Safety/Efficacy of Everolimus and Neoral® in Adult Cardiac Transplant Patients With Established Allograft Vasculopathy
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||An Open-Label, Single Arm, Pilot Study of the Renal Safety of Everolimus in Addition to Neoral® in Cardiac Transplant Recipients With Established Allograft Vasculopathy|
- Change in renal function at 6 assessed by comparing serum creatinine levels at 6 months to baseline values.
- Major Adverse Cardiac Events at 3 and 6 months.
- Patient survival at 3 and 6 months.
- Treated acute rejection at 3 and 6 months.
- Admission to the hospital at 3 and 6 months.
- Premature study treatment discontinuation at 3 and 6 months.
|Study Start Date:||August 2004|
|Primary Completion Date:||April 2005 (Final data collection date for primary outcome measure)|
|United States, California|
|UCLA Medical Center|
|Los Angeles, California, United States, 90095|
|United States, Minnesota|
|University of Minnesota, Fairfield University Hospital|
|Minneapolis, Minnesota, United States, 55455|
|United States, New York|
|Columbia Presbyterian Medical Center|
|New York, New York, United States, 10032|
|United States, Ohio|
|Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|United States, Pennsylvania|
|Temple University Hospital|
|Philadelphia, Pennsylvania, United States, 19140|
|United States, Tennessee|
|Nashville, Tennessee, United States, 37203|
|Study Director:||Richard Dorent, MD||Novartis Pharmaceuticals|