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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000016190
Receipt No. 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

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

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
URL(English) https://upload.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


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