{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,11]],"date-time":"2026-05-11T13:25:02Z","timestamp":1778505902518,"version":"3.51.4"},"reference-count":13,"publisher":"Wiley","issue":"6","license":[{"start":{"date-parts":[[2016,5,10]],"date-time":"2016-05-10T00:00:00Z","timestamp":1462838400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"DOI":"10.13039\/100008792","name":"Novartis Pharma","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008792","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Clinical Transplantation"],"published-print":{"date-parts":[[2016,6]]},"abstract":"Abstract<\/jats:title>Background<\/jats:title>The 12\u2010month (M) PROTECT<\/jats:styled-content> study showed that de novo<\/jats:italic> liver transplant recipients (LT<\/jats:styled-content>xR) who switched from a calcineurin inhibitor (CNI<\/jats:styled-content>)\u2010based immunosuppression to a CNI<\/jats:styled-content>\u2010free everolimus (EVR<\/jats:styled-content>)\u2010based regimen showed numerically better renal function. Here, we present the five\u2010yr follow\u2010up data.<\/jats:p><\/jats:sec>Methods<\/jats:title>PROTECT<\/jats:styled-content> was a randomized controlled study in which LT<\/jats:styled-content>xR received basiliximab and CNI<\/jats:styled-content>\u2010based immunosuppression \u00b1 corticosteroids. Patients were randomized 1:1 to receive EVR<\/jats:styled-content> or continue CNI<\/jats:styled-content>. Patients completing the core study could enter the extension study on their randomized treatment.<\/jats:p><\/jats:sec>Results<\/jats:title>A total of 81 patients entered the extension study (41, EVR<\/jats:styled-content>; 40, CNI<\/jats:styled-content>). At M59 post\u2010randomization, the adjusted mean eGFR<\/jats:styled-content> was significantly higher in the EVR<\/jats:styled-content> group, with a benefit of 12.4 mL\/min using Cockcroft\u2013Gault (95% CI<\/jats:styled-content>: 1.2; 23.6; p = 0.0301). Also, there was a significant benefit for adjusted and unadjusted eGFR<\/jats:styled-content> using the four\u2010variable Modification of Diet in Renal Disease (MDRD<\/jats:styled-content>4) or Nankivell formula. During the extension period, treatment failure rates were similar. SAE<\/jats:styled-content>s occurred in 26 (63.4%) and 28 (70.0%) of the patients in EVR<\/jats:styled-content> and CNI<\/jats:styled-content> groups, respectively.<\/jats:p><\/jats:sec>Conclusion<\/jats:title>Compared with the CNI<\/jats:styled-content>\u2010based treatment, EVR<\/jats:styled-content>\u2010based CNI<\/jats:styled-content>\u2010free immunosuppression resulted in significantly better renal function and comparable patient and graft outcomes after five\u2010yr follow\u2010up.<\/jats:p><\/jats:sec>","DOI":"10.1111\/ctr.12744","type":"journal-article","created":{"date-parts":[[2016,5,10]],"date-time":"2016-05-10T09:11:40Z","timestamp":1462871500000},"page":"741-748","source":"Crossref","is-referenced-by-count":40,"title":["Long\u2010term follow\u2010up of five yr shows superior renal function with everolimus plus early calcineurin inhibitor withdrawal in the PROTECT<\/scp> randomized liver transplantation study"],"prefix":"10.1111","volume":"30","author":[{"given":"Martina","family":"Sterneck","sequence":"first","affiliation":[{"name":"Department of Medicine University Medical Center Hamburg\u2010Eppendorf Hamburg Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gernot M.","family":"Kaiser","sequence":"additional","affiliation":[{"name":"Department of General, Visceral and Transplantation Surgery Essen University Hospital Essen Germany"},{"name":"Department of General and Visceral Surgery St. Bernhard\u2010Hospital Kamp\u2010Lintfort Kamp\u2010Lintfort Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nils","family":"Heyne","sequence":"additional","affiliation":[{"name":"Department of General, Visceral and Transplant Surgery University Hospital Tuebingen Tuebingen Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Nicolas","family":"Richter","sequence":"additional","affiliation":[{"name":"Clinic for General, Abdominal and Transplant Surgery Hannover Medical School (MHH) Hannover Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Falk","family":"Rauchfuss","sequence":"additional","affiliation":[{"name":"Department of General, Abdominal and Vascular Surgery Jena University Hospital Jena Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andreas","family":"Pascher","sequence":"additional","affiliation":[{"name":"Clinic for General, Abdominal and Transplant Surgery Charit\u00e9 University Medical Center Berlin Berlin Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"Schemmer","sequence":"additional","affiliation":[{"name":"Department of General, Visceral and Transplant Surgery University Hospital Heidelberg Heidelberg Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Lutz","family":"Fischer","sequence":"additional","affiliation":[{"name":"Department of Medicine University Medical Center Hamburg\u2010Eppendorf Hamburg Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Christian G.","family":"Klein","sequence":"additional","affiliation":[{"name":"Department of General, Visceral and Transplantation Surgery Essen University Hospital Essen Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Silvio","family":"Nadalin","sequence":"additional","affiliation":[{"name":"Department of General, Visceral and Transplant Surgery University Hospital Tuebingen Tuebingen Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Frank","family":"Lehner","sequence":"additional","affiliation":[{"name":"Clinic for General, Abdominal and Transplant Surgery Hannover Medical School (MHH) Hannover Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Utz","family":"Settmacher","sequence":"additional","affiliation":[{"name":"Department of General, Abdominal and Vascular Surgery Jena University Hospital Jena Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Daniel","family":"Gotthardt","sequence":"additional","affiliation":[{"name":"Department of General, Visceral and Transplant Surgery University Hospital Heidelberg Heidelberg Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martin","family":"Loss","sequence":"additional","affiliation":[{"name":"Department of Surgery University Hospital Regensburg Regensburg Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Stephan","family":"Ladenburger","sequence":"additional","affiliation":[{"name":"Novartis Pharma GmbH N\u00fcrnberg Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"Wimmer","sequence":"additional","affiliation":[{"name":"Novartis Pharma GmbH N\u00fcrnberg Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Markus","family":"Dworak","sequence":"additional","affiliation":[{"name":"Novartis Pharma GmbH N\u00fcrnberg Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hans J.","family":"Schlitt","sequence":"additional","affiliation":[{"name":"Department of Surgery University Hospital Regensburg Regensburg Germany"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2016,5,10]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.lts.2003.09.018"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa021744"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1002\/lt.21821"},{"key":"e_1_2_9_5_1","first-page":"356","article-title":"The side\u2010effects of ciclosporine\u2010A and tacrolimus","volume":"49","author":"Mihatsch MJ","year":"1998","journal-title":"Clin Nephrol"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.TP.0000128636.70499.6E"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-6143.2012.04212.x"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1111\/ajt.12280"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-6143.2012.04049.x"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1111\/ajt.12615"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-130-6-199903160-00002"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.1097\/00007890-199506270-00007"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1097\/TP.0b013e3182384aff"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1111\/ctr.12045"}],"container-title":["Clinical Transplantation"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.wiley.com\/onlinelibrary\/tdm\/v1\/articles\/10.1111%2Fctr.12744","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/ctr.12744","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,3]],"date-time":"2023-10-03T03:07:48Z","timestamp":1696302468000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/ctr.12744"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2016,5,10]]},"references-count":13,"journal-issue":{"issue":"6","published-print":{"date-parts":[[2016,6]]}},"alternative-id":["10.1111\/ctr.12744"],"URL":"https:\/\/doi.org\/10.1111\/ctr.12744","archive":["Portico"],"relation":{},"ISSN":["0902-0063","1399-0012"],"issn-type":[{"value":"0902-0063","type":"print"},{"value":"1399-0012","type":"electronic"}],"subject":[],"published":{"date-parts":[[2016,5,10]]}}}