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

Primary Purpose

Lupus Nephritis, Proteinuria, CTX

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
tripterygium glycosides
Sponsored by
Nanjing University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lupus Nephritis

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Research Institute of Nephrology, Jinling Hospital
  • Research Institute of Nephrology,Jinling Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

immunosuppressor

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 8, 2009
Last Updated
August 1, 2011
Sponsor
Nanjing University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT00935389
Brief Title
Prospective Study of TW in the Treatment of LN Type V With Gross Proteinuria
Official Title
Prospective Control Study of TW in the Treatment of LN Type V With Gross Proteinuria
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nanjing University School of Medicine

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lupus Nephritis, Proteinuria, CTX

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
immunosuppressor
Arm Type
Experimental
Arm Description
TW 30mg,q.d.*3 months and reduced into 20mg b.i.d
Intervention Type
Drug
Intervention Name(s)
tripterygium glycosides
Other Intervention Name(s)
TW
Intervention Description
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.
Primary Outcome Measure Information:
Title
To analyze the clinical effects of tripterygium glycosides (TW) in LN-V patients with gross proteinuria.
Time Frame
48 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hu Weixin, Doctor
Organizational Affiliation
Jinling Hospital, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Institute of Nephrology, Jinling Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Facility Name
Research Institute of Nephrology,Jinling Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China

12. IPD Sharing Statement

Learn more about this trial

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

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