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Induction Treatment of Proliferative Lupus Nephritis With Leflunomide Combined With Prednisone
This study has been completed.
First Received: December 21, 2005   No Changes Posted
Sponsored by: Peking University
Information provided by: Peking University
ClinicalTrials.gov Identifier: NCT00268567
  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 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

Resource links provided by NLM:


Further study details as provided by Peking University:

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

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

Study Start Date: October 2002
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00268567

Locations
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
Sponsors and Collaborators
Peking University
Investigators
Principal Investigator: Haiyan Wang, M.D. Institute of Nephrology, Peking University
  More Information

No publications provided

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

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on September 10, 2009