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

August 1, 2011 updated by: Nanjing University School of Medicine

Prospective Control 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: immunosuppressor
TW 30mg,q.d.*3 months and reduced into 20mg b.i.d
Drug: tripterygium 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.
Other Names:
  • TW

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To analyze the clinical effects of tripterygium glycosides (TW) in LN-V patients with gross proteinuria.
Time Frame: 48 months
48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing University School of Medicine

Investigators

  • Principal Investigator: Hu Weixin, Doctor, Jinling Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

July 8, 2009

First Submitted That Met QC Criteria

July 8, 2009

First Posted (Estimate)

July 9, 2009

Study Record Updates

Last Update Posted (Estimate)

August 2, 2011

Last Update Submitted That Met QC Criteria

August 1, 2011

Last Verified

July 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NJCT-0903

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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