UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000018789