Delayed Introduction of Everolimus in De Novo Renal Transplanted Patients: A Single-Center Experience.
Pretagostini R, Poli L, et al.Transplantation Proceedings 2016; 48 (2): 326-8.
Aims
To evaluate the efficacy and safety of late introduction of everolimus (EVR) versus the maintenance of mycophenolate sodium (MPS) in kidney transplant recipients.
Interventions
Participants were randomised to receive either late EVR introduction (0.75 mg bid, adjusting the doses with the intent to maintain blood levels of 5-10 ng/mL) and tacrolimus (TAC) reduction (4-6 ng/mL level), versus standard immunosuppressive regimen (full-dose TAC with MPS).
Participants
49 de novo patients undergoing kidney transplantation.
Outcomes
The primary outcomes measured were patient and graft survival and acute rejection rates. Secondary measured outcomes were related to wound, metabolic, and hematologic complications.
Follow-up
1 year
CET Conclusions
This randomised study of only 49 patients showed a reduction in serum creatinine at one year after introduction of everolimus and tacrolimus reduction. The report is very short and does not present all the details that one might like to see, such as a participant flow chart, degree of sensitization and HLA mismatch and protocol biopsies. Most significantly there is no description of actual tacrolimus levels achieved, so we cannot be sure if the reduce target of tacrolimus levels had the desired impact. There was no blinding and it is unclear if there were cross-overs between the groups. There was no difference in one year survival or acute rejection episodes, although the study was underpowered for these outcomes. There were significant rises in total serum cholesterol and triglycerides, along with reduced haemoglobin and platelets associated with the use of everolimus.
Data analysis
Per protocol analysis
Trial registration
None