{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,10]],"date-time":"2026-08-10T14:40:53Z","timestamp":1786372853189,"version":"build-2736575974"},"reference-count":22,"publisher":"Ovid Technologies (Wolters Kluwer Health)","issue":"1","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["CJASN"],"published-print":{"date-parts":[[2019,1]]},"abstract":"\n Background and objectives<\/jats:title>\n \n Patiromer is a sodium-free, nonabsorbed, potassium-binding polymer that uses calcium as the counter-exchange ion and is approved for treatment of hyperkalemia. The 4-week TOURMALINE study in patients with hyperkalemia previously demonstrated that patiromer administered once daily reduces serum potassium similarly when given with or without food. We report a prespecified exploratory efficacy analysis as well as a\n post hoc<\/jats:italic>\n efficacy and safety analysis of the TOURMALINE study on circulating markers of mineral metabolism.\n <\/jats:p>\n <\/jats:sec>\n \n Design, setting, participants, & measurements<\/jats:title>\n \n Adults with hyperkalemia (potassium >5.0 mEq\/L) were randomized to once-daily patiromer 8.4 g without\/with food for 4 weeks, with doses adjusted to achieve and maintain serum potassium 3.8\u20135.0 mEq\/L. Baseline and week 4 serum and 24-hour urine markers of mineral metabolism are reported for all patients combined (evaluable for efficacy,\n n<\/jats:italic>\n =112; evaluable for safety,\n n<\/jats:italic>\n =113).\n P<\/jats:italic>\n values were calculated using a paired\n t<\/jats:italic>\n test for change from baseline, unless otherwise specified.\n <\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n \n Mean (SD) baseline eGFR was 41\u00b126 ml\/min per 1.73 m\n 2<\/jats:sup>\n . Mean (SD) changes from baseline to week 4 were 0.0\u00b10.5 mg\/dl (\n P<\/jats:italic>\n =0.78;\n n<\/jats:italic>\n =100) for albumin-corrected serum calcium, \u22120.2\u00b10.2 mg\/dl (\n P<\/jats:italic>\n <0.001;\n n<\/jats:italic>\n =100) for serum magnesium, and \u22120.1\u00b10.7 mg\/dl (\n P<\/jats:italic>\n =0.47;\n n<\/jats:italic>\n =100) for serum phosphate. Median (quartile 1, quartile 3) changes in 24-hour creatinine-normalized urine calcium and phosphate from baseline to week 4 were 2.5 (\u221211.5, 23.7) mg\/24 h (\n P<\/jats:italic>\n =0.10;\n n<\/jats:italic>\n =69) and \u221243.0 (\u2212162.6, 35.7) mg\/24 h (\n P<\/jats:italic>\n =0.004;\n n<\/jats:italic>\n =95), respectively. Median (quartile 1, quartile 3) changes in intact parathyroid hormone and 1,25-dihydroxyvitamin D from baseline to week 4 were \u221213 (\u221231, 4) pg\/ml (\n P<\/jats:italic>\n <0.001;\n n<\/jats:italic>\n =97) and \u22122 (\u22129, 3) pg\/ml (\n P<\/jats:italic>\n =0.05;\n n<\/jats:italic>\n =96), respectively. There were no changes in fibroblast growth factor-23 or 25-hydroxyvitamin D. In patients (\n n<\/jats:italic>\n =16) with baseline serum phosphate >4.8 mg\/dL, the mean (SD) changes in serum and 24-hour creatinine-normalized urine phosphate from baseline to Week 4 were \u22120.6\u00b10.8 mg\/dl (\n n<\/jats:italic>\n =13) and \u2212149.1\u00b1162.6 mg\/24hr (\n n<\/jats:italic>\n =9), respectively.\n <\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n Patiromer lowered urine phosphate in all patients, and lowered both serum and urine phosphate in a small subset of patients with hyperphosphatemia. Intact parathyroid hormone and 1,25-dihydroxyvitamin D decreased, with no change in serum calcium.<\/jats:p>\n <\/jats:sec>","DOI":"10.2215\/cjn.04500418","type":"journal-article","created":{"date-parts":[[2018,10,31]],"date-time":"2018-10-31T14:05:39Z","timestamp":1540994739000},"page":"103-110","source":"Crossref","is-referenced-by-count":13,"title":["Effects of the Potassium-Binding Polymer Patiromer on Markers of Mineral Metabolism"],"prefix":"10.2215","volume":"14","clinical-trial-number":[{"clinical-trial-number":"nct02694744","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"David A.","family":"Bushinsky","sequence":"first","affiliation":[{"name":"Division of Nephrology, Department of Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David M.","family":"Spiegel","sequence":"additional","affiliation":[{"name":"Clinical Development;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jinwei","family":"Yuan","sequence":"additional","affiliation":[{"name":"Biometrics;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Suzette","family":"Warren","sequence":"additional","affiliation":[{"name":"Clinical Operations;"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeanene","family":"Fogli","sequence":"additional","affiliation":[{"name":"Medical Affairs, Relypsa, Inc., a Vifor Pharma Group Company; and"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pablo E.","family":"Pergola","sequence":"additional","affiliation":[{"name":"Renal Associates, PA, San Antonio, Texas"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"276","published-online":{"date-parts":[[2018,10,31]]},"reference":[{"key":"B3-20230813","doi-asserted-by":"crossref","first-page":"151","DOI":"10.1001\/jama.2015.7446","article-title":"Effect of patiromer on serum potassium 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