UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016190
Receipt number R000018789
Scientific Title Association between plasma pentraxin-3 levels and risk of all-cause mortality in Japanese hemodialysis patients with nutritional risk
Date of disclosure of the study information 2015/02/01
Last modified on 2020/01/20 07:26:43

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Basic information

Public title

Association between plasma pentraxin-3 levels and risk of all-cause mortality in Japanese hemodialysis patients with nutritional risk

Acronym

PTX3 in protein energy wasting

Scientific Title

Association between plasma pentraxin-3 levels and risk of all-cause mortality in Japanese hemodialysis patients with nutritional risk

Scientific Title:Acronym

PTX3 in protein energy wasting

Region

Japan


Condition

Condition

End stage kidney disease

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Persistent inflammation is an important cause of protein-energy wasting, which is a potent predictor of mortality. Therefore, regular monitoring of inflammatory biomarkers may be clinically useful for estimating mortality risk in dialysis patients. Pentraxin-3 (PTX3), a new candidate marker for inflammation, belongs to the same pentraxin superfamily of acute-phase reactants as C-reactive protein (CRP). PTX3 has been reported to be associated with all-cause mortality in Caucasian patients with end-stage kidney disease. However, uncertainty remains regarding PTX3 in relation to nutritional status, and no data are available on PTX3 in Asian hemodialysis patients.

Basic objectives2

Others

Basic objectives -Others

biomarker research

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

All-cause mortality

Key secondary outcomes

Nutritional status
Cardiovascular mortality


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

Maintenance hemodialysis patietnt

Key exclusion criteria

Age < 20 years old
The patient who judged to be inappropriate for the study by attending physician.

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Tetsu
Middle name
Last name TMiyamoto

Organization

University of Occupational and Environmental Health

Division name

Second Department of Internal Medicine

Zip code

807-8555

Address

Iseigaoka 1-1, Yahatanishi, Kitakyushu, Fukuoka

TEL

093-603-1611

Email

tetsum@med.uoeh-u.ac.jp


Public contact

Name of contact person

1st name Tetsu
Middle name
Last name Miyamoto

Organization

University of Occupational and Environmental Health

Division name

Second Department of Internal Medicine

Zip code

807-8555

Address

Second Department of Internal Medicine

TEL

093-603-1611

Homepage URL


Email

tetsum@med.uoeh-u.ac.jp


Sponsor or person

Institute

Second Department of Internal Medicine, University of Occupational and Environmental Health

Institute

Department

Personal name



Funding Source

Organization

Grant-in-Aid for Scientific Research (KAKENHI)

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

University of Occupational and Environmental Health

Address

Iseigaoka 1-1, Yahatanishii, Kitakyushu

Tel

+81936031611

Email

tetsum@med.uoeh-u.ac.jp


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

2015 Year 02 Month 01 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

383

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

No longer recruiting

Date of protocol fixation

2011 Year 08 Month 01 Day

Date of IRB

2011 Year 08 Month 03 Day

Anticipated trial start date

2011 Year 09 Month 01 Day

Last follow-up date

2018 Year 08 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

From Aug of 2011, 380 maintenance hemodialysis patients (38% female; median age, 66 years; age range, 21-92 years) were recruited. We are investigating the effect of plasma PTX3 levels, measured by enzyme-linked immunosorbent assay, on all-cause mortality, with a particular focus on nutritional risk.


Management information

Registered date

2015 Year 01 Month 12 Day

Last modified on

2020 Year 01 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018789


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name