UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012341
Receipt number R000014431
Scientific Title Association between nutritional status/vascular calcification and AGEs/proteolysis pathway in hemodialysis patients
Date of disclosure of the study information 2013/11/21
Last modified on 2013/11/19 11:34:15

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Basic information

Public title

Association between nutritional status/vascular calcification and AGEs/proteolysis pathway in hemodialysis patients

Acronym

Nutrition, vascular calcification, AGEs and proteolysis in hemodialysis patients

Scientific Title

Association between nutritional status/vascular calcification and AGEs/proteolysis pathway in hemodialysis patients

Scientific Title:Acronym

Nutrition, vascular calcification, AGEs and proteolysis in hemodialysis patients

Region

Japan


Condition

Condition

Chronic kidney disease (CKD)

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine factors on nutritional status and vascular calcification in dialysis patients

Basic objectives2

Others

Basic objectives -Others

To evaluate the association between nutoritional/vascular markers and clinical data

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Muscle and fat areas
Vascular calcification score

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

20 years-old <=

Age-upper limit

90 years-old >

Gender

Male and Female

Key inclusion criteria

Patients undergoing maintenance hemodialysis

Key exclusion criteria

more than 20 y.o. and > 90 y.o.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hirotaka Fukasawa

Organization

Iwata City Hospital

Division name

Renal Division

Zip code


Address

512-3 Ohkubo, Iwata, Shizuoka

TEL

0538-38-5000

Email

hfukasawaucsd@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Hirotaka Fukasawa

Organization

Iwata City Hospital

Division name

Renal Division

Zip code


Address

512-3 Ohkubo, Iwata, Shizuoka

TEL

0538-38-5000

Homepage URL


Email

hfukasawaucsd@gmail.com


Sponsor or person

Institute

Iwata City Hospital

Institute

Department

Personal name



Funding Source

Organization

Japanese association of Dialysis Physicians
Japanese Kidney Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

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

2013 Year 11 Month 21 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


Results


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

2011 Year 08 Month 01 Day

Date of IRB


Anticipated trial start date

2011 Year 08 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Cross-sectional study was performed


Management information

Registered date

2013 Year 11 Month 19 Day

Last modified on

2013 Year 11 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014431


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name