Efficacy and Safety of Tripterygium Wilfordii in Patients With Lupus Nephritis

Nephritis, Lupus Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01646736
• Other study ID #: T2WILN
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: July 18, 2012
• Last updated: July 19, 2012
• Start date: July 2012
• Est. completion date: December 2013

Study information

• Verified date: July 2012
• Source: Peking Union Medical College Hospital
• Contact: Hua Chen, MD
• Phone: +861069158797
• Email: chenhua[@]pumch.cn
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: December 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis
• Nephritis, Lupus

Intervention

Drug:
• Tripterygium wilfordii Hook F
Oral T2(Tripterygium wilfordii Hook F) 20mg thrice daily for 24 weeks.
• Cyclophosphamide
Cyclophosphamide 1.0 intravenous every month.
• GC
Prednisone or equivalent 1 mg/kg/d(up to 60 mg), gradually tapering to 7.5mg/d in 24 weeks.

Locations

Country	Name	City	State
China	Deptment of Rheumatology, Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal Response	The proportion of patients achieving Complete Response (CR) and Partial Response(PR).	24 weeks.	No
Secondary	Renal Function	The change in glomerular filtration rate(GFR) from baseline to week 24.	24 weeks	No
Secondary	Serum Albumin Level	The change in serum albumin level from baseline to week 24.	24 weeks	No
Secondary	Complement	The change in complement components from baseline to week 24, including: CH50(total complement activity), C3 and C4 level measured by nephelometry.	24 weeks	No
Secondary	Anti-dsDNA	The change in anti-dsDNA antibody titers from baseline to week 24.	24 weeks	No