Eight-year results of the Spiesser study, a randomized trial comparing de novo sirolimus and cyclosporine in renal transplantation.
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 Importantly, no detrimental impact was observed in patients in whom sirolimus has been withdrawn (eGFR = 49.5 ml/min).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.
Service de Néphrologie et Immunologie clinique, CHRU de Tours, Tours, France.|Université François-Rabelais de Tours, Tours, France.
Philippe
P
Gatault
Service de Néphrologie, CHU de Rouen, Rouen, France.
Dominique
D
Bertrand
Service de Néphrologie et Immunologie clinique, CHRU de Tours, Tours, France.|Université François-Rabelais de Tours, Tours, France.
Matthias
M
Büchler
Service de Transplantation rénale, CHU de Reims, Reims, France.
Charlotte
C
Colosio
Service de Néphrologie et Transplantation rénale, CHU de Caen, Caen, France.
Bruno
B
Hurault de Ligny
Service de Néphrologie et Dialyse, CHU d'Amiens, Amiens, France.
Pierre-François
PF
Weestel
Service de Néphrologie et Transplantation rénale, CHU de Limoges, Limoges, France.
Jean-Philippe
JP
Rerolle
Service de Néphrologie, CHU de Poitiers, Poitiers, France.
Antoine
A
Thierry
Service de Néphrologie-Dialyse-Transplantation, CHU d'Angers, Angers, France.
Johnny
J
Sayegh
Service de Néphrologie et Transplantation rénale, CHRU de Strasbourg, Strasbourg, France.
Bruno
B
Moulin
Service de Transplantation rénale, AP-HP, Hôpital de Necker Enfants-Malades, Paris, France.
Renaud
R
Snanoudj
Service de Néphrologie, CHU de Rennes, Rennes, France.
Joseph
J
Rivalan
Service de Néphrologie et Transplantation rénale, CHU de Clermont-Ferrand, Clermont-Ferrand, France.
Anne-Elisabeth
AE
Heng
Service de Néphrologie et Immunologie clinique, CHRU de Tours, Tours, France.
Bénédicte
B
Sautenet
Service de Néphrologie et Immunologie clinique, CHRU de Tours, Tours, France.|Université François-Rabelais de Tours, Tours, France.
Yvon
Y
Lebranchu
D000328:Adult; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000704:Analysis of Variance; D002423:Cause of Death; D016572:Cyclosporine / Q000008:administration & dosage; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005500:Follow-Up Studies; D006084:Graft Rejection; D006085:Graft Survival; D007165:Immunosuppression Therapy / Q000379:methods; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D053208:Kaplan-Meier Estimate; D016030:Kidney Transplantation / Q000009:adverse effects / Q000379:methods / Q000401:mortality; D011446:Prospective Studies; D018570:Risk Assessment; D020123:Sirolimus / Q000008:administration & dosage; D018709:Statistics, Nonparametric; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome
D016572:Cyclosporine; D007166:Immunosuppressive Agents; D020123:Sirolimus
clinical trial; human leukocyte antigen-antibody posttransplantation; immunosuppression; kidney transplantation; target of rapamycin-inhibitors