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CompletedNCT00935389Updated Aug 2, 2011

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

An interventional study of tripterygium glycosides in Lupus Nephritis, Proteinuria and CTX, sponsored by Nanjing University School of Medicine. Completed at 2 sites in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2011-08-02.

Sponsored by Nanjing University School of Medicine · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Lupus Nephritis
  • Proteinuria
  • CTX
03

In context

Nephritis

245 studies on the registry are indexed under Nephritis; 56 are open to participants now.

This study's enrollment of 44 is below the median of 49 across 156 interventional studies indexed under Nephritis.

Browse Nephritis studies →

Lead sponsor

Nanjing University School of Medicine is the lead sponsor of 37 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
44 participants (actual)

Study arms

  • Experimental
    immunosuppressor

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

    Drug: tripterygium glycosides

Interventions

  • Drugtripterygium glycosides

    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

06

What researchers measure

Primary outcomes

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

    Time frame: 48 months

07

Study locations

2 sites
  • Research Institute of Nephrology, Jinling Hospital
    Nanjing, Jiangsu 210002, China
  • Research Institute of Nephrology,Jinling Hospital
    Nanjing, Jiangsu 210002, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 2, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00935389
Lead sponsor
Nanjing University School of Medicine
First posted
Jul 9, 2009
Start date
Apr 2009
Primary completion
Apr 2011
Completion
May 2011
Last update
Aug 2, 2011

Study contacts

Hu Weixin, Doctor
principal investigator · Jinling Hospital, China

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2009. You cannot join it, but the record below documents what was studied.

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