Early Conversion From Calcineurin Inhibitor‐ to Everolimus‐Based Therapy Following Kidney Transplantation: Results of the Randomized ELEVATE Trial. Issue 7 (14th February 2017)

• Record Type: Journal Article
• Authors: de Fijter, J. W.; Holdaas, H.; Øyen, O.; Sanders, J.‐S.; Sundar, S.; Bemelman, F. J.; Sommerer, C.; Pascual, J.; Avihingsanon, Y.; Pongskul, C.; Oppenheimer, F.; Toselli, L.; Russ, G.; Wang, Z.; Lopez, P.; Kochuparampil, J.; Cruzado, J. M.; van der Giet, M.
• Other Names: Gaite Luis E investigator.; Lopez Vicente F investigator.; Maldonado Rafael investigator.; Massari Pablo investigator.; Novoa Pablo investigator.; Palti Gustavo investigator.; Chadban Steve investigator.; Kanellis John investigator.; Masterson Rosemary investigator.; Oberbauer Rainer investigator.; Saemann Marcus investigator.; Kuypers Dirk investigator.; Lohmus Alexsander investigator.; Cassuto Elisabeth investigator.; Frimat Luc investigator.; Lebranchu Yvon investigator.; Le Meur Yannick investigator.; Rostaing Lionel investigator.; Hauser A investigator.; Muehlfeld Anja investigator.; Nashan Bjorn investigator.; Suwelack Barbara investigator.; Weithofer Peter investigator.; Witzke Oliver investigator.; Zeier Martin investigator.; Apostolou Th. investigator.; Boletis Ioannis investigator.; Gourmenos Dimitros investigator.; Jasuja Sanjiv investigator.; Khullar Dinesh investigator.; Ravishankar Machiraju Sai investigator.; Sharma R K investigator.; Garosi Guido investigator.; Rigotti Paolo investigator.; Tisone Giuseppe investigator.; Todeschini Paola investigator.; Acevedo Reyes investigator.; Rozentais Rafalis investigator.; Juarez Federico J investigator.; Mier Gustavo Martinez investigator.; Urrea Mancilla investigator.; Machado Dominigos investigator.; Nolasco Fernando investigator.; Sampaio Susana investigator.; Dubanova A investigator.; Lucan Mihai investigator.; Kolsanov Alexander V investigator.; Medvedev Vladimir L investigator.; Moysyuk Yan G investigator.; Nesterenko V investigator.; Perlin Dmitry V investigator.; Ulyankina Irina V investigator.; Zagainov E investigator.; Dalmau Alex investigator.; Hernandez Domingo investigator.; Millan San investigator.; Avhingsanon Yingyos investigator.; Turkmen Aydin investigator.; Tuncer Murat investigator.; Yildiz Alaattin investigator.;
• Is Part Of: American journal of transplantation. Volume 17:Issue 7(2017)
• Page Start: 1853
• Page End: 1867
• Publication Date: 2017-02-14
• Subjects: clinical research/practice -- immunosuppression/immune modulation -- kidney transplantation/nephrology -- immunosuppressant -- mechanistic target of rapamycin: everolimus -- immunosuppressant -- calcineurin inhibitor (CNI) -- cardiovascular disease -- kidney (allograft) function/dysfunction -- clinical trial; Transplantation of organs, tissues, etc -- Periodicals; 617.95
• DOI: 10.1111/ajt.14186
• Languages: English
• ISSNs: 1600-6135

Abstract

Abstract : In a 24‐month, multicenter, open‐label, randomized trial, 715 de novo kidney transplant recipients were randomized at 10–14 weeks to convert to everolimus (n = 359) or remain on standard calcineurin inhibitor (CNI) therapy (n = 356; 231 tacrolimus; 125 cyclosporine), all with mycophenolic acid and steroids. The primary endpoint, change in estimated glomerular filtration rate (eGFR) from randomization to month 12, was similar for everolimus versus CNI: mean (standard error) 0.3(1.5) mL/min/1.73 2 versus −1.5(1.5) mL/min/1.73 2 (p = 0.116). Biopsy‐proven acute rejection (BPAR) at month 12 was more frequent under everolimus versus CNI overall (9.7% vs. 4.8%, p = 0.014) and versus tacrolimus‐treated patients (2.6%, p < 0.001) but similar to cyclosporine‐treated patients (8.8%, p = 0.755). Reporting on de novo donor‐specific antibodies (DSA) was limited but suggested more frequent anti‐HLA Class I DSA under everolimus. Change in left ventricular mass index was similar. Discontinuation due to adverse events was more frequent with everolimus (23.6%) versus CNI (8.4%). In conclusion, conversion to everolimus at 10–14 weeks posttransplant was associated with renal function similar to that with standard therapy overall. Rates of BPAR were low in all groups, but lower with tacrolimus than everolimus. Abstract : In a multicenter, open‐label, randomized trial of de novo kidney transplant recipients, conversion to everolimus at 10–14 weeks posttransplant is associated with similar renal function as in patients who continue to standard tacrolimus or cyclosporine therapy, with low rates of biopsy‐proven acute rejection in all groups, but lower rates with tacrolimus than everolimus.