{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,22]],"date-time":"2026-10-22T15:56:55Z","timestamp":1792684615647,"version":"4.5.0"},"reference-count":48,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"7","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JASN"],"published-print":{"date-parts":[[2018,7]]},"abstract":"<jats:p>\n                    <jats:bold>Background<\/jats:bold>\n                    Everolimus permits reduced calcineurin inhibitor (CNI) exposure, but the efficacy and safety outcomes of this treatment after kidney transplant require confirmation.\n                  <\/jats:p>\n                  <jats:p>\n                    <jats:bold>Methods<\/jats:bold>\n                    In a multicenter noninferiority trial, we randomized 2037\n                    <jats:italic toggle=\"yes\">de novo<\/jats:italic>\n                    kidney transplant recipients to receive, in combination with induction therapy and corticosteroids, everolimus with reduced-exposure CNI (everolimus arm) or mycophenolic acid (MPA) with standard-exposure CNI (MPA arm). The primary end point was treated biopsy-proven acute rejection or eGFR&lt;50 ml\/min per 1.73 m\n                    <jats:sup>2<\/jats:sup>\n                    at post-transplant month 12 using a 10% noninferiority margin.\n                  <\/jats:p>\n                  <jats:p>\n                    <jats:bold>Results<\/jats:bold>\n                    In the intent-to-treat population (everolimus\n                    <jats:italic toggle=\"yes\">n<\/jats:italic>\n                    =1022, MPA\n                    <jats:italic toggle=\"yes\">n<\/jats:italic>\n                    =1015), the primary end point incidence was 48.2% (493) with everolimus and 45.1% (457) with MPA (difference 3.2%; 95% confidence interval, \u22121.3% to 7.6%). Similar between-treatment differences in incidence were observed in the subgroups of patients who received tacrolimus or cyclosporine. Treated biopsy-proven acute rejection, graft loss, or death at post-transplant month 12 occurred in 14.9% and 12.5% of patients treated with everolimus and MPA, respectively (difference 2.3%; 95% confidence interval, \u22121.7% to 6.4%).\n                    <jats:italic toggle=\"yes\">De novo<\/jats:italic>\n                    donor-specific antibody incidence at 12 months and antibody-mediated rejection rate did not differ between arms. Cytomegalovirus (3.6% versus 13.3%) and BK virus infections (4.3% versus 8.0%) were less frequent in the everolimus arm than in the MPA arm. Overall, 23.0% and 11.9% of patients treated with everolimus and MPA, respectively, discontinued the study drug because of adverse events.\n                  <\/jats:p>\n                  <jats:p>\n                    <jats:bold>Conclusions<\/jats:bold>\n                    In kidney transplant recipients at mild-to-moderate immunologic risk, everolimus was noninferior to MPA for a binary composite end point assessing immunosuppressive efficacy and preservation of graft function.\n                  <\/jats:p>","DOI":"10.1681\/asn.2018010009","type":"journal-article","created":{"date-parts":[[2018,5,11]],"date-time":"2018-05-11T09:20:12Z","timestamp":1526030412000},"page":"1979-1991","source":"Crossref","is-referenced-by-count":244,"title":["Everolimus with Reduced Calcineurin Inhibitor Exposure in Renal Transplantation"],"prefix":"10.1681","volume":"29","clinical-trial-number":[{"clinical-trial-number":"nct01950819","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Julio","family":"Pascual","sequence":"first","affiliation":[{"name":"Department of Nephrology, Hospital del Mar, Barcelona, Spain;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stefan P.","family":"Berger","sequence":"additional","affiliation":[{"name":"Department of Nephrology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Oliver","family":"Witzke","sequence":"additional","affiliation":[{"name":"Department of Infectious Diseases and Department of Nephrology, University Hospital Essen, University Duisburg-Essen, Germany;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helio","family":"Tedesco","sequence":"additional","affiliation":[{"name":"Nephrology Division, Hospital do Rim, Universidade Federal de S\u00e3o Paulo (UNIFESP), S\u00e3o Paulo, Brazil;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shamkant","family":"Mulgaonkar","sequence":"additional","affiliation":[{"name":"Renal and Pancreas Division, St. Barnabas Medical Center, Livingston, New Jersey;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasir","family":"Qazi","sequence":"additional","affiliation":[{"name":"Division of Nephrology, Keck School of Medicine Renal Transplant Program, University of Southern California, Los Angeles, California;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven","family":"Chadban","sequence":"additional","affiliation":[{"name":"Department of Renal Medicine and Transplantation, Renal Medicine and Transplantation, Royal Prince Alfred Hospital, Camperdown, New South Wales, Australia;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Federico","family":"Oppenheimer","sequence":"additional","affiliation":[{"name":"Department of Nephrology and Renal Transplantation, Renal Transplant Unit, Hospital Clinic of Barcelona, Barcelona, Spain;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claudia","family":"Sommerer","sequence":"additional","affiliation":[{"name":"Department of Nephrology, Heidelberg University Hospital, Heidelberg, Germany;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rainer","family":"Oberbauer","sequence":"additional","affiliation":[{"name":"Department of Nephrology and Dialysis, University Clinic for Internal Medicine III, Medical University Vienna, Vienna, Austria;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoshihiko","family":"Watarai","sequence":"additional","affiliation":[{"name":"Department of Transplant Surgery, Nagoya Daini Red Cross Hospital, Nagoya-City, Aich, Japan;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christophe","family":"Legendre","sequence":"additional","affiliation":[{"name":"Department of Kidney Transplantation, Adult Transplantation Service, Paris Descartes University and Necker Hospital, Paris, France;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Franco","family":"Citterio","sequence":"additional","affiliation":[{"name":"Department of Surgery, Renal Transplantation, Catholic University, Rome, Italy;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mitchell","family":"Henry","sequence":"additional","affiliation":[{"name":"Department of Surgery, The Comprehensive Transplant Center, The Ohio State University, Wexner Medical Center, Columbus, Ohio;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Titte R.","family":"Srinivas","sequence":"additional","affiliation":[{"name":"Division of Nephrology, Medical University of South Carolina, Mount Pleasant, South Carolina;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Wen-Lin","family":"Luo","sequence":"additional","affiliation":[{"name":"Department of Biometrics and Statistical Science, Novartis Pharmaceuticals, East Hanover, New Jersey;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"AnaMaria","family":"Marti","sequence":"additional","affiliation":[{"name":"Department of Research and Development, Novartis Pharma AG, Basel, Switzerland; and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Peter","family":"Bernhardt","sequence":"additional","affiliation":[{"name":"Department of Research and Development, Novartis Pharma AG, Basel, Switzerland; and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Flavio","family":"Vincenti","sequence":"additional","affiliation":[{"name":"Department of Surgery, Kidney Transplant Service, University of California, San Francisco, 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