{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,3]],"date-time":"2026-06-03T00:58:00Z","timestamp":1780448280267,"version":"3.54.1"},"reference-count":37,"publisher":"S. Karger AG","issue":"10","license":[{"start":{"date-parts":[[2024,4,24]],"date-time":"2024-04-24T00:00:00Z","timestamp":1713916800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2024,4,24]],"date-time":"2024-04-24T00:00:00Z","timestamp":1713916800000},"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":["Nephron"],"abstract":"<jats:p>Background: Early secondary hyperparathyroidism (SHPT) diagnosis and treatment are crucial to delay the progression of SHPT and related complications, in particular, cardiovascular events and bone fractures. Extended-release calcifediol (ERC) has been developed for the treatment of SHPT in patients with stage 3\/4 chronic kidney disease (CKD) and vitamin D insufficiency (VDI). Summary: This review compares baseline characteristics and treatment responses of SHPT patients receiving ERC in phase 3 studies with those treated with ERC in a real-world study. Mean \u00b1 standard deviation baseline parathyroid hormone (PTH) levels were 147 \u00b1 56 pg\/mL and 148 \u00b1 64 pg\/mL in the phase 3 ERC cohorts, and 181 \u00b1 98 pg\/mL in the real-world study. Other baseline laboratory parameters were consistent between the clinical and real-world studies. ERC treatment increased 25-hydroxyvitamin D (25(OH)D) and significantly reduced PTH levels, regardless of baseline CKD stage, in all studies. In the pooled phase 3 per-protocol populations, 74% of the ERC cohort were uptitrated to 60 \u03bcg\/day after 12 weeks at 30 \u03bcg\/day, 97% attained 25(OH)D levels \u226530 ng\/mL, and 40% achieved \u226530% PTH reduction. Despite a much lower rate of uptitration in the real-world study, 70% of patients achieved 25(OH)D levels \u226530 ng\/mL, and 40% had a \u226530% reduction in PTH. Key Messages: These data establish a \u201ccontinuum\u201d of clinical and real-world evidence of ERC effectiveness for treating SHPT, irrespective of CKD stage, baseline PTH levels, and ERC dose. This evidence supports early treatment initiation with ERC, following diagnosis of SHPT, VDI, and stage 3 CKD, to delay SHPT progression. <\/jats:p>","DOI":"10.1159\/000538818","type":"journal-article","created":{"date-parts":[[2024,4,24]],"date-time":"2024-04-24T21:00:41Z","timestamp":1713992441000},"page":"657-666","source":"Crossref","is-referenced-by-count":3,"title":["Extended-Release Calcifediol: A Data Journey from Phase 3 Studies to Real-World Evidence Highlights the Importance of Early Treatment of Secondary Hyperparathyroidism"],"prefix":"10.1159","volume":"148","author":[{"given":"Domenico","family":"Merante","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Henrik","family":"Schou","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isabelle","family":"Morin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marius","family":"Manu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akhtar","family":"Ashfaq","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charles","family":"Bishop","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen","family":"Strugnell","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"127","published-online":{"date-parts":[[2024,4,24]]},"reference":[{"key":"ref1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(20)30045-3"},{"key":"ref2","doi-asserted-by":"publisher","DOI":"10.1185\/03007990802437943"},{"key":"ref3","doi-asserted-by":"publisher","DOI":"10.1038\/sj.ki.5002009"},{"key":"ref4","doi-asserted-by":"publisher","DOI":"10.1007\/s40620-021-01082-2"},{"key":"ref5","doi-asserted-by":"publisher","DOI":"10.2215\/CJN.13411119"},{"key":"ref6","doi-asserted-by":"publisher","DOI":"10.3390\/ijms232012223"},{"key":"ref7","doi-asserted-by":"publisher","DOI":"10.1093\/ckj\/sfy061"},{"key":"ref8","doi-asserted-by":"publisher","DOI":"10.1080\/14656566.2019.1663826"},{"key":"ref9","doi-asserted-by":"publisher","DOI":"10.2215\/CJN.06040710"},{"key":"ref10","doi-asserted-by":"publisher","DOI":"10.1007\/s00198-019-05033-3"},{"key":"ref11","doi-asserted-by":"publisher","DOI":"10.1016\/j.ekir.2020.11.023"},{"key":"ref12","doi-asserted-by":"publisher","DOI":"10.1038\/nrneph.2009.185"},{"key":"ref13","doi-asserted-by":"publisher","DOI":"10.1038\/ki.2008.501"},{"key":"ref14","doi-asserted-by":"publisher","DOI":"10.1038\/ki.2009.188"},{"key":"ref15","doi-asserted-by":"publisher","DOI":"10.1007\/s40620-015-0186-0"},{"key":"ref16","doi-asserted-by":"publisher","DOI":"10.1053\/j.ajkd.2022.06.006"},{"key":"ref17","doi-asserted-by":"publisher","DOI":"10.1159\/000499187"},{"key":"ref18","doi-asserted-by":"publisher","DOI":"10.1016\/j.semnephrol.2014.02.007"},{"key":"ref19","doi-asserted-by":"publisher","DOI":"10.1016\/j.kint.2017.04.006"},{"key":"ref20","doi-asserted-by":"publisher","DOI":"10.1007\/s00198-018-4520-y"},{"key":"ref21","doi-asserted-by":"publisher","DOI":"10.1097\/MNH.0b013e3283477a7b"},{"key":"ref22","doi-asserted-by":"publisher","DOI":"10.2215\/CJN.00530117"},{"key":"ref23","doi-asserted-by":"publisher","DOI":"10.1016\/j.jsbmb.2014.11.022"},{"key":"ref24","doi-asserted-by":"publisher","DOI":"10.1093\/ckj\/sfab091"},{"key":"ref25","doi-asserted-by":"publisher","DOI":"10.1002\/prp2.605"},{"key":"ref26","doi-asserted-by":"publisher","DOI":"10.1359\/jbmr.070305"},{"key":"ref27","doi-asserted-by":"publisher","DOI":"10.1210\/clinem\/dgad289"},{"key":"ref28","doi-asserted-by":"publisher","DOI":"10.1681\/ASN.2013010103"},{"key":"ref29","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2012.120"},{"key":"ref30","doi-asserted-by":"publisher","DOI":"10.1159\/000450766"},{"key":"ref31","doi-asserted-by":"publisher","DOI":"10.1159\/000518545"},{"key":"ref32","doi-asserted-by":"publisher","DOI":"10.1186\/s12882-022-02993-3"},{"key":"ref33","doi-asserted-by":"publisher","DOI":"10.1530\/ERC-19-0284"},{"key":"ref34","doi-asserted-by":"publisher","DOI":"10.1159\/000524289"},{"key":"ref35","doi-asserted-by":"publisher","DOI":"10.1080\/17446651.2017.1347501"},{"key":"ref36","doi-asserted-by":"publisher","DOI":"10.1038\/bonekey.2013.232"},{"key":"ref37","doi-asserted-by":"publisher","DOI":"10.1681\/ASN.2005111194"}],"container-title":["Nephron"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/karger.com\/nef\/article-pdf\/148\/10\/657\/4287231\/000538818.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/karger.com\/nef\/article-pdf\/148\/10\/657\/4287231\/000538818.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,4,23]],"date-time":"2025-04-23T15:16:10Z","timestamp":1745421370000},"score":1,"resource":{"primary":{"URL":"https:\/\/karger.com\/article\/doi\/10.1159\/000538818"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2024,4,24]]},"references-count":37,"journal-issue":{"issue":"10","published-online":{"date-parts":[[2024,10,8]]},"published-print":{"date-parts":[[2024,9,9]]}},"URL":"https:\/\/doi.org\/10.1159\/000538818","archive":["Portico"],"relation":{},"ISSN":["1660-8151","2235-3186"],"issn-type":[{"value":"1660-8151","type":"print"},{"value":"2235-3186","typ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