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Induction Treatment of Proliferative Lupus Nephritis With Leflunomide Combined With Prednisone

NCT00268567 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2005-12-22

No results posted yet for this study

Summary

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.

Conditions

  • Nephritis, Lupus

Interventions

DRUG

leflunomide combined with prednisone

Sponsors & Collaborators

  • Peking University

    lead OTHER

Principal Investigators

  • Haiyan Wang, M.D. · Institute of Nephrology, Peking University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-10-31

Countries

  • China

Study Locations

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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 NCT00268567 on ClinicalTrials.gov