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Five-year results of a randomized trial comparing de novo sirolimus and cyclosporine in renal transplantation: the SPIESSER study.

Yvon Lebranchu 1 R. Snanoudj 2 Olivier Toupance 3 P.-F. Weestel 4, 5 B. Hurault de Ligny 6 M. Buchler 1 Jean-Philippe Rerolle 7 A. Thierry 8 B. Moulin 9 Jean-François Subra 10 P. Deteix 11 P. Le Pogamp 12 L. Finzi 13 I. Etienne 14
1 Service de néphrologie et immunologie clinique
2 Service de néphrologie adultes [CHU Necker]
3 service de néphrologie et transplantation
4 Service de dyalise et transplantation
5 Affectations Mineralisantes du Systeme Cardiovasculaire : Calcifications Arterielles et Valvulaires Aortiques
6 Service de Néphrologie-Dialyse-Transplantation rénale [CHU Caen]
7 Service de Pédiatrie médicale - Spécialités médicales [CHU Limoges]
8 Service de néphrologie - hémodialyse et transplantation rénale
9 Service de néphrologie et transplantation rénale
10 Service de Néphrologie [Angers]
11 Service de néphrologie
12 Service de néphrologie
13 ClinSearch
14 Service de Néphrologie [Rouen]
Abstract : Calcineurin inhibitors improve acute rejection rates and short-term graft survival in renal transplantation, but their continuous use may be deleterious. We evaluated the 5-year outcomes of sirolimus (SRL) versus cyclosporine (CsA) immunosuppressive treatment. This observational study was an extension of the SPIESSER study where deceased donor kidney transplant recipients were randomized before transplantation to a SRL- or CsA-based regimen and followed up 1 year. Data from 131 (63 SRL, 68 CsA) out of 133 patients living with a functional graft at 1 year were collected retrospectively at 5 years posttransplant. Seventy percent of CsA patients versus 54% of SRL patients were still on the allocated treatment at 5 years (p = 0.091), most discontinuations in each group being due to safety issues. In intent-to-treat, mean MDRD eGFR was higher with SRL: 54.2 versus 45.3 mL/min with CsA (p = 0.019); SRL advantage was greater in on-treatment analyses. There were no differences for patient survival (p = 0.873), graft survival (p = 0.121) and acute rejection (p = 0.284). Adverse events were more frequent with SRL (80% vs. 60%, p = 0.015). Results confirmed the high SRL discontinuation rate due to adverse events. Nevertheless, a benefit was evidenced on renal function in patients (more than 50%) still on treatment at 5 years.
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https://www.hal.inserm.fr/inserm-00926347
Contributor : Pierre Marquet <>
Submitted on : Thursday, January 9, 2014 - 2:41:38 PM
Last modification on : Wednesday, August 19, 2020 - 11:16:41 AM

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HCL | UNIV-RENNES1 | UNIV-ANGERS | UNIV-TOURS | UNIV-RENNES | COMUE-NORMANDIE | UNIROUEN | UNAM | UNICAEN

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Yvon Lebranchu, R. Snanoudj, Olivier Toupance, P.-F. Weestel, B. Hurault de Ligny, et al.. Five-year results of a randomized trial comparing de novo sirolimus and cyclosporine in renal transplantation: the SPIESSER study.. American Journal of Transplantation, Wiley, 2012, 12 (7), pp.1801-10. ⟨10.1111/j.1600-6143.2012.04036.x⟩. ⟨inserm-00926347⟩

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