Philadelphia,
Pennsylvania
19140
Purpose:
Everolimus is an immunosuppressive drug that is being studied for preventing acute rejection
that can happen after heart transplantation.
It is usually used in combination with other immunosuppressive drugs such as cyclosporine.
The purpose of this study is to evaluate the change in kidney function after beginning
everolimus, while determining the most effective Neoral® (cyclosporine) dose to take with
everolimus, in adult cardiac transplant patients who have had their transplanted heart for
at least 1 year and who have cardiac allograft vasculopathy.
Criteria:
Inclusion Criteria:
- Male or female adult with an established cardiac allograft vasculopathy defined as
any new luminal irregularity on coronary angiography.
- Patient must be on statins at study entry.
- Patient who is more than 12 months post-transplant.
Exclusion Criteria:
- Patient with a serum creatinine value >2.0 mg/dL.
- Patient with a biopsy-proven acute rejection episode (>= ISHLT 3A) within 6 months
prior to study entry.
- Patient who had received any investigational drug within 4 weeks prior to study
entry.