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

Novartis Pharmaceuticals

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Conditions

Graft Rejection

Interventions

everolimusDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (6)

UCLA Medical Center

Los Angeles, California, United States

University of Minnesota, Fairfield University Hospital

Minneapolis, Minnesota, United States

Columbia Presbyterian Medical Center

New York, New York, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Change in renal function at 6 assessed by comparing serum creatinine levels at 6 months to baseline values.

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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