Induction Treatment of Proliferative Lupus Nephritis With Leflunomide Combined With Prednisone
Phase 3 Study of Leflunomide Combined With Prednisone Treatment of Proliferative Lupus Nephritis as Induction Therapy
1 other identifier
interventional
N/A
1 country
8
Brief 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.
Trial Health
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8 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2002
CompletedFirst Submitted
Initial submission to the registry
December 21, 2005
CompletedFirst Posted
Study publicly available on registry
December 22, 2005
CompletedDecember 22, 2005
October 1, 2004
December 21, 2005
December 21, 2005
Conditions
Outcome Measures
Primary Outcomes (1)
complete remission of renal disease at 6 months
Secondary Outcomes (1)
partial remission at 6 months and adverse events
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients who had received cyclophosphamide within the previous 3 months, cerebral lupus, severe infection, liver disease, pregnancy, and anticipated poor compliance with the protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Renal Division, Peking University First Hospital
Beijing, 100034, China
Department of Nephrology, Kidney Center and key Lab of PLA, Chinese General Hospital of PLA
Beijing, China
Division of Nephrology, Nanfang Hospital, Southern Medical University
Guangzhou, 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
Renal Division, Huashan Hospital, Fudan University
Shanghai, China
Renal Division, Renji Hospital, Shanghai Jiaotong University
Shanghai, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Haiyan Wang, M.D.
Institute of Nephrology, Peking University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 21, 2005
First Posted
December 22, 2005
Study Start
October 1, 2002
Last Updated
December 22, 2005
Record last verified: 2004-10