UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Association between chronic kidney disease and aortic calcification burden in urolithiasis patients
Title of the study (Brief title)	Characteristics of aortic calcification and renal function in Urolithiasis patients
Region	Japan

Condition
Condition	Urolithiasis, chronic kidney disease
Classification by specialty	Nephrology Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the clinical relevance of aortic calcification in urolithiasis patients.
Basic objectives2	Others
Basic objectives -Others	Association between chronic kidney disease and aortic calcification burden in urolithiasis patients
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Characteristics of aortic calcification in Urolithiasis patients
Key secondary outcomes	Characteristics of renal function in Urolithiasis patients

Base
Study type	Others,meta-analysis etc

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	20 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Urolithiasis patients with surgical treatment.
Key exclusion criteria	Urolithiasis patients without blood test and stone analysis.
Target sample size	300

Research contact person
Name of lead principal investigator	Shingo Hatakeyama
Organization	Hirosaki University Graduate School of Medicine
Division name	Urology
Address	5 Zaifu
TEL	+81172395091
Email	shingorilla2@gmail.com

Public contact
Name of contact person	Shingo Hatakeyama
Organization	Hirosaki University Graduate School of Medicine
Division name	Urology
Address	+81-172395091
TEL	0172-39-5091
Homepage URL
Email	shingorilla2@gmail.com

Sponsor
Institute	Hirosaki University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Oyokyo Kidney research insttute
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor	Oyokyo Kidney research insttute
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	2016 Year 07 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 01 Day
Anticipated trial start date	2014 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Age, body mass index, aortic calcification index (ACI), renal function, serum uric acid concentrations, and comorbidities (diabetes, hypertension, or cardiovascular disease) were investigated in urolithiasis patients

Management information
Registered date	2016 Year 07 Month 01 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=R000026468