Efficacy and Safety of Tripterygium Wilfordii in Patients With Lupus Nephritis

Phase 2

• Conditions: Nephritis, Lupus
• Interventions: Drug: Cyclophosphamide; Drug: Tripterygium wilfordii Hook F; Drug: GC

• Registration Number: NCT01646736
• Lead Sponsor: Peking Union Medical College Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-07
• Study Start: 2012-07
• Study First Submitted: 2012-07-18
• Study First Submitted QC: 2012-07-18
• Last Update Submitted: 2012-07-19
• Study First Posted: 2012-07-20
• Last Update Posted: 2012-07-23
• Primary Completion: 2013-07
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GC+CYC	Cyclophosphamide	Patients were treated with Glucocorticosteroid and Cyclophosphamide.
GC+T2	Tripterygium wilfordii Hook F	Patients were treated with Glucocorticosteroid and oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F).
GC+CYC	GC	Patients were treated with Glucocorticosteroid and Cyclophosphamide.
GC+T2	GC	Patients were treated with Glucocorticosteroid and oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F).

Primary Outcome Measures

Name	Time	Method
Renal Response	24 weeks.	The proportion of patients achieving Complete Response (CR) and Partial Response(PR).

Secondary Outcome Measures

Name	Time	Method
Renal Function	24 weeks	The change in glomerular filtration rate(GFR) from baseline to week 24.
Serum Albumin Level	24 weeks	The change in serum albumin level from baseline to week 24.
Complement	24 weeks	The change in complement components from baseline to week 24, including: CH50(total complement activity), C3 and C4 level measured by nephelometry.
Anti-dsDNA	24 weeks	The change in anti-dsDNA antibody titers from baseline to week 24.

Trial Locations

Locations (1)

Deptment of Rheumatology, Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China