186
Participants
Start Date
May 2, 2014
Primary Completion Date
October 10, 2018
Study Completion Date
October 10, 2018
Everolimus
"Everolimus : 0.75 bid, targeted to 3-8 ng/ml~Cyclosporin A :~CsA target ranges for Arm 1 will be 100-200 ng/mL from Day 3 to Month 2, decreasing to 75-150 ng/mL from Month 2 to Month 4 and 25-50 ng/mL from Months 6 to 12.~Corticosteroids :~Méthylprednisolone: 500 mg at Day 0, 120 mg à Day 1. Prednisone or equivalent: 20 mg/d from Day 3. Corticosteroid dosing will be tapered according to center standard practice but to not less than 5 mg per day for the duration of the 12-month study~Basiliximab :Day 0: 20 mg ; Day 4: 20 mg"
mycophenolic acid
"Mycophenolic acid :~1080 mg bid for one month, then 720 mg bid~Cyclosporin A :~CsA target ranges for Arm 1 will be 100-200 ng/mL from Day 3 to Month 2, decreasing to 75-150 ng/mL from Month 2 to Month 4 and 25-50 ng/mL from Months 6 to 12.~Corticosteroids :~Méthylprednisolone: 500 mg at Day 0, 120 mg à Day 1. Prednisone or equivalent: 20 mg/d from Day 3. Corticosteroid dosing will be tapered according to center standard practice but to not less than 5 mg per day for the duration of the 12-month study~Basiliximab :Day 0: 20 mg ; Day 4: 20 mg"
CHRU Caen - Hôpital de Caen, Caen
CHU La Cavale Blanche, Brest
CHU de Toulouse - Hôpital Rangueil, Toulouse
CHU de Bordeaux, Bordeaux
Hôpital Edouard Herriot, Lyon
APHP - Hôpital Necker, Paris
APHP - Kremlin Bicetre, Paris
CHU de Limoges - Hôpital Dupuytren, Limoges
CHRU Strasbourg, Strasbourg
Collaborators (1)
Novartis
INDUSTRY
University Hospital, Bordeaux
OTHER