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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.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT00976300
Date of registration: 11/09/2009
Prospective Registration: No
Primary sponsor: Institute of Rheumatology, Prague
Public title: Cyclosporine A or Intravenous Cyclophosphamide for Lupus Nephritis: The Cyclofa-Lune Study CYCLOFA-LUNE
Scientific title: Cyclosporine A or Intravenous Cyclophosphamide for Lupus Nephritis: The Cyclofa-Lune Study
Date of first enrolment: January 2002
Target sample size: 40
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT00976300
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 2
Countries of recruitment
Czech Republic
Contacts
Key inclusion & exclusion 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 ┬Ámol/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
Health Condition(s) or Problem(s) studied
Lupus Nephritis
Systemic Lupus Erythematosus
Intervention(s)
Drug: Cyclophosphamide
Drug: Cyclosporine A
Primary Outcome(s)
renal remission and renal response [Time Frame: at the end of induction (month 9) and maintenance (month 18) phase]
Secondary Outcome(s)
incidence of adverse events and relapse free period [Time Frame: 18 months]
Secondary ID(s)
IGA MZ CR 8444-3
MZO 00023728
RU 8444-3
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Charles University, Czech Republic
Department of Rheumatology, Hospital, Ceske Budejovice, Czech Republic
Faculty Hospital St. Anna, Brno
Ministry of Health, Czech Republic
National Institute of Rheumatology, Piestany, Slovakia
Palacky University
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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