Clinical trial NCT00268567: Induction Treatment of Proliferative Lupus Nephritis With Leflunomide Combined With Prednisone
Official title: Phase 3 Study of Leflunomide Combined With Prednisone Treatment of Proliferative Lupus Nephritis as Induction Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Nephritis, Lupus
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2005-12-22
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: complete remission of renal disease at 6 months
Secondary outcomes:
measure: partial remission at 6 months and adverse events
Other outcomes:
Locations:
city: Beijing
country: China
facility: Renal Division, Peking University First Hospital
city: Beijing
country: China
facility: Department of Nephrology, Kidney Center and key Lab of PLA, Chinese General Hospital of PLA
city: Guangzhou
country: China
facility: Division of Nephrology, Nanfang Hospital, Southern Medical University
city: Guangzhou
country: China
facility: Renal Division, the First Affiliated Hospital, Sun Yat-sen University
city: Harbin
country: China
facility: Department of Rheumatology, the Second Affiliated Hospital, Harbin Medical University
city: Shanghai
country: China
facility: Department of Nephrology, Shanghai Changzheng Hospital
city: Shanghai
country: China
facility: Renal Division, Huashan Hospital, Fudan University
city: Shanghai
country: China
facility: Renal Division, Renji Hospital, Shanghai Jiaotong University
Study officials:
affiliation: Institute of Nephrology, Peking University
name: Haiyan Wang, M.D.
role: PRINCIPAL_INVESTIGATOR
References: