Heart transplant patients on a standard care regimen of CNI, MMF, and corticosteroids will enter the study 4-6 weeks post-transplant. At 3 months after transplant, patients will be randomized to either continue this regimen or CNI therapy will be discontinued and replaced by sirolimus therapy (in combination with MMF and corticosteroids). The effect of these 2 regimens on efficacy, safety and renal function will be evaluated.The anticipated time on study treatment is 1-2 years and the target sample size is 500+ individuals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
1
Unnamed facility
Chicago, Illinois, United States
Unnamed facility
Maywood, Illinois, United States
Unnamed facility
Boston, Massachusetts, United States
Unnamed facility
Detroit, Michigan, United States
Unnamed facility
Minneapolis, Minnesota, United States
Unnamed facility
Cleveland, Ohio, United States
Unnamed facility
Philadelphia, Pennsylvania, United States
Unnamed facility
Charleston, South Carolina, United States
Unnamed facility
Memphis, Tennessee, United States
Unnamed facility
Dallas, Texas, United States
...and 19 more locations
Renal function assessed by calculated GFR at 24 months post-transplant, and incidence of biopsy-proven acute rejection (BPAR) or HDC, graft loss or lost to follow-up\n
Incidence of BPAR, number of episodes of BPAR per patient, time to first BPAR, incidence of re-transplant, death, rejection including antibody treated rejection, time to graft loss or death, rejection associated with HDC\n
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