Risk factors associated with efficacy outcomes in kidney transplantation: analysis of a contemporary cohort of patients from the A2309 trial.
Colussi G, Vergara M, et al.Clinical Nephrology 2015 Jun; 83(6): 338-44.
Aims
To analyse risk factors for a composite endpoint of treated biopsy proven acute rejection (BPAR), graft loss, death, or loss to follow-up in a recent cohort.
Interventions
Patients were randomised to three groups and received everolimus with reduced cyclosporine (trough concentration 3-8 ng/mL) or (trough concentration 6-12 ng/mL), versus mycophenolic acid with standard cyclosporine.
Participants
833 de novo kidney transplant recipients aged 18-70 years
Outcomes
Primary outcomes measured were efficacy failure, graft loss, death or loss to follow-up.
Follow-up
24 months
CET Conclusions
In this study the authors have evaluated in a multivariate analysis risk factors in a cohort of patients from the A2309 trial. In this trial two doses of everolimus with reduced dose cyclosporine was compared with MPA and standard dose cyclosporine. The interventional arms using everolimus were not inferior to MPA and cyclosporine. In this study the authors were able to show in their multivariate analysis that quite independently of the type of immunosuppression used, the major impact on outcomes were delayed graft function, donor age, recipient age, race and gender. Outcomes were assessed by a composite end-point comprising acute rejection, graft loss and patient death over the first two years after transplantation of de novo kidneys.
Data analysis
Strict intention-to-treat analysis
Quality notes
Score based on the previous study Tedesco Silva, et al. Everolimus Plus Reduced-Exposure CsA versus Mycophenolic Acid Plus Standard-Exposure CsA in Renal-Transplant Recipients. Am J Transplant 2010;10(6):1401-13
Trial registration
None