drugset / Trial / NCT00976300
Cyclosporine A or Intravenous Cyclophosphamide for Lupus Nephritis: The Cyclofa-Lune Study
Phase 2
Completed
40 enrolled
Institute of Rheumatology, Prague
Charles University, Czech Republic · collabDepartment of Rheumatology, Hospital, Ceske Budejovice, Czech Republic · collabMinistry of Health, Czech Republic · collabNational Institute of Rheumatology, Piestany, Slovakia · collabPalacky University · collabSt. Anna Hospital, Brno, Czech · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2002-01
- Primary completion
- 2008-05
- Completion
- 2009-04
Publications
- Background Rihova Z, Vankova Z, Maixnerova D, Dostal C, Jancova E, Honsova E, Merta M, Rysava R, Tesar V. Treatment of lupus nephritis with cyclosporine - an outcome analysis. Kidney Blood Press Res. 2007;30(2):124-8. doi: 10.1159/000101448. Epub 2007 Mar 30.
- Background Dostal C, Tesar V, Rychlik I, Zabka J, Vencovsky J, Bartunkova J, Stejskalova A, Tegzova D. Effect of 1 year cyclosporine A treatment on the activity and renal involvement of systemic lupus erythematosus: a pilot study. Lupus. 1998;7(1):29-36. doi: 10.1191/096120398678919714.
- Background Yee CS, Gordon C, Dostal C, Petera P, Dadoniene J, Griffiths B, Rozman B, Isenberg DA, Sturfelt G, Nived O, Turney JH, Venalis A, Adu D, Smolen JS, Emery P. EULAR randomised controlled trial of pulse cyclophosphamide and methylprednisolone versus continuous cyclophosphamide and prednisolone followed by azathioprine and prednisolone in lupus nephritis. Ann Rheum Dis. 2004 May;63(5):525-9. doi: 10.1136/ard.2002.003574.
- Zavada J, Pesickova S, Rysava R, Olejarova M, Horak P, Hrncir Z, Rychlik I, Havrda M, Vitova J, Lukac J, Rovensky J, Tegzova D, Bohmova J, Zadrazil J, Hana J, Dostal C, Tesar V. Cyclosporine A or intravenous cyclophosphamide for lupus nephritis: the Cyclofa-Lune study. Lupus. 2010 Oct;19(11):1281-9. doi: 10.1177/0961203310371155. Epub 2010 Jul 6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cyclophosphamide | Other / unclassified | 10 mg | Intravenous |
| Subject | Cyclosporine | Peptide | 1.25 mg/kg | Oral |
| Subject | Cyclosporine | Peptide | 3.75 mg/kg | Oral |