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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00976300 |
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Date of registration:
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11/09/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Cyclosporine A or Intravenous Cyclophosphamide for Lupus Nephritis: The Cyclofa-Lune Study
CYCLOFA-LUNE |
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Scientific title:
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Cyclosporine A or Intravenous Cyclophosphamide for Lupus Nephritis: The Cyclofa-Lune Study |
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Date of first enrolment:
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January 2002 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00976300 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Czech Republic
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Systemic Lupus Erythematosus
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Lupus Nephritis
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Intervention(s)
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Drug: Cyclosporine A
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Drug: Cyclophosphamide
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Primary Outcome(s)
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renal remission and renal response
[Time Frame: at the end of induction (month 9) and maintenance (month 18) phase]
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Secondary Outcome(s)
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incidence of adverse events and relapse free period
[Time Frame: 18 months]
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Secondary ID(s)
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MZO 00023728
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IGA MZ CR 8444-3
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RU 8444-3
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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