{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,18]],"date-time":"2026-03-18T01:45:18Z","timestamp":1773798318482,"version":"3.50.1"},"reference-count":31,"publisher":"Oxford University Press (OUP)","issue":"10","license":[{"start":{"date-parts":[[2024,3,7]],"date-time":"2024-03-07T00:00:00Z","timestamp":1709769600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"name":"Shanghai Alebund Pharmaceuticals Limited"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2024,9,27]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>VS-505 (AP301), an acacia and ferric oxyhydroxide polymer, is a novel fiber-iron-based phosphate binder. This two-part Phase 2 study evaluated the tolerability, safety and efficacy of oral VS-505 administered three times daily with meals in treating hyperphosphatemia in chronic kidney disease (CKD) patients receiving maintenance hemodialysis (MHD).<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>In Part 1, patients received dose-escalated treatment with VS-505 2.25, 4.50 and 9.00\u00a0g\/day for 2\u00a0weeks each, guided by serum phosphorus levels. In Part 2, patients received randomized, open-label, fixed-dosage treatment with VS-505 (1.50, 2.25, 4.50 or 6.75\u00a0g\/day) or sevelamer carbonate 4.80\u00a0g\/day for 6\u00a0weeks. The primary efficacy endpoint was the change in serum phosphorus.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>The study enrolled 158 patients (Part 1: 25; Part 2: 133), with 130 exposed to VS-505 in total. VS-505 was well tolerated. The most common adverse events were gastrointestinal disorders, mainly feces discolored (56%) and diarrhea (15%; generally during Weeks 1\u20132 of treatment). Most gastrointestinal disorders resolved without intervention, and none was serious. In Part 1, serum phosphorus significantly improved (mean change \u22122.0\u00a0mg\/dL; 95% confidence interval \u22122.7, \u22121.4) after VS-505 dose escalation. In Part 2, serum phosphorus significantly and dose-dependently improved in all VS-505 arms, with clinically meaningful reductions with VS-505 4.50 and 6.75\u00a0g\/day, and sevelamer carbonate 4.80\u00a0g\/day [mean change \u22121.6 (\u22122.2, \u22121.0), \u22121.8 (\u22122.4, \u22121.2) and \u22121.4 (\u22122.2, \u22120.5) mg\/dL, respectively]. In both parts, serum phosphorus reductions occurred within 1\u00a0week of VS-505 initiation, returning to baseline within 2\u00a0weeks of VS-505 discontinuation.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusion<\/jats:title>\n                  <jats:p>VS-505, a novel phosphate binder, was well tolerated with a manageable safety profile, and effectively and dose-dependently reduced serum phosphorus in CKD patients with hyperphosphatemia receiving MHD.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Clinical Trial registration number<\/jats:title>\n                  <jats:p>NCT04551300\u2009<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/ndt\/gfae053","type":"journal-article","created":{"date-parts":[[2024,3,8]],"date-time":"2024-03-08T02:17:41Z","timestamp":1709864261000},"page":"1649-1661","source":"Crossref","is-referenced-by-count":2,"title":["Tolerability, safety and efficacy of a novel phosphate binder VS-505 (AP301): a Phase 2 dose-escalation and dose-ranging study in patients undergoing maintenance hemodialysis"],"prefix":"10.1093","volume":"39","author":[{"given":"Bing","family":"Zhuang","sequence":"first","affiliation":[{"name":"Center for Kidney Disease, Second Affiliated Hospital, Nanjing Medical University , Nanjing ,","place":["China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Liangying","family":"Gan","sequence":"additional","affiliation":[{"name":"Department of Nephrology, Peking University People's Hospital , Beijing ,","place":["China"]}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bin","family":"Liu","sequence":"additional","affiliation":[{"name":"Nephrology Department, Wuxi People\u2019s Hospital Affiliated to Nanjing Medical University , Wuxi 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