The Spiesser Study: Results at 8 Years.

Abstract

Introduction. The Spiesser study was a randomized trial comparing de novo sirolimus (SRL) and cyclosporine (CsA) in low immunologic risk kidney translant recipients. SRL-based regimen provided a better kidney graft function at 5 years. We therefore extended follow-up to 8 years. Methods. Data of all patients with a functioning graft at 5 years were retrospectively collected. In intent-to-treat analysis was performed. Quantitative values and actuarial survivals were compared using the Fisher test and the log rank test, respectively. Results. Data from 112 (55 SRL, 57 CsA) out of 119 patients were available. Between 5 and 8 years post-transplantation, SRL was withdrawn in 6 patients (2 in CsA group). Thus, 37% of SRL patients versus 46% of CsA patients were still on the allocated treatment at 8 years. Mean MDRD eGFR was higher in SRL-group than in CsA group (64.0±29.5 vs. 49.6±18.2 ml/min, p=0.012). No difference was observed for proteinuria (SRL 0.8±1.2 vs CsA 0.6±1.7 g/day, p=0.163). After 5 years, 8 ESRD (2 SRL, 6 CsA) and 5 deaths (SRL 3, CsA 2) occurred. There was no difference for graft survival (p=0.615), patient survival (p=0.724) and death-censored graft survival (p=0.721). De novo DSA were observed in 17 patients, without any difference between SRL- and CsA groups (p=0.520). No differences were observed for incidence of solid and/or cutaneous cancer. Conclusion. At 8 years post-transplantation, renal function remains better in SRL-patients without increase de novo donor specific anti-HLA immunization. DISCLOSURES:Lebranchu, Y.: Grant/Research Support, Roche Laboratory funded this extension study.