Eight-year results of the Spiesser study, a randomized trial comparing de novo sirolimus and cyclosporine in renal transplantation

We present the results at 8years of the Spiesser study, a randomized trial comparing de novo sirolimus and cyclosporine in kidney transplant recipients at low immunologic risk. We assessed estimated glomerular filtration (eGFR), graft, patient, and death-censored graft survival (log-rank compared), de novo DSA appearance, risk of malignancy, post-transplant diabetes mellitus (PTDM), and anemia. Intent-to-treat and on-treatment analyses were performed. Graft survival was similar in both groups (sirolimus: 73.3%, cyclosporine: 77.7, P=0.574). No difference was observed between treatment groups concerning patient survival (P=0.508) and death-censored graft survival (P=0.858). In conditional intent-to-treat analysis, mean eGFR was greater in sirolimus than in cyclosporine group (62.5 +/- 27.3ml/min vs. 47.8 +/- 17.1ml/min, P=0.004), in particular because graft function was excellent in patients maintained under sirolimus (eGFR=74.0ml/min). Importantly, no detrimental impact was observed in patients in whom sirolimus has been withdrawn (eGFR=49.5ml/min). Overall, 17 patients showed de novo DSAs, with no difference between the two groups (P=0.520). Malignancy did not differ by treatment. An initial maintenance regimen based on sirolimus provides a long-term improvement in renal function for kidney transplant patients, especially for those maintained on sirolimus.