Graft Rejection
Conditions
Keywords
transplant, heart, adult, everolimus, allograft rejection
Brief summary
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.
Interventions
DRUGeverolimus
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in renal function at 6 assessed by comparing serum creatinine levels at 6 months to baseline values. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United States
Outcome results
None listed