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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Graft Rejection

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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everolimus

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No