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The purpose of the study is to determine the extent of cyclosporine microemulsion dose reduction required to maintain stable renal function in maintenance cardiac transplant recipients, after initiation of everolimus.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Everolimus (RAD001) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Comparing calculated glomerular filtration rate (GFR) at Month 3 (Week 12) to Baseline and by comparing the daily cyclosporine dose at Month 3 (Week 12) to Baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of acute rejection episode greater than or equal to grade 3A. | ||
| Safety laboratory tests including lipid profiles, hematology and proteinuria. | ||
| Incidence of premature study treatment discontinuation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20050127 | Result | Ross H, Pflugfelder P, Haddad H, Cantarovich M, White M, Ignaszewski A, Howlett J, Vaillancourt M, Dorent R, Burton JR; CADENCE Study Group (CAnadian Pilot Sutdy to Determine Safe and Effective Dosing of Neoral and CErtican in Stable Cardiac Transplant Recipients). Reduction of cyclosporine following the introduction of everolimus in maintenance heart transplant recipients: a pilot study. Transpl Int. 2010 Jan;23(1):31-7. doi: 10.1111/j.1432-2277.2009.00940.x. |
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| ID | Term |
|---|---|
| D000068338 | Everolimus |
| ID | Term |
|---|---|
| D020123 | Sirolimus |
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
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| Incidence of serious adverse avents (SAEs). |
| Incidence of admission to the hospital. |