Conversion from Cyclosporine to Everolimus at 4.5 Months Posttransplant: 3-Year Results From the Randomized ZEUS Study.
Budde K, Lehner F, et al.American Journal of Transplantation, 12(6): 1528-1540, 2012.
Aims
To evaluate the efficacy and safety of conversion from cyclosporine (CsA) to everolimus in renal transplant recipients.
Interventions
Switch from CsA to everolimus at 4.5 months post-transplant versus continuation of CsA. All patients received induction therapy with basiliximab, enteric-coated mycophenolate sodium and corticosteroids.
Participants
300 kidney transplant recipients.
Outcomes
Renal function was measured as estimated glomerular filtration rate; treatment failure was defined as biopsy proved acute rejection, graft loss, death, loss to follow up, discontinuation due to lack of efficacy or toxicity, or conversion to another regimen; patient and graft survival, haematology and biochemistry assessment.
Follow-up
3 years
CET Conclusions
In this three year follow-up report of the ZEUS Study patients who were converted to everolimus at 4.5 months after transplant had better renal function if they were able to remain on everolimus compared to patients who continued on cyclosporine. However it should be noted that over 40% of patients randomised to everolimus changed their immunosuppressive regimen by 3 years.
Data analysis
Strict intention-to-treat analysis
Quality notes
This is a sub-analysis of a previous publication of the same RCT: Budde K, Becker T, Arns A, Sommerer C, Reinke P, Eisenberger U. Everolimus-based regimen calcineurin-inhibitor-free regimen in recipients of de-novo kidney transplants: An open-label, randomised, controlled trial. Lancet 2011; 377: 837–847. The methodological quality assessment was based on the previous publication.
Trial registration
NCT00154310 (ClinicalTrials.gov)