Long-term Efficacy and Safety of Everolimus Versus Mycophenolate in Kidney Transplant Recipients Receiving Tacrolimus.

BACKGROUND: The short-term efficacy and safety of everolimus in combination with tacrolimus have been described in several clinical trials. Yet, detailed long-term data comparing the use of everolimus or mycophenolate in kidney transplant recipients receiving tacrolimus are lacking. METHODS: This is a 5-y follow-up post hoc analysis of a prospective trial including 288 patients who were randomized to receive a single 3-mg/kg dose of rabbit antithymocyte globulin, tacrolimus, everolimus (EVR), and prednisone (rabbit antithymocyte globulin/EVR, n = 85); basiliximab, tacrolimus, everolimus, and prednisone (basiliximab/EVR, n = 102); or basiliximab, tacrolimus, mycophenolate, and prednisone (basiliximab/mycophenolate, n = 101). RESULTS: There were no differences in the incidence of treatment failure (31.8% versus 40.2% versus 34.7%, P = 0.468), de novo donor-specific HLA antibodies (6.5% versus 11.7% versus 4.0%, P = 0.185), patient (92.9% versus 94.1% versus 92.1%, P = 0.854), and death-censored graft (87.1% versus 90.2% versus 85.1%, P = 0.498) survivals. Using a sensitive analysis, the trajectories of estimated glomerular filtration rate were comparable in the intention-to-treat (P = 0.145) and per protocol (P = 0.354) populations. There were no differences in study drug discontinuation rate (22.4% versus 30.4% versus 17.8%, P = 0.103). CONCLUSIONS: In summary, this analysis in a cohort of de novo low/moderate immunologic risk kidney transplant recipients suggests that the use of a single 3 mg/kg rabbit antithymocyte globulin dose followed by EVR combined with reduced tacrolimus concentrations was associated with similar efficacy and renal function compared with the standard of care immunosuppressive regimen.

Early hospital readmission after kidney transplantation under a public health care system.

Early hospital readmission (EHR) is associated with increased mortality after kidney transplantation. This is influenced by population demographics and the comprehensiveness of the healthcare system. We investigated the incidence and risk factors associated with EHR and 1-year patient and graft survivals. METHODS: We included all recipients of kidney transplant between 2011 and 2012. We excluded recipients younger than 18 years, retransplants and who died or lost the graft during the index hospital admission. RESULTS: Among 1175 recipients, the incidence of EHR was 26.6%. The main reasons for EHR were infection (67%), surgical complications (14%), and metabolic disturbances (11%). Independent risk factors associated with EHR were recipient age (OR = 1.95, 95% CI 1.46-2.63, P < 0.001), CMV serology negative (OR = 2.2, 95% CI 1.31-3.65, P = 0.003), use of rabbit anti-thymocyte globulin (OR = 2.06, 95% CI 1.33-3.13, P < 0.001), treatment for acute rejection during index hospitalization (OR = 1.68, 95% CI 1.15-2.47, P = 0.008), and length of stay (OR = 1.72, 95% CI 1.18-2.5, P = 0.005). Patient (88.8% vs 97.6%, P < 0.001) and death-censored graft (97.4% vs 99.0%, P < 0.001) survivals were inferior comparing patients with and without EHR. Conclusion EHR was independently associated with mortality (OR 4.01, 95% CI 2.13-7.54, P < 0.001), but its incidence and causes are directly related to the local characteristics of the population and healthcare system.