{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,4]],"date-time":"2026-11-04T00:55:34Z","timestamp":1793753734782,"version":"4.6.1"},"reference-count":24,"publisher":"Elsevier BV","issue":"8","license":[{"start":{"date-parts":[[2022,8,1]],"date-time":"2022-08-01T00:00:00Z","timestamp":1659312000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/tdm\/userlicense\/1.0\/"},{"start":{"date-parts":[[2022,8,1]],"date-time":"2022-08-01T00:00:00Z","timestamp":1659312000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.elsevier.com\/legal\/tdmrep-license"},{"start":{"date-parts":[[2022,6,22]],"date-time":"2022-06-22T00:00:00Z","timestamp":1655856000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100014425","name":"Acorda Therapeutics","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100014425","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004325","name":"AstraZeneca","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004325","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["kidneymedicinejournal.org","elsevier.com","sciencedirect.com"],"crossmark-restriction":true},"short-container-title":["Kidney Medicine"],"published-print":{"date-parts":[[2022,8]]},"DOI":"10.1016\/j.xkme.2022.100513","type":"journal-article","created":{"date-parts":[[2022,6,28]],"date-time":"2022-06-28T21:42:48Z","timestamp":1656452568000},"page":"100513","update-policy":"https:\/\/doi.org\/10.1016\/elsevier_cm_policy","source":"Crossref","is-referenced-by-count":48,"title":["Safety and Tolerability of Difelikefalin for the Treatment of Moderate to Severe Pruritus in Hemodialysis Patients: Pooled Analysis From the Phase 3 Clinical Trial Program"],"prefix":"10.1016","volume":"4","author":[{"given":"Steven","family":"Fishbane","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Warren","family":"Wen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catherine","family":"Munera","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rong","family":"Lin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sukirti","family":"Bagal","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kieran","family":"McCafferty","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fr\u00e9d\u00e9rique","family":"Menzaghi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joana","family":"Goncalves","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"78","reference":[{"issue":"7","key":"10.1016\/j.xkme.2022.100513_bib1","first-page":"e5178","article-title":"Uremic pruritus: prevalence and impact on quality of life and depressive symptoms in hemodialysis patients","volume":"11","author":"Satti","year":"2019","journal-title":"Cureus"},{"issue":"1","key":"10.1016\/j.xkme.2022.100513_bib2","doi-asserted-by":"crossref","first-page":"102","DOI":"10.1186\/s12882-019-1294-1","article-title":"Sleep disturbance among Malaysian patients with end-stage renal disease with pruritus","volume":"20","author":"Rehman","year":"2019","journal-title":"BMC Nephrol"},{"key":"10.1016\/j.xkme.2022.100513_bib3","doi-asserted-by":"crossref","first-page":"11","DOI":"10.2147\/IJNRD.S108045","article-title":"Chronic kidney disease-associated pruritus: impact on quality of life and current management challenges","volume":"10","author":"Shirazian","year":"2017","journal-title":"Int J Nephrol Renovasc Dis"},{"issue":"1","key":"10.1016\/j.xkme.2022.100513_bib4","doi-asserted-by":"crossref","first-page":"11","DOI":"10.1053\/j.ajkd.2007.03.010","article-title":"An update on pruritus associated with CKD","volume":"50","author":"Patel","year":"2007","journal-title":"Am J Kidney Dis"},{"issue":"9","key":"10.1016\/j.xkme.2022.100513_bib5","doi-asserted-by":"crossref","first-page":"1387","DOI":"10.1016\/j.ekir.2020.04.027","article-title":"CKD-associated pruritus: new insights into diagnosis, pathogenesis, and management","volume":"5","author":"Verduzco","year":"2020","journal-title":"Kidney Int Rep"},{"issue":"1","key":"10.1016\/j.xkme.2022.100513_bib6","doi-asserted-by":"crossref","first-page":"42","DOI":"10.1016\/j.xkme.2020.08.011","article-title":"Self-reported pruritus and clinical, dialysis-related, and patient-reported outcomes in hemodialysis patients","volume":"3","author":"Sukul","year":"2021","journal-title":"Kidney Med"},{"issue":"12","key":"10.1016\/j.xkme.2022.100513_bib7","doi-asserted-by":"crossref","first-page":"3495","DOI":"10.1093\/ndt\/gfl461","article-title":"Pruritus in haemodialysis patients: international results from the Dialysis Outcomes and Practice Patterns Study (DOPPS)","volume":"21","author":"Pisoni","year":"2006","journal-title":"Nephrol Dial Transplant"},{"issue":"4","key":"10.1016\/j.xkme.2022.100513_bib8","doi-asserted-by":"crossref","first-page":"412","DOI":"10.1111\/ijd.14708","article-title":"Gabapentin for uremic pruritus: a systematic review of randomized controlled trials","volume":"59","author":"Eusebio-Alpapara","year":"2020","journal-title":"Int J Dermatol"},{"issue":"12","key":"10.1016\/j.xkme.2022.100513_bib9","first-page":"CD011393","article-title":"Interventions for itch in people with advanced chronic kidney disease","volume":"12","author":"Hercz","year":"2020","journal-title":"Cochrane Database Syst Rev"},{"issue":"5","key":"10.1016\/j.xkme.2022.100513_bib10","doi-asserted-by":"crossref","first-page":"555","DOI":"10.2340\/00015555-1353","article-title":"Systemic kappa opioid receptor agonists in the treatment of chronic pruritus: a literature review","volume":"92","author":"Phan","year":"2012","journal-title":"Acta Derm Venereol"},{"key":"10.1016\/j.xkme.2022.100513_bib11","unstructured":"Korsuva (Difelikefalin) [Package Insert]. Cara Therapeutics, Inc.; 2021. Accessed April 14, 2022. https:\/\/www.korsuva.com\/pi"},{"key":"10.1016\/j.xkme.2022.100513_bib13","doi-asserted-by":"crossref","first-page":"1267","DOI":"10.2147\/TCRM.S310550","article-title":"Chronic intractable pruritus in chronic kidney disease patients: prevalence, impact, and management challenges \u2013a narrative review","volume":"17","author":"\u015awierczy\u0144ska","year":"2021","journal-title":"Ther Clin Risk Manag"},{"issue":"12","key":"10.1016\/j.xkme.2022.100513_bib14","doi-asserted-by":"crossref","first-page":"2000","DOI":"10.2215\/CJN.03280317","article-title":"International comparisons of prevalence, awareness, and treatment of pruritus in people on hemodialysis","volume":"12","author":"Rayner","year":"2017","journal-title":"Clin J Am Soc Nephrol"},{"key":"10.1016\/j.xkme.2022.100513_bib15","doi-asserted-by":"crossref","first-page":"9","DOI":"10.2147\/IJNRD.S145720","article-title":"Post-marketing surveillance study of the safety and efficacy of nalfurafine hydrochloride (Remitch\u00ae capsules 2.5 \u03bcg) in 3,762 hemodialysis patients with intractable pruritus","volume":"11","author":"Kozono","year":"2018","journal-title":"Int J Nephrol Renovasc Dis"},{"key":"10.1016\/j.xkme.2022.100513_bib16","first-page":"338A","article-title":"Antipruritic effect of the long-acting peripheral kappa opioid receptor agonist CR845: a novel approach for the treatment of uremic pruritus in hemodialysis patients [abstract]","volume":"27","author":"Spencer","year":"2016","journal-title":"J\u00a0Am Soc Nephrol"},{"issue":"suppl","key":"10.1016\/j.xkme.2022.100513_bib17","doi-asserted-by":"crossref","first-page":"22","DOI":"10.1681\/ASN.20203110S122d","article-title":"Efficacy and safety of difelikefalin for moderate-to-severe CKD\u2013associated pruritus: a global phase 3 study in hemodialysis patients (KALM-2) [abstract FR-OR24]","volume":"31","author":"Wooldridge","year":"2020","journal-title":"J\u00a0Am Soc Nephrol"},{"issue":"4","key":"10.1016\/j.xkme.2022.100513_bib18","doi-asserted-by":"crossref","first-page":"371","DOI":"10.1111\/jcpt.12404","article-title":"Will peripherally restricted kappa-opioid receptor agonists (pKORAs) relieve pain with less opioid adverse effects and abuse potential?","volume":"41","author":"Albert-Vartanian","year":"2016","journal-title":"J\u00a0Clin Pharm Ther"},{"issue":"3","key":"10.1016\/j.xkme.2022.100513_bib19","doi-asserted-by":"crossref","first-page":"222","DOI":"10.1056\/NEJMoa1912770","article-title":"KALM-1 Trial Investigators. A phase 3 trial of difelikefalin in hemodialysis patients with pruritus","volume":"382","author":"Fishbane","year":"2020","journal-title":"N\u00a0Engl J Med"},{"issue":"8","key":"10.1016\/j.xkme.2022.100513_bib20","doi-asserted-by":"crossref","first-page":"100512","DOI":"10.1016\/j.xkme.2022.100512","article-title":"Efficacy of difelikefalin for the treatment of moderate to severe pruritus in hemodialysis patients: pooled analysis of KALM-1 and KALM-2 phase 3 studies","volume":"4","author":"Topf","year":"2022","journal-title":"Kidney Med"},{"issue":"5","key":"10.1016\/j.xkme.2022.100513_bib21","doi-asserted-by":"crossref","first-page":"600","DOI":"10.1016\/j.ekir.2020.01.006","article-title":"Randomized controlled trial of difelikefalin for chronic pruritus in hemodialysis patients","volume":"5","author":"Fishbane","year":"2020","journal-title":"Kidney Int Rep"},{"issue":"4","key":"10.1016\/j.xkme.2022.100513_bib22","doi-asserted-by":"crossref","first-page":"383","DOI":"10.1016\/j.semnephrol.2015.06.009","article-title":"Pruritus in kidney disease","volume":"35","author":"Combs","year":"2015","journal-title":"Semin Nephrol"},{"key":"10.1016\/j.xkme.2022.100513_bib23","series-title":"USRDS Annual Data Report: Epidemiology of Kidney Disease in the United States","year":"2020"},{"issue":"10225","key":"10.1016\/j.xkme.2022.100513_bib24","doi-asserted-by":"crossref","first-page":"709","DOI":"10.1016\/S0140-6736(20)30045-3","article-title":"Global, regional, and national burden of chronic kidney disease, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017","volume":"395","year":"2020","journal-title":"Lancet"},{"issue":"5","key":"10.1016\/j.xkme.2022.100513_bib25","doi-asserted-by":"crossref","first-page":"673","DOI":"10.2215\/CJN.09600818","article-title":"Pruritus and patient reported outcomes in non-dialysis CKD","volume":"14","author":"Sukul","year":"2019","journal-title":"Clin J Am Soc Nephrol"}],"container-title":["Kidney Medicine"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S2590059522001340?httpAccept=text\/xml","content-type":"text\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/api.elsevier.com\/content\/article\/PII:S2590059522001340?httpAccept=text\/plain","content-type":"text\/plain","content-version":"vor","intended-application":"text-mining"}],"deposited":{"date-parts":[[2025,11,12]],"date-time":"2025-11-12T01:23:06Z","timestamp":1762910586000},"score":1,"resource":{"primary":{"URL":"https:\/\/linkinghub.elsevier.com\/retrieve\/pii\/S2590059522001340"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2022,8]]},"references-count":24,"journal-issue":{"issue":"8","published-print":{"date-parts":[[2022,8]]}},"alternative-id":["S2590059522001340"],"URL":"https:\/\/doi.org\/10.1016\/j.xkme.2022.100513","relation":{},"ISSN":["2590-0595"],"issn-type":[{"value":"2590-0595","type":"print"}],"subject":[],"published":{"date-parts":[[2022,8]]},"assertion":[{"value":"Elsevier","name":"publisher","label":"This article is maintained by"},{"value":"Safety and Tolerability of Difelikefalin for the Treatment of Moderate to Severe Pruritus in Hemodialysis Patients: Pooled Analysis From the Phase 3 Clinical Trial Program","name":"articletitle","label":"Article Title"},{"value":"Kidney Medicine","name":"journaltitle","label":"Journal Title"},{"value":"https:\/\/doi.org\/10.1016\/j.xkme.2022.100513","name":"articlelink","label":"CrossRef DOI link to publisher maintained version"},{"value":"article","name":"content_type","label":"Content Type"},{"value":"\u00a9 2022 The Authors. Published by Elsevier Inc. on behalf of the National Kidney Foundation, Inc.","name":"copyright","label":"Copyright"}],"article-number":"100513"}}