152
Participants
Start Date
October 31, 2008
Primary Completion Date
April 30, 2010
Study Completion Date
April 30, 2015
cyclosporine
"Cyclosporine (Group 1):~basiliximab dose: 1x20 mg IV on Day 0 and 1x20 mg IV on Day 4~Cyclosporine: 8 mg/kg PO given before surgery, followed by 2x4 mg/kg/d. C-0h levels: month 1: 150-250 ng/ml; month 2: 100-200 ng/ml; month 3: withdrawal steroids: 100-150 ng/ml.~C-2h levels: month 1: 900-1100 ng/ml; month 2: 800-1000 ng/ml; month 3: withdrawal steroids: maintain level of 750 ng/ml~Enteric-coated mycophenolate(MPA):720mg PO pre-operatively followed by 1.44 g/day.~Steroids: pre-operatively: 250mg methylprednisolone IV; day 1:125mg IV.~Methylprednisolone:day 2-30:PO 12mg/d; day 31-60:tapered to 8mg/d ,day 61-90 :4mg/d; Month 3:stop"
Everolimus
"Everolimus (Group 2):~Basiliximab dose: idem as in group 1~Cyclosporine: first three months idem group 1; month 3: decreased dose by 50%, simultaneously initiate everolimus at a starting dose of 0.75 mg bid.~Once the everolimus blood levels range 6 - 12 ng/ml, cyclosporine will be stopped.~Enteric-coated mycophenolate (MPA) dosing idem as group 1.~Everolimus starting dose: 0.75 mg bid, trough levels: 6-12 ng/ml.~Steroid dosing: idem group 1, but maintained at 4 mg methylprednisolone after day 60."
RECRUITING
Erasme University Hospital, Brussels
RECRUITING
University Hospital Brussels, Brussels
RECRUITING
University Hospital Antwerp, Edegem
RECRUITING
University Hospital of Liege, Liège
RECRUITING
University Hospital, Ghent, Ghent
Collaborators (1)
Novartis Pharmaceuticals
INDUSTRY
Erasme University Hospital
OTHER
University Hospital, Ghent
OTHER
University of Liege
OTHER
Universitair Ziekenhuis Brussel
OTHER
University Hospital, Antwerp
OTHER