327
Participants
Start Date
March 31, 2009
Primary Completion Date
March 31, 2014
Study Completion Date
July 31, 2014
Anti R-IL2 + Cyclosporine
"* anti R-IL2 induction (Simulect ®, 20 mg D0 and D4)~* Mycophenolate Mofetil (Cellcept ®) 3 grams per day beginning at D0~* cyclosporine A (Neoral ®) started from 6 to 8 mg/kg adjusted to C2~* corticosteroids 250 mg IV before and after surgery, then 1 mg/kg one week and 20mg/j the week after, then tapered until 10 mg/j at M1, 5 mg at M3 and stop between M4 and M6"
Thymoglobulin + Everolimus
"* Thymoglobulin ® induction started at 1.5mg/kg/j then adjusted to CD2 or total lymphocytes count, for 5 days~* Mycophenolate Mofetil (Cellcept ®) 3 grams per day beginning at D0~* everolimus (Certican ®): 4 to 6 mg/day started at D5, adjusted to achieve a residual level between 6 et 10 ng/ml~* corticosteroids 250 mg IV before and after surgery, then 1 mg/kg one week and 20mg/j the week after, then tapered until 10 mg/j at M1, 5 mg at M3 and stop between M4 and M6"
Anti R-IL2 + Cyclosporine then Everolimus
"* anti R-IL2 induction (Simulect ®, 20 mg D0 and D4)~* Mycophenolate Mofetil (Cellcept ®) 3 g/d beginning at D0~* cyclosporine A (Neoral ®) beginning at 6 to 8 mg/kg adjusted to C2, then switch to everolimus (Certican ®) between at W6, started at 3 mg/d, then adjusted to achieve a residual level between 6 et 10 ng/ml~* corticosteroids 250 mg IV before and after surgery, then 1 mg/kg one week and 20mg/j the week after, then tapered until 10 mg/j at M1, 5 mg at M3 and stop between M4 and M6"
CHRU de BREST, Brest
CHU Amiens, Amiens
CHU Pellegrin - Bordeaux, Bordeaux
CHU Cote de Nacre, Caen
CHU Clermont Ferrand, Clermont-Ferrand
CHU Dijon, Dijon
CHU Lille, Lille
CHU Limoges, Limoges
CHU Montpellier, Montpellier
CHU Nice, Nice
AP-HP Hopital Necker, Paris
CHU Poitiers, Poitiers
CHU Reims, Reims
CHU Rennes, Rennes
CHU Rouen, Rouen
Hopitaux Universitaires de Strasbourg, Strasbourg
CHU Rangueil - Toulouse, Toulouse
CHU Tours, Tours
Collaborators (1)
Novartis
INDUSTRY
Roche Pharma AG
INDUSTRY
Genzyme, a Sanofi Company
INDUSTRY
Ministry of Health, France
OTHER_GOV
University Hospital, Brest
OTHER