{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,30]],"date-time":"2026-10-30T13:26:56Z","timestamp":1793366816209,"version":"4.5.0"},"reference-count":48,"publisher":"Elsevier BV","issue":"4","license":[{"start":{"date-parts":[[2023,10,1]],"date-time":"2023-10-01T00:00:00Z","timestamp":1696118400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2023,10,1]],"date-time":"2023-10-01T00:00:00Z","timestamp":1696118400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"}],"content-domain":{"domain":["kidney-international.org","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Kidney International"],"published-print":{"date-parts":[[2023,10]]},"DOI":"10.1016\/j.kint.2023.06.021","type":"journal-article","created":{"date-parts":[[2023,6,28]],"date-time":"2023-06-28T20:54:40Z","timestamp":1687985680000},"page":"840-850","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":50,"title":["A prospective controlled, randomized clinical trial of kidney transplant recipients developed personalized tacrolimus dosing using model-based Bayesian Prediction"],"prefix":"10.1016","volume":"104","author":[{"given":"Nuria","family":"Lloberas","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Josep M.","family":"Griny\u00f3","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helena","family":"Colom","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Vidal-Alabr\u00f3","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1352-3084","authenticated-orcid":false,"given":"Pere","family":"Fontova","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raul","family":"Rigo-Bonnin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ariadna","family":"Padr\u00f3","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Oriol","family":"Bestard","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edoardo","family":"Melilli","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nuria","family":"Montero","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ana","family":"Coloma","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Manonelles","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria","family":"Meneghini","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alex","family":"Fav\u00e0","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joan","family":"Torras","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Josep M.","family":"Cruzado","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"key":"10.1016\/j.kint.2023.06.021_bib1","doi-asserted-by":"crossref","first-page":"e108","DOI":"10.1097\/TP.0000000000002052","article-title":"High intrapatient variability of tacrolimus exposure in the early period after liver transplantation is associated with poorer outcomes","volume":"102","author":"Rayar","year":"2018","journal-title":"Transplantation"},{"key":"10.1016\/j.kint.2023.06.021_bib2","doi-asserted-by":"crossref","first-page":"2562","DOI":"10.1056\/NEJMoa067411","article-title":"Reduced exposure to calcineurin inhibitors in renal transplantation","volume":"357","author":"Ekberg","year":"2007","journal-title":"N\u00a0Engl J Med"},{"key":"10.1016\/j.kint.2023.06.021_bib3","doi-asserted-by":"crossref","first-page":"1370","DOI":"10.1111\/ajt.14109","article-title":"Reduction of extended-release tacrolimus dose in low-immunological-risk kidney transplant recipients increases risk of rejection and appearance of donor-specific antibodies: a randomized study","volume":"17","author":"Gatault","year":"2017","journal-title":"Am J Transplant"},{"key":"10.1016\/j.kint.2023.06.021_bib4","doi-asserted-by":"crossref","first-page":"434","DOI":"10.1016\/j.clpt.2003.12.009","article-title":"Clinical efficacy and toxicity profile of tacrolimus and mycophenolic acid in relation to combined long-term pharmacokinetics in de novo renal allograft recipients","volume":"75","author":"Kuypers","year":"2004","journal-title":"Clin Pharmacol Ther"},{"key":"10.1016\/j.kint.2023.06.021_bib5","doi-asserted-by":"crossref","first-page":"296","DOI":"10.1016\/S0041-1345(98)01633-9","article-title":"Low systemic exposure to tacrolimus correlates with acute rejection","volume":"31","author":"Undre","year":"1999","journal-title":"Transplant Proc"},{"key":"10.1016\/j.kint.2023.06.021_bib6","doi-asserted-by":"crossref","first-page":"369","DOI":"10.1097\/FTD.0000000000000955","article-title":"High tacrolimus intrapatient variability and subtherapeutic immunosuppression are associated with adverse kidney transplant outcomes","volume":"44","author":"Mendoza Rojas","year":"2022","journal-title":"Ther Drug Monit"},{"key":"10.1016\/j.kint.2023.06.021_bib7","doi-asserted-by":"crossref","first-page":"2085","DOI":"10.1111\/ajt.13691","article-title":"A\u00a0randomized controlled trial comparing the efficacy of Cyp3a5 genotype-based with body-weight-based tacrolimus dosing after living donor kidney transplantation","volume":"16","author":"Shuker","year":"2016","journal-title":"Am J Transplant"},{"key":"10.1016\/j.kint.2023.06.021_bib8","doi-asserted-by":"crossref","first-page":"2796","DOI":"10.1111\/ajt.12955","article-title":"Novel once-daily extended-release tacrolimus (LCPT) versus twice-daily tacrolimus in de novo kidney transplants: one-year results of phase III, double-blind, randomized trial","volume":"14","author":"Budde","year":"2014","journal-title":"Am J Transplant"},{"key":"10.1016\/j.kint.2023.06.021_bib9","first-page":"721","article-title":"Optimization of initial tacrolimus dose using pharmacogenetic testing","volume":"87","author":"Thervet","year":"2010","journal-title":"Clin Pharmacol Ther"},{"key":"10.1016\/j.kint.2023.06.021_bib10","doi-asserted-by":"crossref","first-page":"245","DOI":"10.1016\/S0009-9236(03)00168-1","article-title":"Genetic polymorphisms of the CYP3A4, CYP3A5, and MDR-1 genes and pharmacokinetics of the calcineurin inhibitors cyclosporine and tacrolimus","volume":"74","author":"Hesselink","year":"2003","journal-title":"Clin Pharmacol Ther"},{"key":"10.1016\/j.kint.2023.06.021_bib11","doi-asserted-by":"crossref","first-page":"313","DOI":"10.1097\/FPC.0000000000000296","article-title":"The combination of CYP3A4\u221722 and CYP3A5\u22173 single-nucleotide polymorphisms determines tacrolimus dose requirement after kidney transplantation","volume":"27","author":"Lloberas","year":"2017","journal-title":"Pharmacogenet Genomics"},{"key":"10.1016\/j.kint.2023.06.021_bib12","doi-asserted-by":"crossref","first-page":"1574","DOI":"10.1373\/clinchem.2011.165613","article-title":"A\u00a0new functional CYP3A4 intron 6 polymorphism significantly affects tacrolimus pharmacokinetics in kidney transplant recipients","volume":"57","author":"Elens","year":"2011","journal-title":"Clin Chem"},{"key":"10.1016\/j.kint.2023.06.021_bib13","doi-asserted-by":"crossref","DOI":"10.3389\/fgene.2021.711943","article-title":"CYP3A4\u221722 genotyping in clinical practice: ready for implementation?","volume":"12","author":"Mulder","year":"2021","journal-title":"Front Genet"},{"key":"10.1016\/j.kint.2023.06.021_bib14","first-page":"248","article-title":"Improving long-term outcomes of kidney transplantation: the pressure is on","volume":"72","author":"Hesselink","year":"2014","journal-title":"Neth J Med"},{"key":"10.1016\/j.kint.2023.06.021_bib15","doi-asserted-by":"crossref","first-page":"601","DOI":"10.1111\/bcp.13838","article-title":"A\u00a0population pharmacokinetic model to predict the individual starting dose of tacrolimus in adult renal transplant recipients","volume":"85","author":"Andrews","year":"2019","journal-title":"Br J Clin Pharmacol"},{"key":"10.1016\/j.kint.2023.06.021_bib16","doi-asserted-by":"crossref","first-page":"623","DOI":"10.2165\/00003088-200443100-00001","article-title":"Clinical pharmacokinetics and pharmacodynamics of tacrolimus in solid organ transplantation","volume":"43","author":"Staatz","year":"2004","journal-title":"Clin Pharmacokinet"},{"key":"10.1016\/j.kint.2023.06.021_bib17","doi-asserted-by":"crossref","first-page":"65","DOI":"10.1007\/s00228-013-1584-7","article-title":"Importance of hematocrit for a tacrolimus target concentration strategy","volume":"70","author":"St\u00f8rset","year":"2014","journal-title":"Eur J Clin Pharmacol"},{"key":"10.1016\/j.kint.2023.06.021_bib18","doi-asserted-by":"crossref","first-page":"1357","DOI":"10.1007\/s40262-020-00922-x","article-title":"Population pharmacokinetic models of tacrolimus in adult transplant recipients: a systematic review","volume":"59","author":"Kirubakaran","year":"2020","journal-title":"Clin Pharmacokinet"},{"key":"10.1016\/j.kint.2023.06.021_bib19","doi-asserted-by":"crossref","first-page":"509","DOI":"10.1111\/bcp.12361","article-title":"Improved prediction of tacrolimus concentrations early after kidney transplantation using theory-based pharmacokinetic modelling","volume":"78","author":"St\u00f8rset","year":"2014","journal-title":"Br J Clin Pharmacol"},{"key":"10.1016\/j.kint.2023.06.021_bib20","doi-asserted-by":"crossref","first-page":"2158","DOI":"10.1097\/TP.0000000000000708","article-title":"Improved tacrolimus target concentration achievement using computerized dosing in renal transplant recipients\u2014a prospective, randomized study","volume":"99","author":"St\u00f8rset","year":"2015","journal-title":"Transplantation"},{"key":"10.1016\/j.kint.2023.06.021_bib21","doi-asserted-by":"crossref","first-page":"921","DOI":"10.1517\/17425255.2015.1033397","article-title":"Dosing algorithms for initiation of immunosuppressive drugs in solid organ transplant recipients","volume":"11","author":"Andrews","year":"2015","journal-title":"Expert Opin Drug Metab Toxicol"},{"key":"10.1016\/j.kint.2023.06.021_bib22","doi-asserted-by":"crossref","first-page":"963","DOI":"10.1007\/s40262-016-0491-3","article-title":"A\u00a0new CYP3A5\u22173 and CYP3A4\u221722 cluster influencing tacrolimus target concentrations: a population approach","volume":"56","author":"Andreu","year":"2017","journal-title":"Clin Pharmacokinet"},{"key":"10.1016\/j.kint.2023.06.021_bib23","doi-asserted-by":"crossref","first-page":"E272","DOI":"10.1111\/ctr.12101","article-title":"Individualization of tacrolimus dosage basing on cytochrome P450 3A5 polymorphism\u2014a prospective, randomized, controlled study","volume":"27","author":"Chen","year":"2013","journal-title":"Clin Transplant"},{"key":"10.1016\/j.kint.2023.06.021_bib24","doi-asserted-by":"crossref","first-page":"1198","DOI":"10.1111\/tri.12194","article-title":"Inclusion of CYP3A5 genotyping in a nonparametric population model improves dosing of tacrolimus early after transplantation","volume":"26","author":"\u00c5sberg","year":"2013","journal-title":"Transpl Int"},{"key":"10.1016\/j.kint.2023.06.021_bib25","doi-asserted-by":"crossref","first-page":"475","DOI":"10.1007\/s40262-017-0567-8","article-title":"A\u00a0population pharmacokinetic model to predict the individual starting dose of tacrolimus following pediatric renal transplantation","volume":"57","author":"Andrews","year":"2018","journal-title":"Clin Pharmacokinet"},{"key":"10.1016\/j.kint.2023.06.021_bib26","doi-asserted-by":"crossref","first-page":"425","DOI":"10.1111\/jcpt.12523","article-title":"Tacrolimus population pharmacokinetics according to CYP3A5 genotype and clinical factors in Chinese adult kidney transplant recipients","volume":"42","author":"Zhang","year":"2017","journal-title":"J\u00a0Clin Pharm Ther"},{"key":"10.1016\/j.kint.2023.06.021_bib27","doi-asserted-by":"crossref","first-page":"358","DOI":"10.3389\/fphar.2017.00358","article-title":"Tacrolimus updated guidelines through popPK modeling: how to benefit more from CYP3A pre-emptive genotyping prior to kidney transplantation","volume":"8","author":"Woillard","year":"2017","journal-title":"Front Pharmacol"},{"key":"10.1016\/j.kint.2023.06.021_bib28","doi-asserted-by":"crossref","first-page":"34","DOI":"10.1016\/j.ejps.2013.10.008","article-title":"Total plasma protein effect on tacrolimus elimination in kidney transplant patients\u2014population pharmacokinetic approach","volume":"52","author":"Golubovi\u0107","year":"2014","journal-title":"Eur J Pharm Sci"},{"key":"10.1016\/j.kint.2023.06.021_bib29","doi-asserted-by":"crossref","first-page":"2527","DOI":"10.1016\/j.drudis.2021.06.001","article-title":"Model-informed precision dosing to optimise immunosuppressive therapy in renal transplantation","volume":"26","author":"Zwart","year":"2021","journal-title":"Drug Discov Today"},{"key":"10.1016\/j.kint.2023.06.021_bib30","doi-asserted-by":"crossref","first-page":"425","DOI":"10.1111\/bcp.12076","article-title":"A\u00a0published pharmacogenetic algorithm was poorly predictive of tacrolimus clearance in an independent cohort of renal transplant recipients","volume":"76","author":"Boughton","year":"2013","journal-title":"Br J Clin Pharmacol"},{"key":"10.1016\/j.kint.2023.06.021_bib31","doi-asserted-by":"crossref","first-page":"591","DOI":"10.1007\/s40262-019-00831-8","article-title":"A\u00a0population pharmacokinetic model does not predict the optimal starting dose of tacrolimus in pediatric renal transplant recipients in a prospective study: lessons learned and model improvement","volume":"59","author":"Andrews","year":"2020","journal-title":"Clin Pharmacokinet"},{"key":"10.1016\/j.kint.2023.06.021_bib32","doi-asserted-by":"crossref","first-page":"169","DOI":"10.1002\/cpt.2163","article-title":"Avoiding tacrolimus underexposure and overexposure with a dosing algorithm for renal transplant recipients: a single arm prospective intervention trial","volume":"110","author":"Francke","year":"2021","journal-title":"Clin Pharmacol Ther"},{"key":"10.1016\/j.kint.2023.06.021_bib33","doi-asserted-by":"crossref","first-page":"246","DOI":"10.1097\/FTD.0000000000000134","article-title":"Development of a population PK model of tacrolimus for adaptive dosage control in stable kidney transplant patients","volume":"37","author":"Andreu","year":"2015","journal-title":"Ther Drug Monit"},{"key":"10.1016\/j.kint.2023.06.021_bib34","doi-asserted-by":"crossref","first-page":"56","DOI":"10.1016\/j.clinbiochem.2018.05.005","article-title":"Different top-down approaches to estimate measurement uncertainty of whole blood tacrolimus mass concentration values","volume":"57","author":"Rigo-Bonnin","year":"2018","journal-title":"Clin Biochem"},{"key":"10.1016\/j.kint.2023.06.021_bib35","doi-asserted-by":"crossref","first-page":"5397","DOI":"10.1038\/s41598-021-84868-5","article-title":"Association between medication adherence and intrapatient variability in tacrolimus concentration among stable kidney transplant recipients","volume":"11","author":"Ko","year":"2021","journal-title":"Sci Rep"},{"key":"10.1016\/j.kint.2023.06.021_bib36","doi-asserted-by":"crossref","first-page":"122","DOI":"10.1001\/jama.1994.03520020048013","article-title":"Statistical power, sample size, and their reporting in randomized controlled trials","volume":"272","author":"Moher","year":"1994","journal-title":"JAMA"},{"key":"10.1016\/j.kint.2023.06.021_bib37","doi-asserted-by":"crossref","first-page":"1139","DOI":"10.1038\/nmeth.2738","article-title":"Power and sample size","volume":"10","author":"Krywinski","year":"2013","journal-title":"Nat Methods"},{"key":"10.1016\/j.kint.2023.06.021_bib38","unstructured":"Pinheiro J, Bates D, DebRoy S, Sarkar D, R Core Team (2021). nlme: Linear and Nonlinear Mixed Effects Models. R package version 3.1-153. Accessed November 11, 2021. https:\/\/CRAN.R-project.org\/package=nlme"},{"key":"10.1016\/j.kint.2023.06.021_bib39","first-page":"189","article-title":"The pharmacogenetics of tacrolimus and its implications for personalized therapy in kidney transplant recipients","volume":"4","author":"Francke","year":"2019","journal-title":"Expert Rev Precis Med Drug Dev"},{"key":"10.1016\/j.kint.2023.06.021_bib40","doi-asserted-by":"crossref","DOI":"10.3389\/fphar.2022.912618","article-title":"Why we need to take a closer look at genetic contributions to CYP3A activity","volume":"13","author":"Zhai","year":"2022","journal-title":"Front Pharmacol"},{"key":"10.1016\/j.kint.2023.06.021_bib41","doi-asserted-by":"crossref","first-page":"640","DOI":"10.1038\/clpt.2010.42","article-title":"Dosing tacrolimus based on CYP3A5 genotype: will it improve clinical outcome?","volume":"87","author":"van Gelder","year":"2010","journal-title":"Clin Pharmacol Ther"},{"key":"10.1016\/j.kint.2023.06.021_bib42","doi-asserted-by":"crossref","DOI":"10.1111\/petr.13285","article-title":"A\u00a0randomized clinical trial of age and genotype-guided tacrolimus dosing after pediatric solid organ transplantation","volume":"22","author":"Min","year":"2018","journal-title":"Pediatr Transplant"},{"key":"10.1016\/j.kint.2023.06.021_bib43","doi-asserted-by":"crossref","first-page":"2670","DOI":"10.1111\/ajt.13788","article-title":"Long-term clinical impact of adaptation of initial tacrolimus dosing to CYP3A5 genotype","volume":"16","author":"Pallet","year":"2016","journal-title":"Am J Transplant"},{"key":"10.1016\/j.kint.2023.06.021_bib44","doi-asserted-by":"crossref","first-page":"19","DOI":"10.1002\/cpt.113","article-title":"Clinical pharmacogenetics implementation consortium (CPIC) guidelines for CYP3A5 genotype and tacrolimus dosing","volume":"98","author":"Birdwell","year":"2015","journal-title":"Clin Pharmacol Ther"},{"key":"10.1016\/j.kint.2023.06.021_bib45","doi-asserted-by":"crossref","first-page":"606","DOI":"10.1097\/FTD.0000000000000979","article-title":"Model-based tacrolimus follow-up dosing in adult renal transplant recipients: a simulation trial","volume":"44","author":"Francke","year":"2022","journal-title":"Ther Drug Monit"},{"key":"10.1016\/j.kint.2023.06.021_bib46","doi-asserted-by":"crossref","first-page":"2581","DOI":"10.1111\/bcp.14865","article-title":"A\u00a0new method to calculate intra-patient variability in tacrolimus concentrations","volume":"88","author":"van Gelder","year":"2022","journal-title":"Br J Clin Pharmacol"},{"key":"10.1016\/j.kint.2023.06.021_bib47","doi-asserted-by":"crossref","first-page":"1404","DOI":"10.1038\/ki.2013.465","article-title":"Time-dependent variability in tacrolimus trough blood levels is a risk factor for late kidney transplant failure","volume":"85","author":"Sapir-Pichhadze","year":"2014","journal-title":"Kidney Int"},{"key":"10.1016\/j.kint.2023.06.021_bib48","doi-asserted-by":"crossref","first-page":"1158","DOI":"10.1111\/tri.12798","article-title":"A\u00a0high intrapatient variability in tacrolimus exposure is associated with poor long-term outcome of kidney transplantation","volume":"29","author":"Shuker","year":"2016","journal-title":"Transpl Int"}],"container-title":["Kidney International"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0085253823004751?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S0085253823004751?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2025,9,25]],"date-time":"2025-09-25T01:05:57Z","timestamp":1758762357000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S0085253823004751"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,10]]},"references-count":48,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2023,10]]}},"alternative-id":["S0085253823004751"],"URL":"https:\/\/doi.org\/10.1016\/j.kint.2023.06.021","relation":{},"ISSN":["0085-2538"],"issn-type":[{"value":"0085-2538","type":"print"}],"subject":[],"published":{"date-parts":[[2023,10]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"A prospective controlled, randomized clinical trial of kidney transplant recipients developed personalized tacrolimus dosing using model-based Bayesian Prediction","name":"articletitle","label":"Article Title"},{"value":"Kidney International","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.kint.2023.06.021","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2023 International Society of Nephrology. Published by Elsevier Inc. All rights reserved.","name":"copyright","label":"Copyright"}]}}