188
Participants
Start Date
December 31, 2012
Primary Completion Date
March 31, 2015
Study Completion Date
March 31, 2015
tacrolimus
Arm 1 : tacrolimus (C0 6-10 ng/ml) from D3-D5 post-transplantation to month 6 post-transplantation. Arm 2 : tacolimus (C0 6-10 ng/ml) from D3-D5 post-transplantation to 16 weeks post-transplantation at the latest.
everolimus
Arm 1: no everolimus Arm 2: everolimus (C0 6-10 ng/ml) from randomization to month 6 post-transplantation
Basiliximab
Basiliximab was supplied to the participating centers as marketed, i.e. in packs containing one vial of 20-mg powder, and water for injection (WFI). 20 mg at D0 and D4
Mycophenolic Acid
Dose of 1440 mg/day from transplantation to month 6 post- transplantation
Corticosteroids
Administration of oral corticosteroid therapy was at the discretion of the centers according to their usual practice
Novartis Investigative Site, Marseille
Novartis Investigative Site, Besançon
Novartis Investigative Site, Toulouse
Novartis Investigative Site, Bordeaux
Novartis Investigative Site, Montpellier
Novartis Investigative Site, Rennes
Novartis Investigative Site, Chambray-lès-Tours
Novartis Investigative Site, Grenoble
Novartis Investigative Site, Lille
Novartis Investigative Site, Paris
Novartis Investigative Site, Clichy
Novartis Investigative Site, Créteil
Novartis Investigative Site, Villejuif
Novartis Investigative Site, Nice
Lead Sponsor
Novartis Pharmaceuticals
INDUSTRY