Everolimus with very low-exposure cyclosporine a in de novo kidney transplantation: a multicenter, randomized, controlled trial

Transplantation
M SalvadoriClaudio Ponticelli

Abstract

In combination with everolimus (EVL), cyclosporine A (CsA) may be used at low exposure, so reducing the risk of renal dysfunction in renal transplant recipients (RTR). We evaluated whether higher exposure of EVL could allow a further reduction of CsA. De novo RTR were randomized to standard exposure EVL (C0 3-8 ng/mL) with low-concentration CsA (C2 maintenance levels 350-500 ng/mL, group A) or higher EVL exposure (C0 8-12 ng/mL) with very low-concentration CsA (C2 maintenance levels 150-300 ng/mL, group B). The primary endpoints were 6-month creatinine clearance (CrCl) and biopsy-proven acute rejection (BPAR) rate. After 6 months, patients were followed up (observational extension) to 12 months. Two hundred eighty-five RTR (97% from deceased donors) were enrolled. Two patients per group died (1.4%). The 6-month death-censored graft survival was 90.2% in group A and 97.9% in group B and was unchanged at 12 months (P=0.007). There was no significant difference between groups at 6 months in CrCl (59.9 vs. 57.8 mL/min) and BPAR rates (14.7% vs. 11.9%) and also at 12 months (CrCl 62.5+/-20.7 vs. 61.3+/-22.0 mL/min, BPAR 14.7% vs. 14.1%). No significant differences were seen in treated acute rejections, steroid-resistant acute reject...Continue Reading

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Citations

Sep 8, 2010·Intensive Care Medicine·Erica L Martin, V Marco Ranieri
Sep 18, 2010·Nephrology, Dialysis, Transplantation : Official Publication of the European Dialysis and Transplant Association - European Renal Association·Claudio PonticelliMaurizio Salvadori
Aug 2, 2013·Nephrology, Dialysis, Transplantation : Official Publication of the European Dialysis and Transplant Association - European Renal Association·Paolo CartaEnrico Eugenio Minetti
Sep 3, 2011·Current Opinion in Nephrology and Hypertension·Michael Jin Casey, Herwig-Ulf Meier-Kriesche
Sep 29, 2011·Journal of the American Society of Nephrology : JASN·Adnan SharifRichard Borrows
Oct 20, 2012·Current Opinion in Organ Transplantation·Maxime TouzotJacques Dantal
Aug 27, 2013·Expert Review of Clinical Immunology·Marialuisa Framarino-dei-MalatestaGiuseppe Tisone
Dec 17, 2015·Expert Opinion on Drug Safety·Pedro Ventura AguiarFritz Diekmann
Dec 1, 2010·Kidney International. Supplement·Josep M GrinyóJosep M Cruzado
Aug 10, 2010·Transplantation Proceedings·C Ponticelli, M P Scolari
Nov 26, 2015·Transplantation Reviews·Oliver WitzkeWolfgang Arns
Sep 4, 2015·Clinical Transplantation·Martina KochBjoern Nashan
Mar 9, 2011·Transplant International : Official Journal of the European Society for Organ Transplantation·Claudio PonticelliGiorgio Graziani
Mar 9, 2011·Liver Transplantation : Official Publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society·Faouzi SalibaJérome Dumortier
May 31, 2012·American Journal of Transplantation : Official Journal of the American Society of Transplantation and the American Society of Transplant Surgeons·K BuddeUNKNOWN ZEUS Study Investigators
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May 27, 2010·Transplant International : Official Journal of the European Society for Organ Transplantation·Jacques DantalUNKNOWN RAD A2420 Study Group
May 24, 2012·Transplant International : Official Journal of the European Society for Organ Transplantation·Claudio Ponticelli, Giorgio Graziani
Mar 19, 2016·American Journal of Transplantation : Official Journal of the American Society of Transplantation and the American Society of Transplant Surgeons·D SawinskiC A Umscheid
Mar 18, 2016·Therapeutic Drug Monitoring·Maria ShipkovaPierre Marquet
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Mar 27, 2015·Transplant International : Official Journal of the European Society for Organ Transplantation·Renaud SnanoudjChristophe Legendre
Mar 13, 2012·Expert Opinion on Pharmacotherapy·Jacques Dantal

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