Abstract
Early conversion to everolimus was assessed in kidney transplant recipients participating in the Eurotransplant Senior Program (ESP), a population in whom data are lacking. The SENATOR multicenter study enrolled 207 kidney transplant recipients undergoing steroid withdrawal at week 2 post-transplant (ClinicalTrials.gov [NCT00956293]). At week 7, patients were randomized (1:2 ratio) to continue the previous calcineurin inhibitor (CNI)-based regimen with mycophenolic acid (MPA) and cyclosporine or switch to a CNI-free regimen with MPA, everolimus (5–10 ng/mL) and basiliximab at weeks 7 and 12, then followed for 18 weeks to month 6 post-transplant. The primary endpoint was estimated GFR (eGFR). At week 7, 77/207 (37.2%) patients were randomized (53 everolimus, 24 control). At month 6, eGFR was comparable: 36.5±10.8ml/min with everolimus versus 42.0±13.0ml/min in the control group (p = 0.784). Discontinuation due to adverse events occurred in 27.8% of everolimus-treated patients and 0.0% of control patients (p = 0005). Efficacy profiles showed no difference. In conclusion, eGFR, safety and efficacy outcomes at month 6 post-transplant showed no difference between groups. The everolimus group experienced a higher rate of discontinuation due to adverse events. However, the high rate of non-randomization is highly relevant, indicating this to be a somewhat unstable patient population regardless of treatment.
Highlights
The transplant population is ageing [1]
Since two patients were randomized to the everolimus group but not converted from CsA, the full analysis set (FAS) consisted of 75 patients (51 patients in the everolimus group and 24 patients in the control group) (Table 1)
The proportion of patients with glomerulonephritis as the end-stage renal disease leading to KTx was nearly twice as high in the control group than in the everolimus group, but overall the two treatment groups were adequately balanced in terms of demographic and other baseline characteristics
Summary
The proportion of patients transplanted within the Eurotransplant Senior Program (ESP), which allocates grafts from donors aged over 65 years to recipients older than 65 years, has risen to more than 25% of all kidney transplant (KTx) patients in Europe [2]. Presenting with a high rate of co-morbidities on one hand, and decreased innate and adaptive immunity on the other [3], immunosuppressive regimens tailored for ESP transplant recipients have long been the subject of debate [4]. Older KTx recipients are at increased risk for infection and malignancy, and extended criteria donor (ECD) kidney grafts have higher rates of delayed graft function (DGF) and are more vulnerable to calcineurin-inhibitor (CNI)-induced toxicity [10]. A tailored immunosuppressive strategy is required for this subgroup of patients [15, 16]
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