Clinical Experience with Everolimus (Certican) in Elderly Recipients: The ???Old-for-Old??? Concept

Abstract

With an increasing number of elderly patients now waiting for a kidney transplant, and the percentage of kidney donors over 55 years also rising, harvesting older kidneys specifically for use in older recipients is a way of extending the donor pool for renal transplantation. Two case studies from an everolimus (Certican) Phase III trial (A2306) are presented. They illustrate clinical experience of achieving stable graft function in the "old-for-old" kidney transplant program at the Ramon y Cajal Hospital in Madrid, Spain. The first case study demonstrates that stable graft function can be achieved in an "old-for-old" kidney transplant patient, who receives everolimus in combination with reduced-exposure cyclosporine (CsA). To optimize graft function in the long-term, CsA C(2) blood levels should be <400 ng/ml. The second case study highlights how "old-for-old" renal transplant recipients can be at risk of calcineurin-inhibitor (CNI)-induced nephrotoxicity. Here, graft function did not improve following CsA dose reduction; thus, CsA was withdrawn 1 year posttransplant. Stable graft function that is acceptable for an "old-for-old" kidney transplant was then achieved with everolimus trough blood levels of 10-15 ng/ml and low-dose prednisone. In these cases, everolimus was used safely and effectively in the "old-for-old" kidney transplant setting. Its combination with reduced-exposure CsA, or its facilitation of CsA withdrawal, minimized the risk of nephrotoxicity in the older renal graft. These findings need to be confirmed in larger studies specific to this population.