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ISRCTN
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ISRCTN34265870
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ClinicalTrials.gov identifier
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Public title
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A randomized trial comparing cyclosporine versus azathioprine for maintenance therapy in diffuse lupus nephritis
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Scientific title
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Acronym
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N/A
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Serial number at source
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NEO-I-22
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Study hypothesis
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Not provided at time of registration
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Italy
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Disease/condition/study domain
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Lupus nephritis
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Participants - inclusion criteria
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Seventy five patients presenting with diffuse proliferative lupus nephritis
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/01/2000
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Anticipated end date
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31/12/2004
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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75
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Interventions
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Administration of 3 intravenous methylprednisolone pulses followed by a 2-3 month treatment with prednisone and oral cyclophosphamide. Patients with serum creatinine ≤1.5 mg/dl, proteinuria ≥0.5 g per day and diastolic blood pressure <90 mmHg were then randomized to receive cyclosporine or azathioprine for two years.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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The study was sponsored by Novartis and monitored by an external society. The steering committee approved the study protocol, case report forms, statistical analysis plan, progress of the study and analysis, as well as the reporting of the data, whatever the outcome of the study. The sponsors could comment on the manuscript before submission, but the final version was the sole responsibility of the authors. In addition, the steering committee had full access to the data files of the study.
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Trial website
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Publications
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2006 results on http://www.ncbi.nlm.nih.gov/pubmed/17699309
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Contact name
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Prof
Claudio
Ponticelli
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Address
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via Ampere 126
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City/town
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Milano
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Zip/Postcode
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20131
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Country
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Italy
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Sponsor
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Novartis Farma (Italy)
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Address
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Largo U. Boccioni 1
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City/town
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Origgio
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Zip/Postcode
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21040
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Country
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Italy
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Tel
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+39 (0)2 9654 2351
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Fax
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+39 (0)2 9654 2318
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Email
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simona.greco@pharma.novartis.com
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Sponsor website:
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http://www.novartis.com/
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Date applied
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07/07/2004
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Last edited
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11/02/2008
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Date ISRCTN assigned
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22/11/2004
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