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

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01646736

Enrollment

130

Registered

2012-07-20

Start date

2012-07-31

Completion date

2013-12-31

Last updated

2012-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nephritis, Lupus

Keywords

Lupus Nephritis, Cyclophosphamide, Tripterygium

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.

Interventions

DRUGTripterygium wilfordii Hook F

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

DRUGCyclophosphamide

Cyclophosphamide 1.0 intravenous every month.

DRUGGC

Prednisone or equivalent 1 mg/kg/d(up to 60 mg), gradually tapering to 7.5mg/d in 24 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Renal Response	24 weeks.	The proportion of patients achieving Complete Response (CR) and Partial Response(PR).

Secondary

Measure	Time frame	Description
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.

Countries

China

Contacts

Primary ContactHua Chen, MD

chenhua@pumch.cn+861069158797

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026