274
Participants
Start Date
January 31, 2001
Primary Completion Date
October 31, 2007
Study Completion Date
August 31, 2010
Tacrolimus
Tacrolimus therapy was started immediately after transplantation with a continuous intravenous infusion of 0.01-0.03 mg/kg/d. After extubation, the mode of delivery was switched to oral administration (b.i.d.) with doses of 0.05-0.3 mg/kg/d. Tacrolimus doses were adjusted to trough levels. Target C0 (trough) levels were 10-15 ng/ml for the first 3 months after transplantation and 8-12 ng/ml thereafter with dose adjustments according to patient outcome.
Cyclosporine
Cyclosporine therapy was started immediately after transplantation with a continuous intravenous infusion of 1-3 mg/kg/d. After extubation the mode of delivery was switched to oral administration (b.i.d. or t.i.d.) with doses of 4-18 mg/kg/d. Cyclosporine doses were adjusted to C0 or C2 levels according to local practice. Target trough levels were 200 - 300 ng/ml for the first 3 months after transplantation and 150 - 200 ng/ml thereafter.
Centre hospitalier universitaire vaudois, Lausanne
Hospital Erasme, Brussels
Allgemeines Krankenhaus Wien, Vienna
Universitaire Ziekenhuizen, Leuven
Hospital Reina Sofia, Córdoba
Hospital Juan Canalejo, A Coruña
Universitätsklinikum Hamburg-Eppendorf, Hamburg
Universitätsklinikum Kiel, Kiel
Clínica Puerta de Hierro, Madrid
Hospital Marques de Valdecilla, Santander
Universitätsklinikum Essen, Essen
St. Vincent's Hospital, Sydney
Universitätsklinikum Jena, Jena
Hospital Vall d'Hebron, Barcelona
Universitätsklinikum Hamburg-Eppendorf
OTHER