Induction Treatment of Proliferative Lupus Nephritis With Leflunomide Combined With Prednisone

Nephritis, Lupus Clinical Trial

Official title:

Phase 3 Study of Leflunomide Combined With Prednisone Treatment of Proliferative Lupus Nephritis as Induction Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00268567
• Other study ID #: CLLNT-2002HL0133
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 21, 2005
• Last updated: December 21, 2005
• Start date: October 2002

Study information

• Verified date: October 2004
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis
• Nephritis, Lupus

Intervention

Drug:
• leflunomide combined with prednisone

Locations

Country	Name	City	State
China	Department of Nephrology, Kidney Center and key Lab of PLA, Chinese General Hospital of PLA	Beijing
China	Renal Division, Peking University First Hospital	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

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	complete remission of renal disease at 6 months
Secondary	partial remission at 6 months and adverse events