Induction Treatment of Proliferative Lupus Nephritis With Leflunomide Combined With Prednisone

Phase 2

Completed

• Conditions: Nephritis, Lupus

• Registration Number: NCT00268567
• Lead Sponsor: Peking University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-10
• Status Verified: 2004-10
• Study First Submitted: 2005-12-21
• Study First Submitted QC: 2005-12-21
• Last Update Submitted: 2005-12-21
• Study First Posted: 2005-12-22
• Last Update Posted: 2005-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
complete remission of renal disease at 6 months

Secondary Outcome Measures

Name	Time	Method
partial remission at 6 months and adverse events

Trial Locations

Locations (8)

Renal Division, Peking University First Hospital; 🇨🇳 Beijing, 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, 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

Division of Nephrology, Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, China