Induction Treatment of Proliferative Lupus Nephritis With Leflunomide Combined With Prednisone
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Purpose
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 |
|---|---|---|
|
Nephritis, Lupus |
Drug: leflunomide combined with prednisone |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase 3 Study of Leflunomide Combined With Prednisone Treatment of Proliferative Lupus Nephritis as Induction Therapy |
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations| China | |
| 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 | |
| Renal Division, Renji Hospital, Shanghai Jiaotong University | |
| Shanghai, China | |
| Department of Nephrology, Shanghai Changzheng Hospital | |
| Shanghai, China | |
| Renal Division, Huashan Hospital, Fudan University | |
| Shanghai, China | |
| Principal Investigator: | Haiyan Wang, M.D. | Institute of Nephrology, Peking University |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00268567 History of Changes |
| Other Study ID Numbers: | CLLNT-2002HL0133 |
| Study First Received: | December 21, 2005 |
| Last Updated: | December 21, 2005 |
| Health Authority: | China: Food and Drug Administration |
Additional relevant MeSH terms:
|
Lupus Nephritis Nephritis Glomerulonephritis Kidney Diseases Urologic Diseases Lupus Erythematosus, Systemic Connective Tissue Diseases Autoimmune Diseases Immune System Diseases Prednisone Leflunomide Glucocorticoids Hormones |
Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anti-Inflammatory Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors Antirheumatic Agents |
ClinicalTrials.gov processed this record on May 22, 2013