Efficacy and Safety of Tripterygium Wilfordii in Patients With Lupus Nephritis

This study is currently recruiting participants.
Verified July 2012 by Peking Union Medical College Hospital
Sponsor:
Information provided by (Responsible Party):
Fengchun Zhang, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT01646736
First received: July 18, 2012
Last updated: July 19, 2012
Last verified: July 2012

July 18, 2012
July 19, 2012
July 2012
July 2013   (final data collection date for primary outcome measure)
Renal Response [ Time Frame: 24 weeks. ] [ Designated as safety issue: No ]
The proportion of patients achieving Complete Response (CR) and Partial Response(PR).
Same as current
Complete list of historical versions of study NCT01646736 on ClinicalTrials.gov Archive Site
  • Renal Function [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    The change in glomerular filtration rate(GFR) from baseline to week 24.
  • Serum Albumin Level [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    The change in serum albumin level from baseline to week 24.
  • Complement [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    The change in complement components from baseline to week 24, including: CH50(total complement activity), C3 and C4 level measured by nephelometry.
  • Anti-dsDNA [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    The change in anti-dsDNA antibody titers from baseline to week 24.
  • Renal Function [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    The change in glomerular filtration rate(GFR) from baseline to week 24.
  • Serum Albumin Level [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    The change in serum albumin level from baseline to week 24.
  • Complement [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    The change in complement components from baseline to week 24.
  • Anti-dsDNA [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    The change in anti-dsDNA antibody titers from baseline to week 24.
Not Provided
Not Provided
 
Efficacy and Safety of Tripterygium Wilfordii in Patients With Lupus Nephritis
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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Nephritis, Lupus
  • Drug: Tripterygium wilfordii Hook F
    Oral T2(Tripterygium wilfordii Hook F) 20mg thrice daily for 24 weeks.
  • 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.
  • Placebo Comparator: GC+CYC
    Patients were treated with Glucocorticosteroid and Cyclophosphamide.
    Interventions:
    • Drug: Cyclophosphamide
    • Drug: GC
  • Experimental: GC+T2
    Patients were treated with Glucocorticosteroid and oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F).
    Interventions:
    • Drug: Tripterygium wilfordii Hook F
    • Drug: GC
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
130
December 2013
July 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Hua Chen, MD +861069158797 chenhua@pumch.cn
China
 
NCT01646736
T2WILN
Yes
Fengchun Zhang, Peking Union Medical College Hospital
Peking Union Medical College Hospital
Not Provided
Principal Investigator: Fengchun Zhang, MD Peking Union Medical College Hospital
Peking Union Medical College Hospital
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP