{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,15]],"date-time":"2025-10-15T10:36:32Z","timestamp":1760524592294,"version":"3.40.4"},"reference-count":5,"publisher":"S. Karger AG","issue":"3","license":[{"start":{"date-parts":[[2024,1,1]],"date-time":"2024-01-01T00:00:00Z","timestamp":1704067200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2024,1,1]],"date-time":"2024-01-01T00:00:00Z","timestamp":1704067200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Am J Nephrol"],"published-print":{"date-parts":[[2024]]},"abstract":"<b><i>Introduction:<\/i><\/b> Black and African American (AA) people are over-represented in the kidney failure population; therefore, the safety and efficacy of difelikefalin in Black\/AA patients was evaluated. <b><i>Methods:<\/i><\/b> This was a post hoc, pooled exploratory subgroup analysis of the Phase 3 KALM-1 and -2 studies. Patients undergoing hemodialysis (HD) who had moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP) at enrollment were stratified into self-reported Black\/AA or White subgroups. Patients were randomized (1:1) to receive intravenous (IV) difelikefalin 0.5 \u00b5g\/kg or placebo for 12 weeks. Difelikefalin efficacy was assessed with validated patient-reported outcome questionnaires: 24-h Worst Itch Numerical Rating Scale (WI-NRS), 5-D itch, and Skindex\u201110. <b><i>Results:<\/i><\/b> There were 249 (29.3%) patients from the KALM studies that self-identified as Black\/AA (<i>n<\/i> = 135 difelikefalin; <i>n<\/i> = 114 placebo). Clinically meaningful (\u22653-point) reduction in WI-NRS score was achieved by 47.9% of Black\/AA patients with difelikefalin versus 24.6% with placebo (<i>p<\/i> &lt; 0.001). More Black\/AA patients achieved a \u22655-point 5-D itch total improvement (54.9% vs. 35.7%; <i>p<\/i> = 0.013) and a \u226515-point Skindex-10 score improvement with difelikefalin versus placebo (49.0% vs. 28.9%; <i>p<\/i> = 0.006) compared with White patients. Incidence of treatment-emergent adverse events (TEAEs) was higher for Black\/AA patients (difelikefalin: 78.5%; placebo: 70.8%) versus White patients (difelikefalin: 64.8%; placebo: 61.8%). <b><i>Conclusion:<\/i><\/b> In this post hoc analysis, difelikefalin was efficacious in the Black\/AA population and had an acceptable safety profile. <\/jats:p>","DOI":"10.1159\/000534227","type":"journal-article","created":{"date-parts":[[2024,2,26]],"date-time":"2024-02-26T22:00:31Z","timestamp":1708984831000},"page":"329-333","source":"Crossref","is-referenced-by-count":1,"title":["Difelikefalin in Black\/African American Hemodialysis Patients with Moderate-to-Severe Pruritus: Post hoc Analysis of KALM-1 and KALM-2"],"prefix":"10.1159","volume":"55","author":[{"given":"Steven","family":"Fishbane","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Deborah J.","family":"Clegg","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Edgar V.","family":"Lerma","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anjay","family":"Rastogi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jeffrey","family":"Budden","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Isabelle","family":"Morin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Warren","family":"Wen","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Fr\u00e9d\u00e9rique","family":"Menzaghi","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Joel","family":"Topf","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"127","published-online":{"date-parts":[[2024,1,22]]},"reference":[{"doi-asserted-by":"publisher","key":"ref1","DOI":"10.1016\/j.xkme.2022.100513"},{"doi-asserted-by":"publisher","key":"ref2","DOI":"10.1016\/j.xkme.2022.100512"},{"doi-asserted-by":"publisher","key":"ref3","DOI":"10.1056\/NEJMoa1912770"},{"doi-asserted-by":"publisher","key":"ref4","DOI":"10.1016\/j.jaad.2020.06.991"},{"doi-asserted-by":"publisher","key":"ref5","DOI":"10.1136\/medethics-2018-104811"}],"container-title":["American Journal of Nephrology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/karger.com\/ajn\/article-pdf\/55\/3\/329\/4235667\/000534227.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/karger.com\/ajn\/article-pdf\/55\/3\/329\/4235667\/000534227.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,4,23]],"date-time":"2025-04-23T15:44:51Z","timestamp":1745423091000},"score":1,"resource":{"primary":{"URL":"https:\/\/karger.com\/article\/doi\/10.1159\/000534227"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024]]},"references-count":5,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2024,6,3]]},"published-print":{"date-parts":[[2024,6,5]]}},"URL":"https:\/\/doi.org\/10.1159\/000534227","archive":["Portico"],"relation":{"is-supplemented-by":[{"id-type":"doi","id":"10.6084\/m9.figshare.25037651","asserted-by":"subject"}]},"ISSN":["0250-8095","1421-9670"],"issn-type":[{"type":"print","value":"0250-8095"},{"type":"electronic","value":"1421-9670"}],"subject":[],"published":{"date-parts":[[2024]]}}}