Induction Treatment of Proliferative Lupus Nephritis With Leflunomide Combined With Prednisone

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00268567
Recruitment Status : Completed
First Posted : December 22, 2005
Last Update Posted : December 22, 2005
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Nephritis, Lupus Drug: leflunomide combined with prednisone Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 3 Study of Leflunomide Combined With Prednisone Treatment of Proliferative Lupus Nephritis as Induction Therapy
Study Start Date : October 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Primary Outcome Measures :
  1. complete remission of renal disease at 6 months

Secondary Outcome Measures :
  1. partial remission at 6 months and adverse events

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00268567

Renal Division, Peking University First Hospital
Beijing, China, 100034
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
Sponsors and Collaborators
Peking University
Principal Investigator: Haiyan Wang, M.D. Institute of Nephrology, Peking University Identifier: NCT00268567     History of Changes
Other Study ID Numbers: CLLNT-2002HL0133
First Posted: December 22, 2005    Key Record Dates
Last Update Posted: December 22, 2005
Last Verified: October 2004

Additional relevant MeSH terms:
Lupus Nephritis
Lupus Erythematosus, Systemic
Kidney Diseases
Urologic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents