Status:
COMPLETED
Cyclosporine A or Intravenous Cyclophosphamide for Lupus Nephritis: The Cyclofa-Lune Study
Lead Sponsor:
Institute of Rheumatology, Prague
Collaborating Sponsors:
Ministry of Health, Czech Republic
Charles University, Czech Republic
Conditions:
Systemic Lupus Erythematosus
Lupus Nephritis
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
Intravenous cyclophosphamide is considered to be the standard of care for treatment of proliferative lupus nephritis. However, its use is limited by potentially severe toxic effects. Cyclosporine A ha...
Detailed Description
Lupus nephritis occurs in 30-40% of adults with systemic lupus erythematosus and is associated with increased morbidity and mortality. Focal and diffuse proliferative forms of lupus nephritis are know...
Eligibility Criteria
Inclusion
- the diagnosis of systemic lupus erythematosus (by meeting 4 criteria of the American College of Rheumatology)
- renal biopsy documenting lupus nephritis according to the classification of the World Health Organization (WHO) or the updated International Society of Nephrology/Renal Pathology Society (ISN/RPS) as proliferative glomerulonephritis class III (focal) or IV (diffuse)
- clinical activity as defined by presence of at least two of the following:
- abnormal proteinuria (more than 500mg of protein in in a 24-hour urine specimen)
- abnormal microscopic hematuria, or
- C3 hypocomplementemia (the latter two were defined according to the norms in the laboratories of the participating centers)
Exclusion
- treatment with cyclophosphamide or cyclosporine A ever before
- treatment with other immunosuppressive drugs (such as azathioprine or mycophenolate mofetil) or high dose glucocorticoids (≥ 80mg of prednisone or methylprednisolone) within the last 3 months
- persistent elevation of serum creatinine (≥140 μmol/l)
- pregnancy or lactation
- bone marrow insufficiency with cytopenias not attributable to SLE, and 8severe coexisting conditions, such as infection, liver disease, active peptic ulcer etc.
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00976300
Start Date
January 1 2002
End Date
April 1 2009
Last Update
June 23 2010
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Rheumatology, Faculty of Medicine, Charles University in Prague
Hradec Králové, Czechia
2
Department of Rheumatology, Faculty of Medicine, Palacky University
Olomouc, Czechia
3
Department of Nephrology, General Teaching Hospital and First faculty of Medicine, Charles University in Prague
Prague, Czechia, 12800
4
Institute of Rheumatology
Prague, Czechia, 12850