De novo use of everolimus with elimination or minimization of cyclosporine in renal transplant recipients.
Novoa, PA, Grinyo JM, et al.Transplantation Proceedings 43(9): 3331-3339, 2011.
Aims
To evaluate early cyclosporine (CsA) elimination versus minimization from an everolimus-CsA-steroid regimen in de novo renal transplant patients.
Interventions
CsA elimination after 3 months from transplantation versus CsA minimisation until 12 months. All patients received everolimus and steroids.
Participants
114 renal transplant recipients.
Outcomes
The primary efficacy endpoint was renal function measured by estimated glomerular filtration rate (GFR) using Nankivell formula. Secondary efficacy endpoints included estimated GFR at 6 months and estimated GFR using the MDRD4 formula at 12 months. Other outcomes included incidences of composite efficacy failure defined as BPAR, graft loss, death, or lost to follow-up, and individual efficacy endpoints at 12 months.
Follow-up
12 months
CET Conclusions
Two similarly designed randomised trials were combined for analysis because of recruitment difficulties, a major weakness of the report. CsA elimination after 3 months from transplantation compared with CsA minimisation until 12 months showed that the results were similar in both studies and that renal function was stable in patients in whom CsA was discontinued while on everolimus.
Data analysis
Modified intention-to-treat analysis
Trial registration
Not reported