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Efficacy and Safety of Tripterygium Wilfordii in Patients With Lupus Nephritis

NCT ID: NCT01646736

Last Updated: 2012-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-12-31

Brief Summary

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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

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Conditions

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Nephritis, Lupus

Keywords

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Lupus Nephritis Cyclophosphamide Tripterygium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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GC+CYC

Patients were treated with Glucocorticosteroid and Cyclophosphamide.

Group Type PLACEBO_COMPARATOR

Cyclophosphamide

Intervention Type DRUG

Cyclophosphamide 1.0 intravenous every month.

GC

Intervention Type DRUG

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

GC+T2

Patients were treated with Glucocorticosteroid and oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F).

Group Type EXPERIMENTAL

Tripterygium wilfordii Hook F

Intervention Type DRUG

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

GC

Intervention Type DRUG

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

Interventions

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Tripterygium wilfordii Hook F

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

Intervention Type DRUG

Cyclophosphamide

Cyclophosphamide 1.0 intravenous every month.

Intervention Type DRUG

GC

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Fengchun Zhang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Fengchun Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Deptment of Rheumatology, Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hua Chen, MD

Role: CONTACT

Phone: +861069158797

Email: [email protected]

Facility Contacts

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Fengchun Zhang, MD

Role: primary

Other Identifiers

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T2WILN

Identifier Type: -

Identifier Source: org_study_id