UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Association between proton pump inhibitors and progression of abdominal aortic calcification in patients on maintenance hemodialysis
Title of the study (Brief title)	Association between proton pump inhibitors and progression of abdominal aortic calcification in patients on maintenance hemodialysis
Region	Japan

Condition
Condition	Chronic kidney disease with maintanace hemodialysis
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aimed to investigate whether the long-term use of PPIs accelerates vascular calcification in patients on HD.
Basic objectives2	Others
Basic objectives -Others	factor
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To clarify the association between long-term PPIs use and progression of aortic calcification in patients with hemodialysis.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	25 years-old <=
Age-upper limit	100 years-old >
Gender	Male and Female
Key inclusion criteria	Between April 2016 and September 2017,patients underwent maintenance HD or hemodiafiltration thrice a week at the Oyokyo Kidney Research Institute, Aomori, Japan.
Key exclusion criteria	Patients with severe aortic calcification, including calcification extending along the entire length and almost entire circumference of the abdominal aorta. Patients who did not undergo abdominal CT Patients who had inappropriate intervals between subsequent CT scans.
Target sample size	200

Research contact person
Name of lead principal investigator	Shingo Hatakeyama
Organization	Hirosaki University Graduate School of Medicine
Division name	Department of Urology
Address	5 Zaifu-chou, Hirosaki 036-8562, Japan
TEL	0172-39-5091
Email	shingoh@hirosaki-u.ac.jp

Public contact
Name of contact person	Teppei Okamoto
Organization	Oyokyo Kidney Research Institute Aomori Hospital
Division name	Department of Urology
Address	101-1 Okabe, Ishie, Aomori 038-0003, Japan
TEL	0177819331
Homepage URL
Email	tepperococcus@yahoo.co.jp

Sponsor
Institute	Oyokyo Kidney Research Institute
Institute
Department

Funding Source
Organization	Hirosaki University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 11 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 30 Day
Anticipated trial start date	2017 Year 09 Month 01 Day
Last follow-up date	2017 Year 10 Month 01 Day
Date of closure to data entry	2017 Year 10 Month 10 Day
Date trial data considered complete	2017 Year 10 Month 15 Day
Date analysis concluded	2017 Year 10 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://doi.org/10.1371/journal.pone.0199160
Results	This study implied that PPIs was the one of independent factors associated with progression of aortic calcification among patients on maintainance HD.
Other related information	Study type:retrospective Observational Study Object: hemodialysis Patients who received abdominal computed tomography in Oyokyo kidney research institute Aomori Hospital from April, 2016 to September, 2017.

Management information
Registered date	2017 Year 11 Month 03 Day
Last modified on	2018 Year 12 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000034065