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

NCT00935389 | Completed

• 1 other identifier: NJCT-0903
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 2

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.

Conditions

Lupus Nephritis; Proteinuria; CTX

Outcome Measures

Primary Outcomes (1)

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

  48 months

Study Arms (1)

immunosuppressor

EXPERIMENTAL

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

Drug: tripterygium glycosides

Interventions

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.

Also known as: TW

immunosuppressor

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nanjing University School of Medicine: lead

Study Sites (2)

Research Institute of Nephrology, Jinling Hospital

Nanjing, Jiangsu, 210002, China

Location

Research Institute of Nephrology,Jinling Hospital

Nanjing, Jiangsu, 210002, China

Location

MeSH Terms

Conditions

Lupus Nephritis; Proteinuria

Condition Hierarchy (Ancestors)

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

Study Officials

• Hu Weixin, Doctor

  Jinling Hospital, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 8, 2009
• First Posted: July 9, 2009
• Study Start: April 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: May 1, 2011
• Last Updated: August 2, 2011

Record last verified: 2009-07

Locations

CN (2)