330
Participants
Start Date
April 30, 2009
Primary Completion Date
July 31, 2012
Study Completion Date
July 31, 2012
everolimus
Everolimus (Certican®) was provided in blisters containing tablets of 0.25 mg and 0.75 mg. Everolimus was initiated within 48 hours after graft reperfusion and it was administered orally.
cyclosporine
Cyclosporine for microemulsion (CsA, Sandimmun® Neoral®) was coadministered with everolimus at the same time of the day. CsA was available in alu-alu blisters containing soft gelatine capsules of 100 mg, 50 mg, 25 mg and 10 mg. Oral solution, as bottles containing 50 mL of solution (100 mg/mL) has been provided and used in case the drug had been administered to patients by nasogastric tube immediately after transplant.
Prednison (continuous steroids)
continuous steroids
Novartis Investigative Site, Torino
Novartis Investigative Site, Genova
Novartis Investigative Site, Milan
Novartis Investigative Site, Novara
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Novartis Investigative Site, Perugia
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Novartis Investigative Site, Brescia
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Novartis Investigative Site, Rome
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Lead Sponsor
Novartis
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