{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,28]],"date-time":"2026-08-28T16:22:16Z","timestamp":1787934136846,"version":"build-2784847793"},"reference-count":18,"publisher":"S. Karger AG","issue":"2","license":[{"start":{"date-parts":[[2012,1,1]],"date-time":"2012-01-01T00:00:00Z","timestamp":1325376000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/3.0\/"},{"start":{"date-parts":[[2012,1,1]],"date-time":"2012-01-01T00:00:00Z","timestamp":1325376000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/3.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Am J Nephrol"],"published-print":{"date-parts":[[2012]]},"abstract":"<jats:p>&lt;b&gt;&lt;i&gt;Background:&lt;\/i&gt;&lt;\/b&gt; Our previous placebo-controlled, prospective, double-blind study demonstrated that a new opioid \u0138-receptor agonist, nalfurafine hydrochloride, effectively reduced treatment-resistant pruritus in 337 hemodialysis patients. Thus, we designed this study to evaluate prospectively the efficacy, safety, addiction liability, and pharmacokinetics of nalfurafine given orally for 1 year. &lt;b&gt;&lt;i&gt;Methods:&lt;\/i&gt;&lt;\/b&gt; This open-label study examined the effects and adverse drug reactions (ADRs) of 52-week oral administration of nalfurafine hydrochloride (5 \u00b5g\/day) in 211 hemodialysis patients with a treatment-resistant itch. &lt;b&gt;&lt;i&gt;Results:&lt;\/i&gt;&lt;\/b&gt; Of 211 patients, 145 completed the study as scheduled. The mean pruritus value assessed by the visual analogue scale was 75.2 mm during the pre-observation period, which decreased significantly to 50.9 and 30.9 mm in week 2 and 52, respectively, indicating a long-lasting efficacy. ADRs occurred in 103 patients (48.8%). Frequent ADRs were insomnia (sleep disturbance, 19.4%), constipation (7.1%) and increased blood prolactin (3.3%), similar to previous reports. Regarding addiction liability, it appeared unlikely that nalfurafine hydrochloride was abused. After the start of treatment, plasma drug levels reached a steady state in week 2 with no apparent tendency of systemic accumulation. &lt;b&gt;&lt;i&gt;Conclusions:&lt;\/i&gt;&lt;\/b&gt; Nalfurafine hydrochloride, orally administered at 5 \u00b5g\/day for 52 weeks to hemodialysis patients, produced a long-term suppression of pruritus without significant safety problems.<\/jats:p>","DOI":"10.1159\/000341268","type":"journal-article","created":{"date-parts":[[2012,8,3]],"date-time":"2012-08-03T04:52:50Z","timestamp":1343969570000},"page":"175-183","source":"Crossref","is-referenced-by-count":137,"title":["Efficacy and Safety of a Novel \u0138-Agonist for Managing Intractable Pruritus in Dialysis Patients"],"prefix":"10.1159","volume":"36","author":[{"given":"Hiroo","family":"Kumagai","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshiya","family":"Ebata","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenji","family":"Takamori","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Katsumasa","family":"Miyasato","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Taro","family":"Muramatsu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hidetomo","family":"Nakamoto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masanao","family":"Kurihara","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomoji","family":"Yanagita","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiromichi","family":"Suzuki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"127","published-online":{"date-parts":[[2012,8,3]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","DOI":"10.1038%2Fnrn1950"},{"key":"ref2","doi-asserted-by":"publisher","DOI":"10.1093%2Fndt%2F14.4.834"},{"key":"ref3","doi-asserted-by":"publisher","DOI":"10.1093%2Fndt%2F17.9.1558"},{"key":"ref4","doi-asserted-by":"publisher","DOI":"10.1016%2FS0140-6736%2803%2912570-6"},{"key":"ref5","doi-asserted-by":"publisher","DOI":"10.1053%2Fj.ajkd.2007.03.010"},{"key":"ref6","doi-asserted-by":"publisher","DOI":"10.1093%2Fndt%2Fgfl461"},{"key":"ref7","doi-asserted-by":"publisher","DOI":"10.1038%2Fsj.ki.5000251"},{"key":"ref8","doi-asserted-by":"publisher","DOI":"10.1016%2Fj.jaad.2005.12.010"},{"key":"ref9","doi-asserted-by":"publisher","DOI":"10.1016%2FS0014-2999%2899%2900369-6"},{"key":"ref10","doi-asserted-by":"publisher","DOI":"10.1248%2Fcpb.46.366"},{"key":"ref11","doi-asserted-by":"publisher","DOI":"10.1016%2Fj.lfs.2004.05.033"},{"key":"ref12","doi-asserted-by":"publisher","DOI":"10.1016%2FS0014-2999%2801%2901588-6"},{"key":"ref13","doi-asserted-by":"publisher","DOI":"10.1016%2Fj.ejphar.2003.08.007"},{"key":"ref14","doi-asserted-by":"publisher","DOI":"10.1016%2FS0014-2999%2801%2900941-4"},{"key":"ref15","doi-asserted-by":"publisher","DOI":"10.1681%2FASN.2005020152"},{"key":"ref16","doi-asserted-by":"publisher","DOI":"10.1093%2Fndt%2Fgfp588"},{"key":"ref17","doi-asserted-by":"publisher","DOI":"10.1046%2Fj.1365-2133.2003.05293.x"},{"key":"ref18","doi-asserted-by":"publisher","DOI":"10.1007%2Fs11920-005-0049-9"}],"container-title":["American Journal of Nephrology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.karger.com\/Article\/Pdf\/341268","content-type":"unspecified","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.karger.com\/Article\/Pdf\/341268","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/www.karger.com\/Article\/Pdf\/341268","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,4,23]],"date-time":"2025-04-23T14:36:46Z","timestamp":1745419006000},"score":1,"resource":{"primary":{"URL":"https:\/\/karger.com\/article\/doi\/10.1159\/000341268"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2012]]},"references-count":18,"journal-issue":{"issue":"2","published-online":{"date-parts":[[2012,8,1]]},"published-print":{"date-parts":[[2012,8,24]]}},"URL":"https:\/\/doi.org\/10.1159\/000341268","archive":["Portico"],"relation":{},"ISSN":["0250-8095","1421-9670"],"issn-type":[{"value":"0250-8095","type":"print"},{"value":"1421-9670","type":"electronic"}],"subject":[],"published":{"date-parts":[[2012]]}}}