Status:
COMPLETED
Safety/Efficacy of Everolimus and Neoral® in Adult Cardiac Transplant Patients With Established Allograft Vasculopathy
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Graft Rejection
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 immunosuppressiv...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00097968
Start Date
August 1 2004
Last Update
July 12 2010
Active Locations (6)
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1
UCLA Medical Center
Los Angeles, California, United States, 90095
2
University of Minnesota, Fairfield University Hospital
Minneapolis, Minnesota, United States, 55455
3
Columbia Presbyterian Medical Center
New York, New York, United States, 10032
4
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195