Cyclosporine A or Intravenous Cyclophosphamide for Lupus Nephritis: The Cyclofa-Lune Study

• Status: Completed
• Trial end date: 2009-04-01
• Target enrollment: 0
• Participant gender: All

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 has been suggested to be an efficient and safe treatment alternative to cyclophosphamide. In a randomized, multicenter, open-label, controlled trial the investigators sought to compare the efficacy of oral cyclosporine A with intravenous pulse cyclophosphamide to induce durable remission in patients with lupus nephritis III-IV.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Rheumatology, Prague
• Collaborators: Charles University, Czech Republic; Department of Rheumatology, Hospital, Ceske Budejovice, Czech Republic; Ministry of Health, Czech Republic; National Institute of Rheumatology, Piestany, Slovakia; Palacky University; St. Anna Hospital, Brno, Czech
• Treatments: Cyclophosphamide; Cyclosporine; Cyclosporins

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.