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

July 9, 2010 updated by: Novartis Pharmaceuticals

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA Medical Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota, Fairfield University Hospital
    • New York
      • New York, New York, United States, 10032
        • Columbia Presbyterian Medical Center
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Midstate Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Richard Dorent, MD, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (Actual)

April 1, 2005

Study Registration Dates

First Submitted

December 1, 2004

First Submitted That Met QC Criteria

December 1, 2004

First Posted (Estimate)

December 2, 2004

Study Record Updates

Last Update Posted (Estimate)

July 12, 2010

Last Update Submitted That Met QC Criteria

July 9, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRAD001A2405
  • RAD/Certican

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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