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...
Date First Received: December 21, 2005
Last Updated: December 21, 2005
Verified by: Peking University, October 2004
Clinical Trial Phase: Phase 2/Phase 3 | Start Date: October 2002
Overall Status: Completed
Brief Summary
Official Title: “Phase 3 Study of Leflunomide Combined With Prednisone Treatment of Proliferative Lupus Nephritis as Induction Therapy”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Outcome Measures for this Clinical Trial
Primary:
- complete remission of renal disease at 6 months
Secondary:
- partial remission at 6 months and adverse events
Criteria for Participation in this Clinical Trial
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.
Clinical Trials Locations, Contact Details, and Sponsors
Lead Sponsor: Peking University
Renal Division, Peking University First Hospital
Beijing 100034 China
Division of Nephrology, Nanfang Hospital, Southern Medical University
Guangzhou China
Renal Division, Renji Hospital, Shanghai Jiaotong University
Shanghai China
Department of Nephrology, Kidney Center and key Lab of PLA, Chinese General Hospital of PLA
Beijing China
Renal Division, Huashan Hospital, Fudan University
Shanghai China
Renal Division, the First Affiliated Hospital, Sun Yat-sen University
Guangzhou China
Department of Rheumatology, the Second Affiliated Hospital, Harbin Medical University
Harbin China
Department of Nephrology, Shanghai Changzheng Hospital
Shanghai China
Overall Clinical Trial Officials and Contacts
Haiyan Wang, M.D. Principal Investigator Institute of Nephrology, Peking University
Additional Information
Information obtained from ClinicalTrials.gov on July 18, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00268567
Study ID Number: CLLNT-2002HL0133
ClinicalTrials.gov Identifier: NCT00268567
Health Authority: China: State Food and Drug Administration
Clinical Trials Authorship and Review
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