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Induction Treatment of Proliferative Lupus Nephritis With Leflunomide Combined With Prednisone

NCT ID: NCT00268567

Last Updated: 2005-12-22

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

COMPLETED

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Brief Summary

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lupus nephritis accounts for the most morbidity and mortality in patients with SLE. Glucocorticoids combined with cyclophosphamide (CYC) are effective for the treatment of patients with proliferative lupus nephritis and have been the immunosuppressive regimen of choice for many years. However, some patients do not respond well to the regimen, and adverse effects of cyclophosphamide limit its use in certain patients. Leflunomide is a novel immunosuppressive agent currently used in the treatment of rheumatoid arthritis.There were a few pilot observational studies and reports suggesting leflunomide was also safe, well-tolerated and may be effective in SLE patients without important organ involvement. It has not been shown if leflunomide can be used in the treatment of patients with lupus nephritis. We therefore undertook a multi-center, controlled study to investigate the efficacy and safety profile of leflunomide compared with cyclophosphamide in the treatment of patients with biopsy proven proliferative lupus nephritis.

Detailed Description

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Conditions

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Nephritis, Lupus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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leflunomide combined with prednisone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* All patients were diagnosed as SLE according to the updated criteria of American College of Rheumatology in 1997, had a systemic lupus erythematosus disease activity index (SLEDAI)equal or greater than 8; had evident renal diseases and biopsy-documented diffuse proliferative or focal proliferative lupus nephritis, with or without coincident membranous nephropathy, and pathological activity index (AI)equal or greater than 4

Exclusion Criteria

* Patients who had received cyclophosphamide within the previous 3 months, cerebral lupus, severe infection, liver disease, pregnancy, and anticipated poor compliance with the protocol.
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University

OTHER

Sponsor Role lead

Principal Investigators

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Haiyan Wang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Institute of Nephrology, Peking University

Locations

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Renal Division, Peking University First Hospital

Beijing, , China

Site Status

Department of Nephrology, Kidney Center and key Lab of PLA, Chinese General Hospital of PLA

Beijing, , China

Site Status

Division of Nephrology, Nanfang Hospital, Southern Medical University

Guangzhou, , China

Site Status

Renal Division, the First Affiliated Hospital, Sun Yat-sen University

Guangzhou, , China

Site Status

Department of Rheumatology, the Second Affiliated Hospital, Harbin Medical University

Harbin, , China

Site Status

Department of Nephrology, Shanghai Changzheng Hospital

Shanghai, , China

Site Status

Renal Division, Huashan Hospital, Fudan University

Shanghai, , China

Site Status

Renal Division, Renji Hospital, Shanghai Jiaotong University

Shanghai, , China

Site Status

Countries

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China

Other Identifiers

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CLLNT-2002HL0133

Identifier Type: -

Identifier Source: org_study_id