Eight-year results of the Spiesser study, a randomized trial comparing de novo sirolimus and cyclosporine in renal transplantation.
Gatault P, Bertrand D, et al.Transplant International 2015 [record in progress]
Aims
An extension of the Spiesser study to report on outcomes 8 years after kidney transplantation with sirolimus and cyclosporin treatment.
Interventions
Patients received either a sirolimus-MMF–based regimen (sirolimus group) or cyclosporine-MMF–based regimen (cyclosporin group).
Participants
150 kidney transplant recipients aged 18-65 years
Outcomes
The primary outcomes measured were estimated glomerular filtration rate (eGFR), graft and patient survival, and risk of de novo donor-specific antibody (DSA) appearance. Other outcomes were graft failure and death, serum creatinine level, proteinuria, immunosuppressive regimen, systolic and diastolic arterial pressure, antihypertensive drugs, hemoglobinemia level, erythropoietin use, post-transplant diabetes mellitus (PTDM) and malignancies.
Follow-up
8 years
CET Conclusions
In this 8 year follow up of a trial comparing de novo sirolimus and cyclosporine in low risk recipients of a renal transplant there was no difference in patient or graft survival but a significant better renal function in the de novo sirolimus group compared to the cyclosporine group. However it should be noted that the analysis only dealt with patients who had a functioning graft at 8 years. Furthermore there was no difference between the groups in the incidence of de novo DSAs. Two earlier reports of the trial have documented the high withdrawal rate in the sirolimus group. Never the less it does appear that patients who can tolerate sirolimus are likely to have better renal function in the long term than patients maintained on cyclosporine.
Data analysis
Strict intention-to-treat analysis
Quality notes
Score based on 'Büchler M, 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.'
Trial registration
None