Este ensayo fue diseñado para abordar cuestiones importantes que afectan a los receptores de aloinjertos hepáticos y a los clínicos, es decir, la función renal, la reducción o suspensión precoz de tacrolimus postrasplante y la tasa de progresión de la fibrosis en pacientes positivos para el virus de la hepatitis C (VHC).
Este estudio de 24 meses constó de un período de selección, un período basal (de 3 a 7 días postrasplante) seguido de un período de rodaje que concluyó el día de la aleatorización a los 30 días (± 5 días) postrasplante. Los pacientes fueron seleccionados para determinar su elegibilidad antes del trasplante hepático. Los pacientes que habían recibido un trasplante hepático exitoso fueron iniciados en un régimen basado en tacrolimus que incluía corticosteroides e ingresaron al período basal (entre 3 y 7 días postrasplante). A los 30 (± 5) días postrasplante, los pacientes que cumplían criterios adicionales de inclusión/exclusión para la aleatorización fueron aleatorizados en el estudio.
After everolimus whole blood trough levels were confirmed to be in the target range of 3-8 ng/mL, tacrolimus tapering began, achieving a target tacrolimus whole blood trough level of 3-5 ng/mL by 3 weeks after randomization, a level which was maintained for the duration of the study.
After everolimus whole blood trough levels were confirmed to be in the target range of 3-8 ng/mL, tacrolimus tapering began, achieving a target tacrolimus whole blood trough level of 3-5 ng/mL by 3 weeks after randomization. Tacrolimus elimination was started beginning at Month 4. Tacrolimus was tapered after everolimus whole blood trough levels were within the target range of 6-10 ng/mL. Tacrolimus was completely eliminated by the end of Month 4.
Tacrolimus trough levels were targeted to be maintained at 8-12 ng/mL until Month 4. At Month 4, tacrolimus whole blood trough levels were decreased to a target trough level of 6-10 ng/mL for the remainder of the study.
Everolimus was started within 24 hours of randomization at a dose of 1.0 mg twice a day (bid, 2 mg daily dose). The dose was adjusted to maintain everolimus trough blood levels between 3-8 ng/mL for the duration of the study.
Everolimus was started within 24 hours of randomization at a dose of 1.0 mg twice a day (bid, 2 mg daily dose). The dose was adjusted to maintain everolimus trough blood levels between 3-8 ng/mL until Month 4; beginning with Month 4, the dose was adjusted to maintain everolimus trough blood levels between 6-10 ng/mL.
For patients in all groups, corticosteroids were initiated at or prior to the time of transplantation according to local practice. Corticosteroids could be used for the duration of the study but could not be eliminated before Month 6.
Buenos Aires, Buenos Aires, Argentina
Buenos Aires, Buenos Aires, Argentina
Buenos Aires, Buenos Aires, Argentina
San Martín, Buenos Aires, Argentina
Rosario, Santa Fe Province, Argentina