Conditions: Graft Rejection Kidney Transplant Renal Allograft Recipients Renal Transplant
Keywords: renal transplant immunosuppression sirolimus/rapamune planned transition
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 254
Healthy volunteers: no

Brief summary:
This study will look at the effect on long-term kidney function using tacrolimus right after a transplant and then switching to sirolimus at 3 to 5 months after the transplant.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Tacrolimus intervention 2: Sirolimus intervention 3: Tacrolimus
Intervention descriptions: intervention 1: During the screening phase, tacrolimus is provided by the investigator (not the Sponsor) and is dosed to achieve a target trough level determined by the investigator. Therefore, the dosage form, dosage, and frequency are determined by the investigator. Duration of treatment is from transplantation until randomization (from 90 to 150 days). intervention 2: Following randomization, sirolimus is provided by the Sponsor in 1 and 2 mg oral tablets. Sirolimus is dosed once daily to achieve a target trough level of 7 to 15 ng/mL in the 1st year post-transplant and 5 - 15 ng/mL in the 2nd year post-transplant. Duration of treatment is from randomization through 2 years post-transplant (19 to 21 months). intervention 3: During the study, tacrolimus is provided by the investigator (not the Sponsor) and is dosed to achieve a target trough level determined by the investigator. Therefore, the dosage form, dosage, and frequency are determined by the investigator. Duration of treatment is 2 years post-transplant.

Protocol document: