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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028050
Receipt No. R000032109
Scientific Title The relationship between poor nutritional status and progression of aortic calcification in patients with maintenance hemodialysis
Date of disclosure of the study information 2017/07/06
Last modified on 2018/12/29

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Basic information
Public title The relationship between poor nutritional status and progression of aortic calcification in patients with maintenance hemodialysis
Acronym The relationship between poor nutritional status and progression of aortic calcification in patients with maintenance hemodialysis
Scientific Title The relationship between poor nutritional status and progression of aortic calcification in patients with maintenance hemodialysis
Scientific Title:Acronym The relationship between poor nutritional status and progression of aortic calcification in patients with 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 The aim of this study was to investigate the relationship between malnutrition and aortic calcification progression in patients with hemodialysis.
Basic objectives2 Others
Basic objectives -Others factor
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes To clarify the association between malnutrition 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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria patients who underwent adequate annual abdominal CT
Key exclusion criteria patients with inadequate abdominal computed tomography (CT); CT not available, available only contrast enhanced CT, CT with a 3-mm slice thickness.
patients with severe AC in 2015, inadequate interval (within 10 months) of abdominal computed tomography .
Target sample size 190

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Shingo Hatakeyama
Organization Hirosaki University Graduate School of Medicine
Division name Department of Urology
Zip code
Address 5 Zaifu-chou, Hirosaki 036-8562, Japan
TEL 0172-39-5091
Email shingoh@hirosaki-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Teppei Okamoto
Organization Oyokyo Kidney Research Institute Aomori Hospital
Division name Department of Urology
Zip code
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)

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

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 06 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://doi.org/10.1186/s12882-018-0872-y
Number of participants that the trial has enrolled
Results
This study demonstrated that poor nutritional status was the one of independent factors associated with progression of aortic calcification among CKD patients on HD.
 
Results date posted
Results Delayed
Results Delay Reason
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
2016 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 10 Month 15 Day
Last follow-up date
2016 Year 10 Month 31 Day
Date of closure to data entry
2016 Year 11 Month 01 Day
Date trial data considered complete
2016 Year 11 Month 01 Day
Date analysis concluded
2017 Year 05 Month 30 Day

Other
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, 2015 to October, 2016.

Management information
Registered date
2017 Year 07 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/ctr_e/ctr_view.cgi?recptno=R000032109

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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