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Sponsored by: |
Peking University |
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Information provided by: | Peking University |
ClinicalTrials.gov Identifier: | NCT00268567 |
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 | Intervention | Phase |
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Nephritis, Lupus |
Drug: leflunomide combined with prednisone |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase 3 Study of Leflunomide Combined With Prednisone Treatment of Proliferative Lupus Nephritis as Induction Therapy |
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
China | |
Renal Division, Peking University First Hospital | |
Beijing, China, 100034 | |
Division of Nephrology, Nanfang Hospital, Southern Medical University | |
Guangzhou, 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 | |
Department of Nephrology, Shanghai Changzheng Hospital | |
Shanghai, 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 | |
Renal Division, Huashan Hospital, Fudan University | |
Shanghai, China |
Principal Investigator: | Haiyan Wang, M.D. | Institute of Nephrology, Peking University |
Study ID Numbers: | CLLNT-2002HL0133 |
Study First Received: | December 21, 2005 |
Last Updated: | December 21, 2005 |
ClinicalTrials.gov Identifier: | NCT00268567 History of Changes |
Health Authority: | China: State Food and Drug Administration |
Anti-Inflammatory Agents Prednisone Glomerulonephritis Autoimmune Diseases Immunologic Factors Antineoplastic Agents, Hormonal Lupus Nephritis Hormone Antagonists Lupus Leflunomide |
Hormones, Hormone Substitutes, and Hormone Antagonists Immunosuppressive Agents Glucocorticoids Hormones Urologic Diseases Lupus Erythematosus, Systemic Nephritis Connective Tissue Diseases Kidney Diseases Antirheumatic Agents |
Anti-Inflammatory Agents Prednisone Glomerulonephritis Molecular Mechanisms of Pharmacological Action Immunologic Factors Lupus Nephritis Antineoplastic Agents Leflunomide Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Hormones Lupus Erythematosus, Systemic Urologic Diseases |
Therapeutic Uses Connective Tissue Diseases Kidney Diseases Autoimmune Diseases Immune System Diseases Antineoplastic Agents, Hormonal Enzyme Inhibitors Glucocorticoids Immunosuppressive Agents Pharmacologic Actions Nephritis Antirheumatic Agents |