Conditions: Renal Transplant
Allocation: NON_RANDOMIZED | Intervention model: SINGLE_GROUP
Enrollment: 79
Healthy volunteers: no

Brief summary:
Primary : To evaluate the efficacy of sirolimus assessed by the incidence of biopsy-confirmed acute rejection episode at 6 months after transplantation in Korean renal transplantation recipients.

Secondary :

1. To evaluate the safety of sirolimus over 12 months after transplantation in Korean renal transplantation recipients.
2. To evaluate graft function, patient survival and graft survival at 6 and 12 months after transplantation, and to investigate the incidence of biopsy-confirmed acute rejection episode at 12 months after transplantation.

Detailed description:

Arms:

Interventions: intervention 1: Sirolimus (Rapamune®)
Intervention descriptions: intervention 1: (1mg tablets): Initial loading dose of 6mg/day, followed by maintenance dose of 2mg/day, which was adjusted to specified trough level.

Protocol document: