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A cluster of adverse events in everolimus arm was noted.
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The purpose of this study is to verify if the combination of Everolimus with a very low dose of cyclosporine is more effective than the combination of mycophenolate mofetil with low-dose of cyclosporine in reducing the progression of kidney dysfunction in patients with heart transplantation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| mycophenolate | Active Comparator | Mycophenolate mofetil with cyclosporine trough levels between 100 and 150 |
|
| Everolimus | Active Comparator | Everolimus with cyclosporine trough levels between 40 and 90 ng/ml |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cyclosporine | Drug | cyclosporine trough levels between 100 and 150 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Calculated GFR | One year after randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angelo Branzi, MD | Alma Mater Studiorum University of Bologna | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico S.Orsola-Malpighi | Bologna | 40138 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16387066 | Background | Lehmkuhl H, Ross H, Eisen H, Valantine H. Everolimus (certican) in heart transplantation: optimizing renal function through minimizing cyclosporine exposure. Transplant Proc. 2005 Dec;37(10):4145-9. doi: 10.1016/j.transproceed.2005.10.005. | |
| 12944570 | Background | Eisen HJ, Tuzcu EM, Dorent R, Kobashigawa J, Mancini D, Valantine-von Kaeppler HA, Starling RC, Sorensen K, Hummel M, Lind JM, Abeywickrama KH, Bernhardt P; RAD B253 Study Group. Everolimus for the prevention of allograft rejection and vasculopathy in cardiac-transplant recipients. N Engl J Med. 2003 Aug 28;349(9):847-58. doi: 10.1056/NEJMoa022171. |
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| ID | Term |
|---|---|
| D016572 | Cyclosporine |
| D009173 | Mycophenolic Acid |
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D003524 | Cyclosporins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
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| cyclosporine |
| Drug |
cyclosporine trough levels between 40 and 90 ng/ml |
|
| Mycophenolate mofetil | Drug | mycophenolate with low doses |
|
| Everolimus | Drug |
|
| D010455 |
| Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |