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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
130
Oral T2(Tripterygium wilfordii Hook F) 20mg thrice daily for 24 weeks.
Cyclophosphamide 1.0 intravenous every month.
Prednisone or equivalent 1 mg/kg/d(up to 60 mg), gradually tapering to 7.5mg/d in 24 weeks.
Deptment of Rheumatology, Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGRenal Response
The proportion of patients achieving Complete Response (CR) and Partial Response(PR).
Time frame: 24 weeks.
Renal Function
The change in glomerular filtration rate(GFR) from baseline to week 24.
Time frame: 24 weeks
Serum Albumin Level
The change in serum albumin level from baseline to week 24.
Time frame: 24 weeks
Complement
The change in complement components from baseline to week 24, including: CH50(total complement activity), C3 and C4 level measured by nephelometry.
Time frame: 24 weeks
Anti-dsDNA
The change in anti-dsDNA antibody titers from baseline to week 24.
Time frame: 24 weeks
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