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Methods: In this 24\u2010week, multicentre, open\u2010label, randomized (1 : 1) trial, we assigned hyperuricaemic patients with diabetic nephropathy (estimated glomerular filtration rate\u2009\u2265\u200920\u2009mL/min per 1.73m2) and overt proteinuria (0.3\u2009\u2264\u2009urine protein to creatinine ratio (UPCR) \u003c3.5\u2009g/g\u2009Cr) to either high dose (160\u2009mg daily) or low dose (40\u2009mg daily) topiroxostat. The primary endpoint was the change in albuminuria indicated by urine albumin\u2010to\u2010creatinine ratio (UACR) from the baseline at the final time point. Results: A total of 80 patients underwent randomization. The changes in UACR after 24\u2009weeks of treatment (or at the final time point if patients failed to reach 24\u2009weeks) relative to the baseline were \u2212122\u2009mg/gCr (95% CI: \u22125.1 to \u2212240.1, P\u2009=\u20090.041) in patients treated with high dose, while treatment with low dose topiroxostat could not show significant reduction (P\u2009=\u20090.067). In the linear mixed model including baseline albuminuria, eGFR, age, and sex as covariates, the decreases in UACR were still significant from baseline to 12\u2009weeks by 228.7\u2009\u00b1\u200983.2\u2009mg/gCr (P\u2009=\u20090.0075) in the high dose group. The adverse\u2010event profile during this study was not different between the groups. Conclusion: Topiroxostat 160\u2009mg daily reduced albuminuria in patients with diabetic nephropathy. (Funded by Sanwa Kagaku Kenkyusho; Trial registration, UMIN000015403). 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(2018), Renoprotective effects of topiroxostat for Hyperuricaemic patients with overt diabetic nephropathy study (ETUDE study): A prospective, randomized, multicentre clinical trial. Nephrology, 23: 1023-1030. doi:10.1111/nep.13177], which has been published in final form at [https://doi.org/10.1111/nep.13177]. 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Renoprotective effects of topiroxostat for Hyperuricaemic patients with overt diabetic nephropathy study (ETUDE study): A prospective, randomized, multicentre clinical trial
http://hdl.handle.net/2237/00029282
ba481603-ad8e-4320-b2fb-ced549ecdd4a
名前 / ファイル | ライセンス | アクション | |
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Item type | 学術雑誌論文 / Journal Article(1) | |||||
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公開日 | 2019-02-13 | |||||
タイトル | ||||||
タイトル | Renoprotective effects of topiroxostat for Hyperuricaemic patients with overt diabetic nephropathy study (ETUDE study): A prospective, randomized, multicentre clinical trial | |||||
著者 |
Mizukoshi, Toshihiro
× Mizukoshi, Toshihiro× Kato, Sawako× Ando, Masahiko× Sobajima, Hiroshi× Ohashi, Norimi× Naruse, Tomohiko× Saka, Yosuke× Shimizu, Hideaki× Nagata, Takanobu× Maruyama, Shoichi |
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権利 | ||||||
権利情報 | "This is the peer reviewed version of the following article: [Mizukoshi, T. , Kato, S. , Ando, M. , Sobajima, H. , Ohashi, N. , Naruse, T. , Saka, Y. , Shimizu, H. , Nagata, T. and Maruyama, S. (2018), Renoprotective effects of topiroxostat for Hyperuricaemic patients with overt diabetic nephropathy study (ETUDE study): A prospective, randomized, multicentre clinical trial. Nephrology, 23: 1023-1030. doi:10.1111/nep.13177], which has been published in final form at [https://doi.org/10.1111/nep.13177]. This article may be used for non-commercial purposes in accordance with Wiley Terms and Conditions for Use of Self-Archived Versions." | |||||
キーワード | ||||||
主題Scheme | Other | |||||
主題 | albuminuria | |||||
キーワード | ||||||
主題Scheme | Other | |||||
主題 | diabetic nephropathy | |||||
キーワード | ||||||
主題Scheme | Other | |||||
主題 | randomized study | |||||
キーワード | ||||||
主題Scheme | Other | |||||
主題 | topiroxostat | |||||
キーワード | ||||||
主題Scheme | Other | |||||
主題 | xanthine oxidoreductase inhibitor | |||||
抄録 | ||||||
内容記述 | Aim: We aimed to evaluate the anti‐albuminuric effects of topiroxostat in Japanese hyperuricaemic patients with diabetic nephropathy. Methods: In this 24‐week, multicentre, open‐label, randomized (1 : 1) trial, we assigned hyperuricaemic patients with diabetic nephropathy (estimated glomerular filtration rate ≥ 20 mL/min per 1.73m2) and overt proteinuria (0.3 ≤ urine protein to creatinine ratio (UPCR) <3.5 g/g Cr) to either high dose (160 mg daily) or low dose (40 mg daily) topiroxostat. The primary endpoint was the change in albuminuria indicated by urine albumin‐to‐creatinine ratio (UACR) from the baseline at the final time point. Results: A total of 80 patients underwent randomization. The changes in UACR after 24 weeks of treatment (or at the final time point if patients failed to reach 24 weeks) relative to the baseline were −122 mg/gCr (95% CI: −5.1 to −240.1, P = 0.041) in patients treated with high dose, while treatment with low dose topiroxostat could not show significant reduction (P = 0.067). In the linear mixed model including baseline albuminuria, eGFR, age, and sex as covariates, the decreases in UACR were still significant from baseline to 12 weeks by 228.7 ± 83.2 mg/gCr (P = 0.0075) in the high dose group. The adverse‐event profile during this study was not different between the groups. Conclusion: Topiroxostat 160 mg daily reduced albuminuria in patients with diabetic nephropathy. (Funded by Sanwa Kagaku Kenkyusho; Trial registration, UMIN000015403). | |||||
内容記述タイプ | Abstract | |||||
内容記述 | ||||||
内容記述 | ファイル公開:2019-11-01 | |||||
内容記述タイプ | Other | |||||
出版者 | ||||||
出版者 | Wiley | |||||
言語 | ||||||
言語 | eng | |||||
資源タイプ | ||||||
資源タイプresource | http://purl.org/coar/resource_type/c_6501 | |||||
タイプ | journal article | |||||
DOI | ||||||
関連識別子 | ||||||
識別子タイプ | DOI | |||||
関連識別子 | https://doi.org/10.1111/nep.13177 | |||||
ISSN(print) | ||||||
収録物識別子タイプ | ISSN | |||||
収録物識別子 | 1320-5358 | |||||
書誌情報 |
Nephrology 巻 23, 号 11, p. 1023-1030, 発行日 2018-11 |
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著者版フラグ | ||||||
値 | author |