST being two times above the normal.
Pregnant women or patients still in lactation.

Treatment and study plan

tripterygium glycosides

Drug

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.

Other names: TW

Primary outcomes

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

Time frame: 48 months

Sponsors and collaborators

Lead sponsor

Nanjing University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: Jul 9, 2009
Registry last updated: Aug 2, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed