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NCT Number: NCT00268567

Induction Treatment of Proliferative Lupus Nephritis With Leflunomide Combined With Prednisone

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.

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Key information

Conditions

Nephritis, Lupus Autoimmune Diseases Connective Tissue Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glomerulonephritis Immune System Diseases Kidney Diseases Lupus Erythematosus, Systemic Lupus Nephritis Male Urogenital Diseases Nephritis Skin and Connective Tissue Diseases Urogenital Diseases Urologic Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Nephrology, Kidney Center and key Lab of PLA, Chinese General Hospital of PLA, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

leflunomide combined with prednisone

Drug

Primary outcomes

  1. complete remission of renal disease at 6 months

Secondary outcomes

  1. partial remission at 6 months and adverse events

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Official study title

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

Important dates

Study start
2002
First posted
Dec 22, 2005
Registry last updated
Dec 22, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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