Efficacy and Safety of Tripterygium Wilfordii in Patients With Lupus Nephritis

July 19, 2012 updated by: Fengchun Zhang, Peking Union Medical College Hospital

Evaluation of Efficacy and Safety of Glucocorticosteroid Combined With Oral T2 (Chloroform/Methanol Extract of Tripterygium Wilfordii Hook F) in the Treatment of Patients With Lupus Nephritis.

Evaluation the clinical efficacy and safety profile of glucocorticosteroid combined with oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F) in the treatment of patients with lupus nephritis. Open-labeled, randomized, prospective multi-center clinical trial. Observation period of 24 weeks.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

130

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

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

Study Contact

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100032
        • Recruiting
        • Deptment of Rheumatology, Peking Union Medical College Hospital
        • Principal Investigator:
          • Fengchun Zhang, MD
        • Contact:

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 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 18-65 years with informed consent
  • SLE defined by meeting 4 or more ACR classification criteria
  • Biopsy-proven active proliferative lupus glomerulonephritis ISN classification Class III or IV
  • Active renal disease

Exclusion Criteria:

  • Pregnant, lactating or further fertility requirements
  • Serum creatinine > 3 mg/dL
  • Serum ALT or AST > 3 times upper limit of normal
  • Severe, progressive renal, hepatic, hematological, gastrointestinal, pulmonary, cardiovascular, neurological, endocrine or cerebral disease
  • Previous treated with cyclophosphamide or T2.
  • Not discontinuing MMF, azathioprine, leflunomide, methotrexate, calcineurin inhibitor before 1 month of randomization.
  • Active or chronic infection, including HIV, HCV, HBV, tuberculosis
  • Patient with malignancy

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: GC+CYC
Patients were treated with Glucocorticosteroid and Cyclophosphamide.
Drug: Cyclophosphamide
Cyclophosphamide 1.0 intravenous every month.
Drug: GC
Prednisone or equivalent 1 mg/kg/d(up to 60 mg), gradually tapering to 7.5mg/d in 24 weeks.
EXPERIMENTAL: GC+T2
Patients were treated with Glucocorticosteroid and oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F).
Drug: Tripterygium wilfordii Hook F
Oral T2(Tripterygium wilfordii Hook F) 20mg thrice daily for 24 weeks.
Drug: GC
Prednisone or equivalent 1 mg/kg/d(up to 60 mg), gradually tapering to 7.5mg/d in 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renal Response
Time Frame: 24 weeks.
The proportion of patients achieving Complete Response (CR) and Partial Response(PR).
24 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renal Function
Time Frame: 24 weeks
The change in glomerular filtration rate(GFR) from baseline to week 24.
24 weeks
Serum Albumin Level
Time Frame: 24 weeks
The change in serum albumin level from baseline to week 24.
24 weeks
Complement
Time Frame: 24 weeks
The change in complement components from baseline to week 24, including: CH50(total complement activity), C3 and C4 level measured by nephelometry.
24 weeks
Anti-dsDNA
Time Frame: 24 weeks
The change in anti-dsDNA antibody titers from baseline to week 24.
24 weeks

Collaborators and Investigators

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

Sponsor

Peking Union Medical College Hospital

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

July 1, 2012

Primary Completion (ANTICIPATED)

July 1, 2013

Study Completion (ANTICIPATED)

December 1, 2013

Study Registration Dates

First Submitted

July 18, 2012

First Submitted That Met QC Criteria

July 18, 2012

First Posted (ESTIMATE)

July 20, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

July 23, 2012

Last Update Submitted That Met QC Criteria

July 19, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T2WILN

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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