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

ClinicalTrials.gov ID: NCT00097968

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Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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 identification

NCT ID: NCT00097968
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Novartis Pharmaceuticals; Industry
Enrollment: Not listed

Conditions and interventions

Conditions

Graft Rejection

Interventions

everolimus Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 65 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Aug 2004 (Type not available)
Primary completion: Apr 2005 (Actual)
Completion: Not listed
Last update posted: Jul 12, 2010

Started 2004

United States locations

U.S. sites: 6
U.S. states: 6
U.S. cities: 6

Facility	City	State	ZIP	Site status
UCLA Medical Center	Los Angeles	California	90095	—
University of Minnesota, Fairfield University Hospital	Minneapolis	Minnesota	55455	—
Columbia Presbyterian Medical Center	New York	New York	10032	—
Cleveland Clinic Foundation	Cleveland	Ohio	44195	—
Temple University Hospital	Philadelphia	Pennsylvania	19140	—
Midstate Cardiology	Nashville	Tennessee	37203	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00097968, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jul 12, 2010 · Synced Nov 13, 2026