Five-Year Results of a Randomized Trial Comparing De Novo Sirolimus and Cyclosporine in Renal Transplantation: The Spiesser Study.
Lebranchu Y, Snanoudj R, et al.American Journal of Transplantation, 12(7):1801-1810, 2012.
Aims
To compare the efficacy and safety of a sirolimus and mycophenolate mofetil (MMF)-based immunosuppression regimen with a cyclosporine MMF-based regimen in renal transplant patients.
Interventions
Sirolimus versus cyclosporine. All patients received antithymocyte globulins, MMF and corticosteroids.
Participants
131 deceased donor kidney transplant recipients with a functional graft at one year.
Outcomes
The primary outcome measure was renal function assed by the estimated glomerular filtration rate at 5 years after transplantation. Other outcomes included creatinine clearance, the rates of acute graft rejection, graft loss and patient death, mean hemoglobin levels, cholesterol and triglyceride concentrations. Safety assessment included adverse events such as malignancies and new onset diabetes after transplantation.
Follow-up
5 years post-transplantation
CET Conclusions
This is a 5-year follow-up of the SPIESSER study where patients had been randomised to either a sirolimus or a cyclosporine based regimen. 131 patients who were living with a functional graft at one year were observed over the next 4 years. There was a better creatinine clearance in patients on sirolimus but no other differences in terms of patient survival, graft survival or acute rejection. It also confirmed a high rate of discontinuation of sirolimus due to adverse events.
Data analysis
Strict intention-to-treat analysis
Quality notes
This is a subgroup analysis of a previous publication of the same RCT: Buchler M, Caillard S, Barbier S, et al. Sirolimus versus cyclosporine in kidney recipients receiving thymoglobulin, mycophenolate mofetil and a 6-month course of steroids. Am J Transplant, 2007; 7: 2522–2531. The methodological quality assessment was based on the previous publication.
Trial registration
Not reported