{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,10]],"date-time":"2026-07-10T02:01:52Z","timestamp":1783648912451,"version":"3.55.0"},"reference-count":27,"publisher":"BMJ","issue":"3","license":[{"start":{"date-parts":[[2025,3,3]],"date-time":"2025-03-03T00:00:00Z","timestamp":1740960000000},"content-version":"unspecified","delay-in-days":2,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100020869","name":"AstraZeneca KK","doi-asserted-by":"publisher","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}],"id":[{"id":"10.13039\/100020869","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,2,14]]},"published-print":{"date-parts":[[2025,3]]},"abstract":"<jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>To effectively manage the progression of diabetic kidney disease, it is essential to address the associated hyperkalaemia while concurrently using renin-angiotensin-aldosterone system inhibitors and mineralocorticoid receptor antagonists. In this study, we aim to evaluate the effects of administering sodium zirconium cyclosilicate (SZC) to patients with type 2 diabetes mellitus (T2DM) complicated by hyperkalaemia.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods and analysis<\/jats:title>\n                  <jats:p>A total of 80 patients with type 2 diabetes and hyperkalaemia will be included in the study and randomly stratified into two groups.<\/jats:p>\n                  <jats:p>After consent, both groups will enter an initiation phase, receiving 10\u2009g of SZC, three times per day for 2\u2009days. SZC administration (5\u2009g once daily) will subsequently commence in group A, while dietary therapy will be initiated in group B by implementing a potassium-restricted diet. The primary endpoint of the study is the proportion of normokalaemic (3.5 mEq\/L\u2264serum potassium (sK)&lt;5.0\u2009mEq\/L) participants at visit 7. The secondary endpoints are: (a) the proportion of normokalaemic participants (3.5 mEq\/L\u2264sK&lt;5.0\u2009mEq\/L) at visit 4 and (b) serum potassium levels at visit 7.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Ethics and dissemination<\/jats:title>\n                  <jats:p>Written informed consent will be obtained from all participants prior to commencing the study. This study has been approved by the Kyoto Prefectural University of Medicine Clinical Research Review Board. All data obtained from this study will be published in a peer-reviewed journal.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Trial registration number<\/jats:title>\n                  <jats:p>jRCTs051230067.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1136\/bmjopen-2024-089564","type":"journal-article","created":{"date-parts":[[2025,3,3]],"date-time":"2025-03-03T16:55:48Z","timestamp":1741020948000},"page":"e089564","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":2,"title":["Non-inferiority of sodium zirconium cyclosilicate versus potassium-restricted diet in achieving normokalaemia in patients with type 2 diabetes mellitus: protocol for a multicentre, open-label, randomised controlled, two-arm clinical trial (SILVERSTAR study)"],"prefix":"10.1136","volume":"15","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2970-5333","authenticated-orcid":false,"given":"Junya","family":"Hironaka","sequence":"first","affiliation":[{"name":"Department of Endocrinology and Metabolism, Kyoto Prefectural University of Medicine School of Medicine Graduate School of Medical Science, Kyoto, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1707-970X","authenticated-orcid":false,"given":"Hiroshi","family":"Okada","sequence":"additional","affiliation":[{"name":"Department of Endocrinology and Metabolism, Kyoto Prefectural University of Medicine School of Medicine Graduate School of Medical Science, Kyoto, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takafumi","family":"Osaka","sequence":"additional","affiliation":[{"name":"Ayabe City Hospital, Ayabe, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8794-0550","authenticated-orcid":false,"given":"Yoshitaka","family":"Hashimoto","sequence":"additional","affiliation":[{"name":"Matsushita Memorial Hospital, Moriguchi, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Genki","family":"Kobayashi","sequence":"additional","affiliation":[{"name":"Aiseikai Ymashina Hospital, Kyoto, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Muhei","family":"Tanaka","sequence":"additional","affiliation":[{"name":"Shiritsu Suita Shimin Byoin, Suita, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akinori","family":"Kogure","sequence":"additional","affiliation":[{"name":"Department of Diabetes and Metabolic Medicine, Kyoto City Hospital, Kyoto, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kazuteru","family":"Mitsuhashi","sequence":"additional","affiliation":[{"name":"Department of Diabetes Internal Medicine, Fukuchiyama City Hospital, Fukuchiyama, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takashi","family":"Yoshimura","sequence":"additional","affiliation":[{"name":"Akashi City Hospital, Akashi, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3263-9469","authenticated-orcid":false,"given":"Noriyuki","family":"Kitagawa","sequence":"additional","affiliation":[{"name":"Department of Diabetology, Kameoka Municipal Hospital, Kameoka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miho","family":"Yano","sequence":"additional","affiliation":[{"name":"Department of Diabetology, Nishijin Hospital, Kyoto, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akane","family":"Kitamura","sequence":"additional","affiliation":[{"name":"Department of Diabetology, Nagitsuji Hospital, Kyoto, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Akio","family":"Kishi","sequence":"additional","affiliation":[{"name":"Department of Diabetes, Kyoto Okamoto Memorial Hospital, Kuze-gun, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takeshi","family":"Tsutsumi","sequence":"additional","affiliation":[{"name":"Kyoto Yamashiro General Medical Center, Kizugawa, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masahiro","family":"Yamazaki","sequence":"additional","affiliation":[{"name":"Kyoto Second Red Cross Hospital, Kyoto, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michiyo","family":"Ishii","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Otsu City Hospital, Otsu, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shinichi","family":"Mogami","sequence":"additional","affiliation":[{"name":"Department of Endocrinology, Metabolism, and Diabetes, Saiseikai Suita Hospital, Osaka, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naoto","family":"Nakamura","sequence":"additional","affiliation":[{"name":"Kyoto Saiseikai Hospital, Nagaokakyo, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takuya","family":"Fukuda","sequence":"additional","affiliation":[{"name":"Amanogawa Hospital, Kishiwada, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toru","family":"Tanaka","sequence":"additional","affiliation":[{"name":"Japanese Red Cross Kyoto Daiichi Hospital, Kyoto, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryo","family":"Bamba","sequence":"additional","affiliation":[{"name":"Kyoto Chubu Medical Center, Nantan, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eiko","family":"Sato","sequence":"additional","affiliation":[{"name":"Ashikaga University, Ashikaga, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8651-4445","authenticated-orcid":false,"given":"Masahide","family":"Hamaguchi","sequence":"additional","affiliation":[{"name":"Department of Diabetology, Kameoka Municipal Hospital, Kameoka, Japan"},{"name":"Department of Endocrinology and Metabolism, Kyoto Prefectural University of Medicine, Kyoto, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0903-1797","authenticated-orcid":false,"given":"Michiaki","family":"Fukui","sequence":"additional","affiliation":[{"name":"Department of Endocrinology and Metabolism, Kyoto Prefectural University of Medicine School of Medicine Graduate School of Medical Science, Kyoto, Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2025,3,3]]},"reference":[{"key":"2025101815131371000_15.3.e089564.1","doi-asserted-by":"publisher","DOI":"10.1007\/s00125-010-1922-6"},{"key":"2025101815131371000_15.3.e089564.2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2011.1967"},{"key":"2025101815131371000_15.3.e089564.3","doi-asserted-by":"crossref","first-page":"681","DOI":"10.1093\/eurheartj\/ehaa1012","article-title":"Heart failure drug treatment: the fantastic four","volume":"42","author":"Bauersachs","year":"2021","journal-title":"Eur Heart J"},{"key":"2025101815131371000_15.3.e089564.4","unstructured":"The Japan Diabetes Society . Diabetes mellitus treatment guideline 2024. Nankodo; 2019."},{"key":"2025101815131371000_15.3.e089564.5","doi-asserted-by":"crossref","first-page":"347","DOI":"10.1001\/jamainternmed.2013.12700","article-title":"Renoprotective effect of renin-angiotensin-aldosterone system blockade in patients with predialysis advanced chronic kidney disease, hypertension, and anemia","volume":"174","author":"Hsu","year":"2014","journal-title":"JAMA Intern Med"},{"key":"2025101815131371000_15.3.e089564.6","doi-asserted-by":"publisher","DOI":"10.1053\/j.ajkd.2018.08.013"},{"key":"2025101815131371000_15.3.e089564.7","doi-asserted-by":"crossref","first-page":"1019","DOI":"10.2215\/CJN.0000000000000205","article-title":"Influence of SGLT2i and RAASi and Their Combination on Risk of Hyperkalemia in DKD: A Network Meta-Analysis","volume":"18","author":"Luo","year":"2023","journal-title":"Clin J Am Soc Nephrol"},{"key":"2025101815131371000_15.3.e089564.8","doi-asserted-by":"crossref","first-page":"117","DOI":"10.1016\/j.kint.2023.10.018","article-title":"KDIGO 2024 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease","volume":"105","year":"2024","journal-title":"Kidney Int"},{"key":"2025101815131371000_15.3.e089564.9","unstructured":"Japanese Society of Nephrology . Evidence-based ckd guideline 2018. Tokyo Igakusha; 2018."},{"key":"2025101815131371000_15.3.e089564.10","doi-asserted-by":"publisher","DOI":"10.2215\/CJN.05850809"},{"key":"2025101815131371000_15.3.e089564.11","doi-asserted-by":"publisher","DOI":"10.1001\/archinternmed.2009.132"},{"key":"2025101815131371000_15.3.e089564.12","doi-asserted-by":"publisher","DOI":"10.1159\/000437151"},{"key":"2025101815131371000_15.3.e089564.13","doi-asserted-by":"publisher","DOI":"10.2215\/CJN.01730215"},{"key":"2025101815131371000_15.3.e089564.14","doi-asserted-by":"publisher","DOI":"10.1161\/CIRCHEARTFAILURE.109.899526"},{"key":"2025101815131371000_15.3.e089564.15","doi-asserted-by":"publisher","DOI":"10.1159\/000329511"},{"key":"2025101815131371000_15.3.e089564.16","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0067140","article-title":"Hypokalemia, its contributing factors and renal outcomes in patients with chronic kidney disease","volume":"8","author":"Wang","year":"2013","journal-title":"PLoS One"},{"key":"2025101815131371000_15.3.e089564.17","unstructured":"Japanese Society of Nephrology . Standard of diet therapy for chronic kidney disease 2014. Igakusha; 2014."},{"key":"2025101815131371000_15.3.e089564.18","doi-asserted-by":"publisher","DOI":"10.2337\/diacare.27.6.1271"},{"key":"2025101815131371000_15.3.e089564.19","doi-asserted-by":"publisher","DOI":"10.1017\/S1368980011000504"},{"key":"2025101815131371000_15.3.e089564.20","doi-asserted-by":"publisher","DOI":"10.3109\/00365529309098272"},{"key":"2025101815131371000_15.3.e089564.21","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2014.15688"},{"key":"2025101815131371000_15.3.e089564.22","first-page":"54","article-title":"Efficacy and safety of sodium zirconium cyclosilicate for hyperkalaemia: the randomized, placebo-controlled HARMONIZE-Global study","volume":"7","author":"Zannad","year":"2020","journal-title":"ESC Heart Fail"},{"key":"2025101815131371000_15.3.e089564.23","doi-asserted-by":"publisher","DOI":"10.2215\/CJN.00670117"},{"key":"2025101815131371000_15.3.e089564.24","doi-asserted-by":"crossref","first-page":"276","DOI":"10.1053\/j.jrn.2019.09.009","article-title":"Effect of Dietary Potassium Restriction on Serum Potassium, Disease Progression, and Mortality in Chronic Kidney Disease: A Systematic Review and Meta-Analysis","volume":"30","author":"Morris","year":"2020","journal-title":"J Ren Nutr"},{"key":"2025101815131371000_15.3.e089564.25","unstructured":"Clase CM , Carrero JJ , Ellison DH , et al . Potassium homeostasis and management of dyskalemia in kidney diseases: conclusions from a kidney disease. Improving Global Outcomes (KDIGO) Controversies Conference; 2020:42\u201361."},{"key":"2025101815131371000_15.3.e089564.26","doi-asserted-by":"crossref","first-page":"1948","DOI":"10.3390\/nu10121948","article-title":"Intakes of Zinc, Potassium, Calcium, and Magnesium of Individuals with Type 2 Diabetes Mellitus and the Relationship with Glycemic Control","volume":"10","author":"Brand\u00e3o-Lima","year":"2018","journal-title":"Nutrients"},{"key":"2025101815131371000_15.3.e089564.27","doi-asserted-by":"crossref","first-page":"476","DOI":"10.1016\/j.xkme.2020.04.007","article-title":"Impact of Dietary Potassium Restrictions in CKD on Clinical Outcomes: Benefits of a Plant-Based Diet","volume":"2","author":"Clegg","year":"2020","journal-title":"Kidney Med"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2024-089564","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,18]],"date-time":"2025-10-18T22:13:21Z","timestamp":1760825601000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2024-089564"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,3]]},"references-count":27,"journal-issue":{"issue":"3","published-online":{"date-parts":[[2025,3,3]]},"published-print":{"date-parts":[[2025,3]]}},"alternative-id":["10.1136\/bmjopen-2024-089564"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2024-089564","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,3]]}}}