Everolimus and Long-term Clinical Outcomes in Kidney Transplant Recipients: A Registry-based 10-year Follow-up of 5 Randomized Trials

Tracey Ying, Germaine Wong, Wai H. Lim, Philip Clayton, John Kanellis, Helen Pilmore, Scott Campbell, Philip J. O'Connell, Graeme Russ, Steven Chadban

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3 Citations (Scopus)

Abstract

BACKGROUND: Data regarding the long-term efficacy of everolimus-based immunosuppression for kidney transplantation are lacking. Existing randomized controlled trials are limited by short follow-up duration which limits capacity to assess impact on graft and patient survival. METHODS: We linked individual trial participants to the Australian and New Zealand Dialysis and Transplant Registry. Using a 1-step meta-analysis approach, we investigated the 10-year risk of graft loss, mortality and graft function in 349 participants from 5 randomized trials of everolimus-based immunosuppression. RESULTS: Two hundred forty-two patients randomized to everolimus and 107 control patients were followed for a median of 9 years (interquartile range, 7.1, 9.8 y). There were no significant differences in the risk of all-cause graft loss (adjusted hazard ratio [HR], 1.16; 95% confidence interval [CI], 0.69-1.94), mortality (adjusted HR, 1.51; 95% CI, 0.78-2.93) and death-censored graft loss in everolimus versus control (adjusted HR, 1.00; 95% CI, 0.50-2.01). For patients in the early initiation (de novo or <6-month conversion) everolimus trials (n = 279), decline in estimated glomerular filtration rate did not significantly differ with control (mean difference in the slope of estimated glomerular filtrate rate, 0.01 mL/min per 1.73 m [-0.06 to +0.09]). CONCLUSIONS: This registry-based analysis with long-term follow-up found no differences in graft and recipient survival or graft function for everolimus over current standard of care.

Original languageEnglish
Pages (from-to)1705-1713
Number of pages9
JournalTransplantation
Volume103
Issue number8
DOIs
Publication statusPublished - 1 Aug 2019

Cite this

Ying, T., Wong, G., Lim, W. H., Clayton, P., Kanellis, J., Pilmore, H., Campbell, S., O'Connell, P. J., Russ, G., & Chadban, S. (2019). Everolimus and Long-term Clinical Outcomes in Kidney Transplant Recipients: A Registry-based 10-year Follow-up of 5 Randomized Trials. Transplantation, 103(8), 1705-1713. https://doi.org/10.1097/TP.0000000000002499