神戸大学附属図書館デジタルアーカイブ
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https://hdl.handle.net/20.500.14094/90005063
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2024-04-27
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90005063 (fulltext)
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メタデータID
90005063
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open access
出版タイプ
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タイトル
Rationale, design, and characteristics of a trial to evaluate the new phosphate iron-based binder sucroferric oxyhydroxide in dialysis patients with the goal of advancing the practice of E.B.M. (EPISODE)
著者
Isaka, Yoshitaka ; Fujii, Hideki ; Tsujimoto, Yoshihiro ; Teramukai, Satoshi ; Hamano, Takayuki
著者名
Isaka, Yoshitaka
著者ID
A1419
研究者ID
1000060416211
KUID
https://kuid-rm-web.ofc.kobe-u.ac.jp/search/detail?systemId=b4267c0476708bc0520e17560c007669
著者名
Fujii, Hideki
藤井, 秀毅
フジイ, ヒデキ
所属機関名
医学部附属病院
著者名
Tsujimoto, Yoshihiro
著者名
Teramukai, Satoshi
著者名
Hamano, Takayuki
収録物名
Clinical and Experimental Nephrology
巻(号)
22(4)
ページ
967-972
出版者
Springer
刊行日
2018-08
公開日
2018-07-25
抄録
Background: In dialysis patients, mortality risk due to cardiovascular diseases is remarkably high and prognosis is poor; coronary artery calcification is considered one of the major contributing factors. It is known that hyperphosphatemia is associated with coronary artery calcification. Therefore, controlling serum phosphate level and thereby mitigating vascular calcification could improve the poor prognosis of dialysis patients. However, the optimal phosphate level in dialysis patients remains unknown; hence, this study was planned to compare the effects of two types of non-calcium-based phosphate binders, and examine the effect of strict control of phosphate on coronary artery calcification. Methods: EPISODE is a randomized, open-label, multi-center, interventional trial with a two-by-two factorial design (UMIN ID: UMIN000023648). This trial will enroll hemodialysis patients who have been on dialysis for at least 3 months with a pre-dialysis serum phosphate level of at least 5.0 mg/dL or at least 6.1 mg/dL, respectively, in those taking or not taking a phosphate binder, as measured during the observation period. Registered patients will be randomized to the sucroferric oxyhydroxide or lanthanum carbonate arm and will receive the assigned drug to reduce serum phosphate to two target levels (3.5-4.5 mg/dL in strict arm and 5.0-6.0 mg/dL in standard arm) for 12 months. The primary endpoint will be percent change in coronary artery calcification score, and the secondary endpoints will include change from baseline serum phosphate and calcium levels, change in renal anemia-related factors, etc. The desired sample size has been calculated to be 200 patients.
キーワード
Hyperphosphatemia
Dialysis patient
Coronary artery calcification score
Multi-detector computed tomography
Phosphate binder
カテゴリ
医学部附属病院
学術雑誌論文
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© The Author(s) 2018.
This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.
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資源タイプ
journal article
言語
English (英語)
ISSN
1342-1751
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eISSN
1437-7799
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関連情報
DOI
https://doi.org/10.1007/s10157-018-1547-5
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