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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Nephritis, Lupus
 Drug: Tripterygium wilfordii Hook F
Drug: Cyclophosphamide
Drug: GC
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Peking Union Medical College Hospital:

Primary Outcome Measures:
  • Renal Response [ Time Frame: 24 weeks. ] [ Designated as safety issue: No ]
    The proportion of patients achieving Complete Response (CR) and Partial Response(PR).


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 130
Study Start Date: July 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01646736

Contacts
Contact: Hua Chen, MD +861069158797 chenhua@pumch.cn

Locations
China, Beijing
Deptment of Rheumatology, Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100032
Contact: Fengchun Zhang, MD     861069158792     ZhangFCcra@yahoo.com.cn    
Principal Investigator: Fengchun Zhang, MD            
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
Principal Investigator: Fengchun Zhang, MD Peking Union Medical College Hospital
  More Information

No publications provided

Responsible Party: Fengchun Zhang, Professor, Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT01646736     History of Changes
Other Study ID Numbers: T2WILN
Study First Received: July 18, 2012
Last Updated: July 19, 2012
Health Authority: China: National Natural Science Foundation

Keywords provided by Peking Union Medical College Hospital:
Lupus Nephritis
Cyclophosphamide
Tripterygium

Additional relevant MeSH terms:
Lupus Nephritis
Nephritis
Glomerulonephritis
Kidney Diseases
Urologic Diseases
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Cyclophosphamide
Immunosuppressive Agents
 Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists

ClinicalTrials.gov processed this record on May 21, 2013