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Efficacy and Safety of Tripterygium Wilfordii in Patients With Lupus Nephritis

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ClinicalTrials.gov Identifier: NCT01646736
Recruitment Status : Unknown
Verified July 2012 by Fengchun Zhang, gwcmc.
Recruitment status was:  Recruiting
First Posted : July 20, 2012
Last Update Posted : July 23, 2012
Sponsor:
Information provided by (Responsible Party):
Fengchun Zhang, gwcmc

Brief Summary:
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 or disease Intervention/treatment Phase
Nephritis, Lupus Drug: Tripterygium wilfordii Hook F Drug: Cyclophosphamide Drug: GC Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : July 2012
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Renal Response [ Time Frame: 24 weeks. ]
    The proportion of patients achieving Complete Response (CR) and Partial Response(PR).


Secondary Outcome Measures :
  1. Renal Function [ Time Frame: 24 weeks ]
    The change in glomerular filtration rate(GFR) from baseline to week 24.

  2. Serum Albumin Level [ Time Frame: 24 weeks ]
    The change in serum albumin level from baseline to week 24.

  3. 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.

  4. Anti-dsDNA [ Time Frame: 24 weeks ]
    The change in anti-dsDNA antibody titers from baseline to week 24.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
gwcmc
Investigators
Principal Investigator: Fengchun Zhang, MD gwcmc

Responsible Party: Fengchun Zhang, Professor, gwcmc
ClinicalTrials.gov Identifier: NCT01646736     History of Changes
Other Study ID Numbers: T2WILN
First Posted: July 20, 2012    Key Record Dates
Last Update Posted: July 23, 2012
Last Verified: July 2012

Keywords provided by Fengchun Zhang, gwcmc:
Lupus Nephritis
Cyclophosphamide
Tripterygium

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