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| ID | Type | Description | Link |
|---|---|---|---|
| RAD/Certican |
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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| everolimus | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change in renal function at 6 assessed by comparing serum creatinine levels at 6 months to baseline values. |
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardiac Events at 3 and 6 months. | ||
| Patient survival at 3 and 6 months. | ||
| Treated acute rejection at 3 and 6 months. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Dorent, MD | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Medical Center | Los Angeles | California | 90095 | United States | ||
| University of Minnesota, Fairfield University Hospital |
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| Admission to the hospital at 3 and 6 months. |
| Premature study treatment discontinuation at 3 and 6 months. |
| 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 |
| ID | Term |
|---|---|
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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