Back to resultsSafety/Efficacy of Everolimus and Neoral® in Adult Cardiac Transplant Patients With Established Allograft Vasculopathy
Primary Purpose
Graft Rejection
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
everolimus
Sponsored by
About this trial
This is an interventional prevention trial for Graft Rejection focused on measuring transplant, heart, adult, everolimus, allograft rejection
Eligibility Criteria
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.
Sites / Locations
- UCLA Medical Center
- University of Minnesota, Fairfield University Hospital
- Columbia Presbyterian Medical Center
- Cleveland Clinic Foundation
- Temple University Hospital
- Midstate Cardiology
Outcomes
Primary Outcome Measures
Change in renal function at 6 assessed by comparing serum creatinine levels at 6 months to baseline values.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00097968
First Posted
December 1, 2004
Last Updated
July 9, 2010
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT00097968
Brief Title
Safety/Efficacy of Everolimus and Neoral® in Adult Cardiac Transplant Patients With Established Allograft Vasculopathy
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2010
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
April 2005 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft Rejection
Keywords
transplant, heart, adult, everolimus, allograft rejection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
everolimus
Primary Outcome Measure Information:
Title
Change in renal function at 6 assessed by comparing serum creatinine levels at 6 months to baseline values.
Secondary Outcome Measure Information:
Title
Major Adverse Cardiac Events at 3 and 6 months.
Title
Patient survival at 3 and 6 months.
Title
Treated acute rejection at 3 and 6 months.
Title
Admission to the hospital at 3 and 6 months.
Title
Premature study treatment discontinuation at 3 and 6 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Dorent, MD
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
UCLA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of Minnesota, Fairfield University Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Columbia Presbyterian Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Midstate Cardiology
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Safety/Efficacy of Everolimus and Neoral® in Adult Cardiac Transplant Patients With Established Allograft Vasculopathy
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