Clinical Trials Directory

Trials / Completed

CompletedNCT00097968

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

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

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
Sponsor
Novartis Pharmaceuticals · Industry
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

Summary

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.

Conditions

Interventions

TypeNameDescription
DRUGeverolimus

Timeline

Start date
2004-08-01
Primary completion
2005-04-01
First posted
2004-12-02
Last updated
2010-07-12

Locations

6 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT00097968. Inclusion in this directory is not an endorsement.