{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,2,12]],"date-time":"2026-02-12T09:40:10Z","timestamp":1770889210855,"version":"3.50.1"},"reference-count":38,"publisher":"Wiley","issue":"10","license":[{"start":{"date-parts":[[2021,9,23]],"date-time":"2021-09-23T00:00:00Z","timestamp":1632355200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Clinical Transplantation"],"published-print":{"date-parts":[[2021,10]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>We analyzed the efficacy and safety of an everolimus with reduced\u2010exposure calcineurin inhibitor (EVR+rCNI) versus mycophenolic acid with standard\u2010exposure CNI (MPA+sCNI) regimen in Asian patients from the TRANSFORM study.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>In this 24\u2010month, open\u2010label study, de novo kidney transplant recipients (KTxRs) were randomized (1:1) to receive EVR+rCNI or MPA+sCNI, along with induction therapy and corticosteroids.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of the 2037 patients randomized in the TRANSFORM study, 293 were Asian (EVR+rCNI, <jats:italic>N<\/jats:italic>\u00a0=\u00a0136; MPA+sCNI, <jats:italic>N<\/jats:italic>\u00a0=\u00a0157). At month 24, EVR+rCNI was noninferior to MPA+sCNI for the binary endpoint of estimated glomerular filtration rate (eGFR)\u00a0&lt;\u00a050\u00a0ml\/min\/1.73 m<jats:sup>2<\/jats:sup> or treated biopsy\u2010proven acute rejection (27.0%\u00a0vs. 29.2%, <jats:italic>P\u00a0=\u00a0<\/jats:italic>.011 for a noninferiority margin of 10%). Graft loss and death were reported for one patient each in both arms. Mean eGFR was higher in EVR+rCNI versus MPA+sCNI (72.2\u00a0vs. 66.3\u00a0ml\/min\/1.73 m<jats:sup>2<\/jats:sup>, <jats:italic>P\u00a0=\u00a0<\/jats:italic>.0414) even after adjusting for donor type and donor age (64.3\u00a0vs. 59.3\u00a0ml\/min\/1.73 m<jats:sup>2<\/jats:sup>, <jats:italic>P\u00a0<\/jats:italic>=\u00a0.0582). Overall incidence of adverse events was comparable. BK virus (4.4%\u00a0vs. 12.1%) and cytomegalovirus (4.4%\u00a0vs. 13.4%) infections were significantly lower in the EVR+rCNI arm.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>This subgroup analysis in Asian de novo KTxRs demonstrated that the EVR+rCNI versus MPA+sCNI regimen provides comparable antirejection efficacy, better renal function, and reduced viral infections (NCT01950819).<\/jats:p><\/jats:sec>","DOI":"10.1111\/ctr.14415","type":"journal-article","created":{"date-parts":[[2021,7,3]],"date-time":"2021-07-03T12:50:44Z","timestamp":1625316644000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["Everolimus\u2010facilitated calcineurin inhibitor reduction in Asian de novo kidney transplant recipients: 2\u2010year results from the subgroup analysis of the TRANSFORM study"],"prefix":"10.1111","volume":"35","author":[{"given":"Yoshihiko","family":"Watarai","sequence":"first","affiliation":[{"name":"Department of Transplant Surgery, Kidney Disease Center Nagoya Daini Red Cross Hospital  Nagoya Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Romina","family":"Danguilan","sequence":"additional","affiliation":[{"name":"Department of Adult Nephrology National Kidney and Transplant Institute  Quezon City Philippines"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Concesa","family":"Casasola","sequence":"additional","affiliation":[{"name":"Department of Adult Nephrology National Kidney and Transplant Institute  Quezon City Philippines"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shen\u2010Shin","family":"Chang","sequence":"additional","affiliation":[{"name":"Department of Surgery National Cheng Kung University College of Medicine and Hospital  Tainan Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5123-5964","authenticated-orcid":false,"given":"Prajej","family":"Ruangkanchanasetr","sequence":"additional","affiliation":[{"name":"Department of Medicine Phramongkutklao Hospital  Bangkok Thailand"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5250-855X","authenticated-orcid":false,"given":"Terence","family":"Kee","sequence":"additional","affiliation":[{"name":"Department of Renal Medicine Singapore General Hospital  Singapore Singapore"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Hin Seng","family":"Wong","sequence":"additional","affiliation":[{"name":"Department of Nephrology &amp; Clinical Research Centre Hospital Selayang Selangor Darul Ehsan  Batu Caves Malaysia"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Takashi","family":"Kenmochi","sequence":"additional","affiliation":[{"name":"Department of Transplant Surgery Fujita Health University Hospital  Toyoake Japan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Angel Joaquin","family":"Amante","sequence":"additional","affiliation":[{"name":"Department of Adult Nephrology National Kidney and Transplant Institute  Quezon City Philippines"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kuo\u2010Hsiung","family":"Shu","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Taichung Veterans General Hospital  Taichung Taiwan"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Atiporn","family":"Ingsathit","sequence":"additional","affiliation":[{"name":"Department of Clinical Epidemiology and Biostatistics Faculty of Medicine, Ramathibodi Hospital Mahidol University  Bangkok Thailand"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"Bernhardt","sequence":"additional","affiliation":[{"name":"Department of Research and Development Novartis Pharma AG  Basel Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Maria Pilar","family":"Hernandez\u2010Gutierrez","sequence":"additional","affiliation":[{"name":"Department of Research and Development Novartis Pharma AG  Basel Switzerland"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0990-6824","authenticated-orcid":false,"given":"Duck Jong","family":"Han","sequence":"additional","affiliation":[{"name":"Department of General Surgery Asan Medical Center  Seoul Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Myoung Soo","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Surgery Yonsei University College of Medicine  Seoul Republic of Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2021,9,23]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1111\/nep.12821"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(13)60687-X"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12882-018-1145-5"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.aju.2011.11.001"},{"key":"e_1_2_10_6_1","doi-asserted-by":"publisher","DOI":"10.1111\/ajt.15274"},{"key":"e_1_2_10_7_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-6143.2011.03504.x"},{"key":"e_1_2_10_8_1","doi-asserted-by":"publisher","DOI":"10.1093\/ckj\/sfx122"},{"key":"e_1_2_10_9_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.qco.0000172698.52408.be"},{"key":"e_1_2_10_10_1","doi-asserted-by":"publisher","DOI":"10.1038\/17401"},{"key":"e_1_2_10_11_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.TP.0000081399.75231.3B"},{"key":"e_1_2_10_12_1","doi-asserted-by":"publisher","DOI":"10.1159\/000495081"},{"key":"e_1_2_10_13_1","doi-asserted-by":"publisher","DOI":"10.1053\/j.ajkd.2010.10.054"},{"key":"e_1_2_10_14_1","doi-asserted-by":"publisher","DOI":"10.1097\/TP.0b013e3182692b70"},{"key":"e_1_2_10_15_1","doi-asserted-by":"publisher","DOI":"10.1185\/03007995.2013.855189"},{"key":"e_1_2_10_16_1","doi-asserted-by":"publisher","DOI":"10.1097\/00007890-199707150-00007"},{"key":"e_1_2_10_17_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1432-2277.2010.01140.x"},{"key":"e_1_2_10_18_1","doi-asserted-by":"publisher","DOI":"10.1097\/TP.0b013e318242be28"},{"key":"e_1_2_10_19_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa022171"},{"key":"e_1_2_10_20_1","doi-asserted-by":"publisher","DOI":"10.2217\/fon.14.264"},{"key":"e_1_2_10_21_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1109653"},{"key":"e_1_2_10_22_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-6143.2011.03674.x"},{"key":"e_1_2_10_23_1","doi-asserted-by":"publisher","DOI":"10.1111\/ajt.13327"},{"key":"e_1_2_10_24_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-6143.2010.03129.x"},{"key":"e_1_2_10_25_1","doi-asserted-by":"publisher","DOI":"10.1097\/TP.0b013e3182848e03"},{"key":"e_1_2_10_26_1","doi-asserted-by":"publisher","DOI":"10.1111\/ajt.14090"},{"key":"e_1_2_10_27_1","doi-asserted-by":"publisher","DOI":"10.1186\/2047-1440-2-14"},{"key":"e_1_2_10_28_1","doi-asserted-by":"publisher","DOI":"10.2147\/OAJCT.S63058"},{"key":"e_1_2_10_29_1","doi-asserted-by":"publisher","DOI":"10.1681\/ASN.2018010009"},{"key":"e_1_2_10_30_1","doi-asserted-by":"publisher","DOI":"10.1111\/ajt.15480"},{"key":"e_1_2_10_31_1","doi-asserted-by":"publisher","DOI":"10.1681\/ASN.2004100824"},{"key":"e_1_2_10_32_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.intimp.2016.07.019"},{"key":"e_1_2_10_33_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-6143.2011.03961.x"},{"key":"e_1_2_10_34_1","doi-asserted-by":"publisher","DOI":"10.1111\/ctr.12127"},{"key":"e_1_2_10_35_1","doi-asserted-by":"publisher","DOI":"10.1111\/ajt.14186"},{"key":"e_1_2_10_36_1","doi-asserted-by":"publisher","DOI":"10.1111\/ctr.12418"},{"key":"e_1_2_10_37_1","doi-asserted-by":"publisher","DOI":"10.1097\/01.tp.0000543467.42057.83"},{"key":"e_1_2_10_38_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.transproceed.2019.03.019"},{"key":"e_1_2_10_39_1","volume-title":"CERTICAN\/ZORTRESS [Prescribing Information]","year":"2018"}],"container-title":["Clinical Transplantation"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/ctr.14415","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/full-xml\/10.1111\/ctr.14415","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/pdf\/10.1111\/ctr.14415","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,8,25]],"date-time":"2023-08-25T17:35:56Z","timestamp":1692984956000},"score":1,"resource":{"primary":{"URL":"https:\/\/onlinelibrary.wiley.com\/doi\/10.1111\/ctr.14415"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,9,23]]},"references-count":38,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2021,10]]}},"alternative-id":["10.1111\/ctr.14415"],"URL":"https:\/\/doi.org\/10.1111\/ctr.14415","archive":["Portico"],"relation":{},"ISSN":["0902-0063","1399-0012"],"issn-type":[{"value":"0902-0063","type":"print"},{"value":"1399-0012","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,9,23]]},"assertion":[{"value":"2021-02-24","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-06-25","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2021-09-23","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e14415"}}