Safety/Efficacy of Everolimus and Neoral® in Adult Cardiac Transplant Patients With Established Allograft Vasculopathy

Novartis

Status and phase: Completed; Phase 3

Conditions: Graft Rejection

Treatments: Drug: everolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00097968

CRAD001A2405

RAD/Certican

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)