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)

被引：0

作者：

Hironaka, Junya ^{[1
]}

Okada, Hiroshi ^{[1
]}

Osaka, Takafumi ^{[2
]}

Hashimoto, Yoshitaka ^{[3
]}

Kobayashi, Genki ^{[4
]}

Tanaka, Muhei ^{[5
]}

Kogure, Akinori ^{[6
]}

Mitsuhashi, Kazuteru ^{[7
]}

Yoshimura, Takashi ^{[8
]}

Kitagawa, Noriyuki ^{[9
]}

Yano, Miho ^{[10
]}

Kitamura, Akane ^{[11
]}

Kishi, Akio ^{[12
]}

Tsutsumi, Takeshi ^{[13
]}

Yamazaki, Masahiro ^{[14
]}

Ishii, Michiyo ^{[15
]}

Mogami, Shinichi ^{[16
]}

Nakamura, Naoto ^{[17
]}

Fukuda, Takuya ^{[18
]}

Tanaka, Toru ^{[19
]}

Bamba, Ryo ^{[20
]}

Sato, Eiko ^{[21
]}

Hamaguchi, Masahide ^{[9
,22
]}

Fukui, Michiaki ^{[1
]}

机构：

[1] Kyoto Prefectural Univ Med, Sch Med, Grad Sch Med Sci, Dept Endocrinol & Metab, Kyoto, Japan

[2] Ayabe City Hosp, Ayabe, Japan

[3] Matsushita Mem Hosp, Moriguchi, Japan

[4] Aiseikai Ymashina Hosp, Kyoto, Japan

[5] Shiritsu Suita Shimin Byoin, Suita, Osaka, Japan

[6] Kyoto City Hosp, Dept Diabet & Metab Med, Kyoto, Japan

[7] Fukuchiyama City Hosp, Dept Internal Med, Fukuchiyama, Japan

[8] Akashi City Hosp, Akashi, Hyogo, Japan

[9] Kameoka Municipal Hosp, Dept Diabetol, Kameoka, Japan

[10] Nishijin Hosp, Dept Diabetol, Kyoto, Japan

[11] Nagitsuji Hosp, Dept Diabetol, Kyoto, Japan

[12] Kyoto Okamoto Mem Hosp, Dept Psychiat, Kumiyama, Japan

[13] Kyoto Yamashiro Gen Med Ctr, Kizugawa, Japan

[14] Kyoto Second Red Cross Hosp, Kyoto, Japan

[15] Otsu City Hosp, Dept Internal Med, Otsu, Japan

[16] Saiseikai Suita Hosp, Dept Endocrinol Metab & Diabet, Osaka, Japan

[17] Saiseikai Kyoto Hosp, Nagaokakyo, Japan

[18] Kishiwada City Hosp, Kishiwada, Japan

[19] Japanese Red Cross Kyoto Daiichi Hosp, Kyoto, Japan

[20] Kyoto Chubu Med Ctr, Nantan, Japan

[21] Ashikaga Univ, Ashikaga, Japan

[22] Kyoto Prefectural Univ Med, Dept Endocrinol & Metab, Kyoto, Japan

来源：

BMJ OPEN | 2025年 / 15卷 / 03期

关键词：

Randomised Controlled Trial; Diabetes Mellitus; Type; 2; Chronic renal failure; CHRONIC KIDNEY-DISEASE; QUALITY-OF-LIFE; SERUM POTASSIUM; HEART-FAILURE; OUTCOMES; HYPERKALEMIA; MORTALITY; ASSOCIATION; CKD;

D O I：

10.1136/bmjopen-2024-089564

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Background 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. Methods and analysis A total of 80 patients with type 2 diabetes and hyperkalaemia will be included in the study and randomly stratified into two groups. After consent, both groups will enter an initiation phase, receiving 10 g of SZC, three times per day for 2 days. SZC administration (5 g 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 <= serum potassium (sK)<5.0 mEq/L) participants at visit 7. The secondary endpoints are: (a) the proportion of normokalaemic participants (3.5 mEq/L <= sK<5.0 mEq/L) at visit 4 and (b) serum potassium levels at visit 7. Methods and analysis A total of 80 patients with type 2 diabetes and hyperkalaemia will be included in the study and randomly stratified into two groups. After consent, both groups will enter an initiation phase, receiving 10 g of SZC, three times per day for 2 days. SZC administration (5 g 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 <= serum potassium (sK)<5.0 mEq/L) participants at visit 7. The secondary endpoints are: (a) the proportion of normokalaemic participants (3.5 mEq/L <= sK<5.0 mEq/L) at visit 4 and (b) serum potassium levels at visit 7. Ethics and dissemination 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.

引用

页数：12

共 27 条

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