drugset / Trial / NCT00420537
Shift to Everolimus (RAD) Kidney Sparing Study
RandomizedParallel-groupOpen-labelPrevention
Summary
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.
Timeline
- Start
- 2006-09
- Primary completion
- 2009-01
- Completion
- 2009-03
Publications
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cyclosporine | Peptide | — | — |
| Comparator | Everolimus | Small molecule | — | — |
| Comparator | Mycophenolate Mofetil | Small molecule | — | — |