Eight-year results of the Spiesser study, a randomized trial comparingde novosirolimus and cyclosporine in renal transplantation

• DOI: 10.1111/tri.12656
• Publication Date: 2015-08-18T17:21:06Z
• Authors: Philippe Gatault; Dominique Bertrand; Matthias Büchler; Charlotte Colosio; Bruno Hurault de ...; Pierre-François W...; Jean-Philippe Rer...; Antoine Thierry; Johnny Sayegh; Bruno Moulin; Renaud Snanoudj; Joseph Rivalan; Anne-Elisabeth Heng; Bénédicte Sautenet; Yvon Lebranchu
• Keywords: Adult; Graft Rejection; Male; Time Factors; [SDV]Life Sciences [q-bio]; 610; kidney transplantation; Kaplan-Meier Estimate; Risk Assessment; Drug Administration Schedule; Dose-Response Relationship; 03 medical and health sciences; 0302 clinical medicine; target of rapamycin-inhibitors; Cause of Death; 617; Humans; Nonparametric; Prospective Studies; Immunosuppression Therapy; Sirolimus; Transplantation; Analysis of Variance; immunosuppression; Dose-Response Relationship, Drug; Statistics; Graft Survival; clinical trial; human leukocyte antigen-antibody posttransplantation; Middle Aged; Kidney Transplantation; 3. Good health; [SDV] Life Sciences [q-bio]; Survival Rate; Treatment Outcome; Cyclosporine; Female; Drug; Immunosuppression; Immunosuppressive Agents; Follow-Up Studies

We present the results at 8 years 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 ± 27.3 ml/min vs. 47.8 ± 17.1 ml/min, P = 0.004), in particular because graft function was excellent in patients maintained under sirolimus (eGFR = 74.0 ml/min). Importantly, no detrimental impact was observed in patients in whom sirolimus has been withdrawn (eGFR = 49.5 ml/min).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.