Effects of sodium-glucose co-transporter 2 inhibitors on ultrafiltration in patients with peritoneal dialysis: a protocol for a randomized, double-blind, placebo-controlled, crossover trial (EMPOWERED)

Doi, Yohei; Shinzawa, Maki; Arisato, Tetsuya; Oka, Hideaki; Matsumoto, Ayumi; Kitamura, Harumi; Nakazono, Yumi; Nishiya, Yoichi; Ueda, Yoshiyasu; Kamimura, Taro; Hayashi, Terumasa; Yoshihara, Fumiki; Isaka, Yoshitaka

doi:https://doi.org/10.1007/s10157-024-02467-w

Effects of sodium-glucose co-transporter 2 inhibitors on ultrafiltration in patients with peritoneal dialysis: a protocol for a randomized, double-blind, placebo-controlled, crossover trial (EMPOWERED)

Doi, Yohei; Shinzawa, Maki; Arisato, Tetsuya et al.

Clinical and Experimental Nephrology, 2024, 28, 629-635

Number of Access:1,308（2025-09-12 06:38 Counts）

Identifier to cite or link to this item: https://hdl.handle.net/11094/95017

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Title	Effects of sodium-glucose co-transporter 2 inhibitors on ultrafiltration in patients with peritoneal dialysis: a protocol for a randomized, double-blind, placebo-controlled, crossover trial (EMPOWERED)
Creator	NRID 1000030846382 1000030846382 ORCID 0000-0002-5165-291X 0000-0002-5165-291X researchmap permalink DOI-YOHEI DOI-YOHEI CreatorName Doi, Yohei
	NRID 1000030704788 1000030704788 researchmap permalink 7000009447 7000009447 Scopus Author ID 47661817400 47661817400 CreatorName Shinzawa, Maki
	CreatorName Arisato, Tetsuya
	CreatorName Oka, Hideaki
	NRID 1000040794053 1000040794053 CreatorName Matsumoto, Ayumi
	NRID 1000060570356 1000060570356 researchmap permalink kitamura3857 kitamura3857 Scopus Author ID 24334934300 24334934300 CreatorName Kitamura, Harumi
	CreatorName Nakazono, Yumi
	CreatorName Nishiya, Yoichi
	CreatorName Ueda, Yoshiyasu
	CreatorName Kamimura, Taro
	CreatorName Hayashi, Terumasa
	NRID 1000070393220 1000070393220 CreatorName Yoshihara, Fumiki
	NRID 1000000379166 1000000379166 researchmap permalink isaka-handai3857 isaka-handai3857 Scopus Author ID 16207611100 16207611100 ORCID 0000-0002-0820-7167 0000-0002-0820-7167 CreatorName Isaka, Yoshitaka
Subject	Peritoneal dialysis
	SGLT2 inhibitor
	Ultrafiltration
	Volume overload
Description	The version of record of this article, first published in Clinical and Experimental Nephrology, is available online at Publisher’s website: https://doi.org/10.1007/s10157-024-02467-w.
Abstract	Background: Volume overload is common and associated with high mortality in patients on peritoneal dialysis (PD). Traditional strategies including diuretics, water/salt restriction, and icodextrin-based solutions cannot always fully correct this condition, necessitating novel alternative strategies. Recent studies confirmed the expression of sodium–glucose cotransporter 2 (SGLT2) in the human peritoneum. Experimental data suggest that SGLT2 inhibitors decrease glucose absorption from the PD solution, thereby increasing the ultrafiltration volume. This trial aims to assess whether SGLT2 inhibitors increase the ultrafiltration volume in patients on PD. Methods: The EMPOWERED trial (trial registration: jRCTs051230081) is a multicenter, randomized, double-blind, placebo-controlled, crossover trial. Patients with clinically diagnosed chronic heart failure are eligible regardless of the presence of diabetes if they use at least 3 L/day glucose-based PD solutions. Participants will be randomly assigned (1:1) to receive empagliflozin 10 mg once daily and then placebo or vice versa. Each treatment period will last 8 weeks with a 4-week washout period. This study will recruit at least 36 randomized participants. The primary endpoint is the change in the daily ultrafiltration volume from baseline to week 8 in each intervention period. The key secondary endpoints include changes in the biomarkers of drained PD solutions, renal residual function, and anemia-related parameters. Conclusions: This trial aims to assess the benefit of SGLT2 inhibitors in fluid management with a novel mechanism of action in patients on PD. It will also provide insights into the effects of SGLT2 inhibitors on solute transport across the peritoneal membrane and residual renal function.
Publisher	Springer
Source Title	Clinical and Experimental Nephrology
Volume (Issue)	28
Page	629-635
Date of Issued	2024-02-25
Language	English
Handle URL	https://hdl.handle.net/11094/95017
PISSN	13421751
eISSN	14377799
Relation.isIdenticalTo	DOI (Publisher Version) https://doi.org/10.1007/s10157-024-02467-w
Access Rights	open access
CopyRight	This article is licensed under a Creative Commons Attribution 4.0 International License.
oaire:version	Version of Record
Category	学術雑誌論文 Journal Article

Resource Type	journal article
Local Type	Journal Article
DCMI Type	Text
DCTERMS.bibliographicCitation	Clinical and Experimental Nephrology. 2024, 28, p. 629-635
DC.title	Effects of sodium-glucose co-transporter 2 inhibitors on ultrafiltration in patients with peritoneal dialysis: a protocol for a randomized, double-blind, placebo-controlled, crossover trial (EMPOWERED)
DC.creator	Doi, Yohei
	Shinzawa, Maki
	Arisato, Tetsuya
	Oka, Hideaki
	Matsumoto, Ayumi
	Kitamura, Harumi
	Nakazono, Yumi
	Nishiya, Yoichi
	Ueda, Yoshiyasu
	Kamimura, Taro
	Hayashi, Terumasa
	Yoshihara, Fumiki
	Isaka, Yoshitaka
DC.publisher	Springer
DC.language' scheme='DCTERMS.RFC1766	English
DC.type' scheme='DCTERMS.DCMIType	Text
DCTERMS.issued' scheme='DCTERMS.W3CDTF	2024-02-25
DC.identifier	https://doi.org/10.1007/s10157-024-02467-w
DC.subject	Peritoneal dialysis
	SGLT2 inhibitor
	Ultrafiltration
	Volume overload
DC.description	The version of record of this article, first published in Clinical and Experimental Nephrology, is available online at Publisher’s website: https://doi.org/10.1007/s10157-024-02467-w.
DCTERMS.abstract	Background: Volume overload is common and associated with high mortality in patients on peritoneal dialysis (PD). Traditional strategies including diuretics, water/salt restriction, and icodextrin-based solutions cannot always fully correct this condition, necessitating novel alternative strategies. Recent studies confirmed the expression of sodium–glucose cotransporter 2 (SGLT2) in the human peritoneum. Experimental data suggest that SGLT2 inhibitors decrease glucose absorption from the PD solution, thereby increasing the ultrafiltration volume. This trial aims to assess whether SGLT2 inhibitors increase the ultrafiltration volume in patients on PD. Methods: The EMPOWERED trial (trial registration: jRCTs051230081) is a multicenter, randomized, double-blind, placebo-controlled, crossover trial. Patients with clinically diagnosed chronic heart failure are eligible regardless of the presence of diabetes if they use at least 3 L/day glucose-based PD solutions. Participants will be randomly assigned (1:1) to receive empagliflozin 10 mg once daily and then placebo or vice versa. Each treatment period will last 8 weeks with a 4-week washout period. This study will recruit at least 36 randomized participants. The primary endpoint is the change in the daily ultrafiltration volume from baseline to week 8 in each intervention period. The key secondary endpoints include changes in the biomarkers of drained PD solutions, renal residual function, and anemia-related parameters. Conclusions: This trial aims to assess the benefit of SGLT2 inhibitors in fluid management with a novel mechanism of action in patients on PD. It will also provide insights into the effects of SGLT2 inhibitors on solute transport across the peritoneal membrane and residual renal function.
DC.rights	This article is licensed under a Creative Commons Attribution 4.0 International License.
DC.format	95017
citation_title	Effects of sodium-glucose co-transporter 2 inhibitors on ultrafiltration in patients with peritoneal dialysis: a protocol for a randomized, double-blind, placebo-controlled, crossover trial (EMPOWERED)
citation_author	Doi, Yohei
	Shinzawa, Maki
	Arisato, Tetsuya
	Oka, Hideaki
	Matsumoto, Ayumi
	Kitamura, Harumi
	Nakazono, Yumi
	Nishiya, Yoichi
	Ueda, Yoshiyasu
	Kamimura, Taro
	Hayashi, Terumasa
	Yoshihara, Fumiki
	Isaka, Yoshitaka
citation_publisher	Springer
citation_language	English
citation_date	2024-02-25
citation_journal_title	Clinical and Experimental Nephrology
citation_volume	28
citation_firstpage	629
citation_lastpage	635
citation_doi	https://doi.org/10.1007/s10157-024-02467-w
citation_public_url	https://hdl.handle.net/11094/95017

Effects of sodium-glucose co-transporter 2 inhibitors on ultrafiltration in patients with peritoneal dialysis: a protocol for a randomized, double-blind, placebo-controlled, crossover trial (EMPOWERED)

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