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

No results posted yet for this study

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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01646736 on ClinicalTrials.gov