{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,27]],"date-time":"2026-09-27T04:10:54Z","timestamp":1790482254537,"version":"4.1.0"},"reference-count":29,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2015,8,6]],"date-time":"2015-08-06T00:00:00Z","timestamp":1438819200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100015217","name":"Veloxis Pharmaceuticals","doi-asserted-by":"crossref","id":[{"id":"10.13039\/100015217","id-type":"DOI","asserted-by":"crossref"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Clinical Transplantation"],"published-print":{"date-parts":[[2015,9]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Tremor is a common side effect of tacrolimus correlated with peak\u2010dose drug concentration. <jats:styled-content style=\"fixed-case\">LCPT<\/jats:styled-content>, a novel, once\u2010daily, extended\u2010release formulation of tacrolimus, has a reduced <jats:italic><jats:styled-content style=\"fixed-case\">C<\/jats:styled-content><\/jats:italic><jats:sub>max<\/jats:sub> with comparable <jats:styled-content style=\"fixed-case\">AUC<\/jats:styled-content> exposure, requiring a ~30% dose reduction vs. immediate\u2010release tacrolimus. In this <jats:styled-content style=\"fixed-case\">p<\/jats:styled-content>hase 3b study, kidney transplant recipients (<jats:styled-content style=\"fixed-case\">KTR<\/jats:styled-content>) on a stable dose of tacrolimus and with a reported clinically significant tremor were offered a switch to <jats:styled-content style=\"fixed-case\">LCPT<\/jats:styled-content>. Tremor pre\u2010 and seven\u00a0d post\u2010conversion was evaluated by independent, blinded movement disorder neurologists using the <jats:styled-content style=\"fixed-case\">F<\/jats:styled-content>ahn\u2013<jats:styled-content style=\"fixed-case\">T<\/jats:styled-content>olosa\u2013<jats:styled-content style=\"fixed-case\">M<\/jats:styled-content>arin (<jats:styled-content style=\"fixed-case\">FTM<\/jats:styled-content>) scale and by an accelerometry device; patients completed the <jats:styled-content style=\"fixed-case\">QUEST<\/jats:styled-content> (quality of life in essential tremor) and the <jats:styled-content style=\"fixed-case\">P<\/jats:styled-content>atient <jats:styled-content style=\"fixed-case\">G<\/jats:styled-content>lobal <jats:styled-content style=\"fixed-case\">I<\/jats:styled-content>mpression of <jats:styled-content style=\"fixed-case\">C<\/jats:styled-content>hange. There were 38 patients in the m<jats:styled-content style=\"fixed-case\">ITT<\/jats:styled-content> population. A statistically and clinically significant improvement in tremor (<jats:styled-content style=\"fixed-case\">FTM<\/jats:styled-content> score, amplitude as measured by the accelerometry device and <jats:styled-content style=\"fixed-case\">QOL<\/jats:styled-content> [p\u2010values\u00a0&lt;\u00a00.05]) resulted post\u2010conversion. Change in <jats:styled-content style=\"fixed-case\">QUEST<\/jats:styled-content> was significantly (p\u00a0=\u00a00.006) correlated (<jats:italic>R<\/jats:italic>\u00a0=\u00a00.44) with change in <jats:styled-content style=\"fixed-case\">FTM<\/jats:styled-content>; 78.9% of patients reported an improvement after switching to <jats:styled-content style=\"fixed-case\">LCPT<\/jats:styled-content> (p\u00a0&lt;\u00a00.0005). To our knowledge this is the first trial in <jats:styled-content style=\"fixed-case\">KTR<\/jats:styled-content> that utilizes a sophisticated and reproducible measurement of tremor. Results suggest <jats:styled-content style=\"fixed-case\">LCPT<\/jats:styled-content> is associated with clinically meaningful improvement of hand tremor and may be an alternative management approach in lieu of further dose reduction of immediate\u2010release tacrolimus for patients experiencing tremor.<\/jats:p>","DOI":"10.1111\/ctr.12581","type":"journal-article","created":{"date-parts":[[2015,6,26]],"date-time":"2015-06-26T08:32:50Z","timestamp":1435307570000},"page":"796-805","source":"Crossref","is-referenced-by-count":115,"title":["Switching <scp>ST<\/scp>udy of Kidney TRansplant <scp>PA<\/scp>tients with Tremor to <scp>LCP<\/scp>\u2010TacrO (<scp>STRATO<\/scp>): an open\u2010label, multicenter, prospective phase 3b study"],"prefix":"10.1111","volume":"29","author":[{"given":"Anthony","family":"Langone","sequence":"first","affiliation":[{"name":"Vanderbilt University Medical Center Nashville TN USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven M.","family":"Steinberg","sequence":"additional","affiliation":[{"name":"California Institute of Renal Research San Diego CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Roberto","family":"Gedaly","sequence":"additional","affiliation":[{"name":"University of Kentucky Medical Center Lexington KY USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Laurence K.","family":"Chan","sequence":"additional","affiliation":[{"name":"University of Colorado Denver Aurora CO USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tariq","family":"Shah","sequence":"additional","affiliation":[{"name":"Transplant Research Institute Los Angeles CA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kapil D.","family":"Sethi","sequence":"additional","affiliation":[{"name":"Georgia Regents University Augusta GA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vincenza","family":"Nigro","sequence":"additional","affiliation":[{"name":"Veloxis Pharmaceuticals Edison NJ USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John C.","family":"Morgan","sequence":"additional","affiliation":[{"name":"Georgia Regents University Augusta GA USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"STRATO Investigators","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2015,8,6]]},"reference":[{"key":"e_1_2_7_2_1","volume-title":"OPTN\/SRTR 2012 Annual Data Report","author":"Organ Procurement and Transplantation Network (OPTN) and Scientific Registry of Transplant Recipients (SRTR)","year":"2014"},{"issue":"4","key":"e_1_2_7_3_1","first-page":"Art. 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