Cyclosporine Sparing Effect of Enteric-Coated Mycophenolate Sodium in De Novo Kidney Transplantation.
Lee SH, Park JB, et al.Yonsei Medical Journal 2017; 58(1): 217-225.
Aims
To compare the efficacy and tolerability in de novo kidney recipients of reduced-dose cyclosporine (CsA) with standard-dose enteric-coated mycophenolate sodium (EC-MPS), versus standard-dose CsA with reduced-dose EC-MPS, combined with basiliximab and corticosteroids.
Interventions
Participants were randomly assigned to either the investigational group (low dose CsA+standard dose EC-MPS) or the control group (standard dose CsA+low dose EC-MPS).
Participants
140 de novo kidney transplant recipients aged 20–65 years.
Outcomes
The primary outcome measured was renal graft function. Other measured outcomes included incidences of adverse events (AEs) and serious AEs, and a composite variable of the incidence of efficacy failure that included biopsy-confirmed acute rejection, graft loss, death, or loss to follow-up until six months post-transplantation.
Follow-up
6 months
CET Conclusions
This study arises from four centres in South Korea and is a comparison between standard dose cyclosporine with low dose enteric-coated mycophenolate sodium (control arm) and low dose cyclosporine with standard dose EC-MPS (Investigative arm). This was a noninferiority study with analysis at six months where the primary end-point was renal function and secondary end-points were the incidence of efficacy failure. The mean estimated GFR was non-inferior in the investigational group compared to the control group and the incidence of biopsy confirmed graft rejection was not statistically different in the two groups. Adverse events were evenly distributed between the two groups. Thus, in this population of low risk recipients of a renal transplant (50% living donor) the use of low dose cyclosporine with standard dose enteric-coated MPS was similar to more conventional immunosuppression with standard dose cyclosporine and low dose EC-MPS.
Data analysis
Modified intention-to-treat analysis
Trial registration
ClinicalTrials.gov - NCT01817322