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
2 other identifiers
interventional
N/A
1 country
6
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
December 1, 2004
CompletedFirst Posted
Study publicly available on registry
December 2, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2005
CompletedJuly 12, 2010
July 1, 2010
8 months
December 1, 2004
July 9, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in renal function at 6 assessed by comparing serum creatinine levels at 6 months to baseline values.
Secondary Outcomes (5)
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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
UCLA Medical Center
Los Angeles, California, 90095, United States
University of Minnesota, Fairfield University Hospital
Minneapolis, Minnesota, 55455, United States
Columbia Presbyterian Medical Center
New York, New York, 10032, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140, United States
Midstate Cardiology
Nashville, Tennessee, 37203, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Richard Dorent, MD
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
December 1, 2004
First Posted
December 2, 2004
Study Start
August 1, 2004
Primary Completion
April 1, 2005
Last Updated
July 12, 2010
Record last verified: 2010-07