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

Information source: Institute of Rheumatology, Prague
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Systemic Lupus Erythematosus; Lupus Nephritis

Intervention: Cyclosporine A (Drug); Cyclophosphamide (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Institute of Rheumatology, Prague

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: renal remission and renal response

Secondary outcome: incidence of adverse events and relapse free period

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 known to progress to chronic renal failure unless treated by immunosuppressive drugs. Cyclophosphamide and glucocorticoids are considered to be the standard of care for patients with proliferative lupus nephritis. However, cyclophosphamide may cause a number of toxic effects, such as bone marrow suppression, premature gonadal failure, hemorrhagic cystitis, opportunistic infections, and malignant disease. Hence, efforts are being made to find alternative therapeutic approaches. Cyclosporine is a potent immunosuppressive agent with a more selective mode of action through its unique effect on T cell mediated responses, and is widely used to treat a spectrum of autoimmune and glomerular diseases. Several retrospective series and one randomized trial provided evidence that Cyclosporine A could represent an efficient and safe therapy for proliferative lupus nephritis. In a randomized, multicenter, open-label, controlled trial we compared the efficacy of oral cyclosporine A with intravenous pulse cyclophosphamide to induce durable remission in patients with proliferative lupus nephritis.

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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.

Locations and Contacts

Department of Rheumatology, Faculty of Medicine, Charles University in Prague, Hradec Kralove, Czech Republic

Department of Rheumatology, Faculty of Medicine, Palacky University, Olomouc, Czech Republic

Department of Nephrology, General Teaching Hospital and First faculty of Medicine, Charles University in Prague, Prague 12800, Czech Republic

Institute of Rheumatology, Prague 12850, Czech Republic

Additional Information

Related publications:

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. Epub 2007 Mar 30.

Dostál C, Tesar V, Rychlík I, Zabka J, Vencovský J, Bartûnková J, Stejskalová 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.

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.

Starting date: January 2002
Last updated: June 22, 2010

Page last updated: August 23, 2015

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