UMIN-CTR Clinical Trial

Basic information
Public title	Association between vascular calcification and exostosin-like glycosaminotransferase 2 (EXTL2) in hemodialysis patients
Acronym	Association between vascular calcification and EXTL2
Scientific Title	Association between vascular calcification and exostosin-like glycosaminotransferase 2 (EXTL2) in hemodialysis patients
Scientific Title:Acronym	Association between vascular calcification and EXTL2
Region	Japan

Condition
Condition	Chronic Kidney Disease
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate whether EXTL2 is associated with vascular calcification in hemodialysis patients
Basic objectives2	Others
Basic objectives -Others	Association between EXTL2 and vascular calcification
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Association between EXTL2 and abdominal calcification index (ACI)
Key secondary outcomes	1, Association between EXTL2 and chondroitin sulfate or heparan sulfate 2, Association between serum EXTL2 levels and EXTL2 mRNA in blood 3, Association between EXTL2 and other parameters 4, Difference of serum EXTL2 levels between healthy control and hemodialysis patients 5, Association between vascular calcification and chondroitin sulfate or heparan sulfate

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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	hemodialysis patients
Key exclusion criteria	1, Inpatients 2, Patients who started hemodialysis within 6 months 3, Diabetic patients 4, Patients whose diameter of abdominal aorta is over three centimeters 5, Patients with surgical history of abdominal aorta 6, Patients who do not agree with participation in this study
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shunsuke Goto
Organization	Kobe University Graduate School of Medicine
Division name	Division of Nephrology and Kidney Center
Zip code
Address	7-5-2, Kusuhoki-cho, Chuo-ku, Kobe, Japan
TEL	078-382-6500
Email	sgoto@med.kobe-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Shunsuke Goto
Organization	Kobe University Graduate School of Medicine
Division name	Division of Nephrology and Kidney Center
Zip code
Address	7-5-2, Kusuhoki-cho, Chuo-ku, Kobe, Japan
TEL	078-382-6500
Homepage URL
Email	sgoto@med.kobe-u.ac.jp

Sponsor
Institute	Division of Nephrology and Kidney Center, Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Japanese Association of Dialysis Physicians
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	社会医療法人愛仁会千船病院（大阪府）

Other administrative information
Date of disclosure of the study information	2015 Year 06 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	27
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	We require time to complete the paper.
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 04 Day
Date of IRB	2015 Year 06 Month 03 Day
Anticipated trial start date	2015 Year 06 Month 15 Day
Last follow-up date	2015 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Prospective study

Management information
Registered date	2015 Year 06 Month 11 Day
Last modified on	2020 Year 06 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018730