UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028050
Receipt number 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 09:20:46

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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

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

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 or person

Institute

Oyokyo Kidney Research Institute

Institute

Department

Personal name



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

Value
https://center6.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