Efficacy and Safety of Tripterygium Wilfordii in Patients With Lupus Nephritis
NCT01646736 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 130
Last updated 2012-07-23
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.
Conditions
- Nephritis, Lupus
Interventions
- DRUG
-
Tripterygium wilfordii Hook F
Oral T2(Tripterygium wilfordii Hook F) 20mg thrice daily for 24 weeks.
- DRUG
-
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.
Sponsors & Collaborators
-
Peking Union Medical College Hospital
lead OTHER
Principal Investigators
-
Fengchun Zhang, MD · Peking Union Medical College Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2012-07-31
- Primary Completion
- 2013-07-31
- Completion
- 2013-12-31
Countries
- China
Study Locations
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