NCT01646736

Efficacy and Safety of Tripterygium Wilfordii in Patients With Lupus Nephritis

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.

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
DRUG	Tripterygium wilfordii Hook F	Oral T2(Tripterygium wilfordii Hook F) 20mg thrice daily for 24 weeks.
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.

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-07-01
• Completion: 2013-12-01
• First posted: 2012-07-20
• Last updated: 2012-07-23

Locations

1 site across 1 country: China