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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028464
Receipt No. R000032547
Scientific Title Association of serum protein-bound uremic toxin levels with uremic pruritus and quality of life in hemodialysis patients
Date of disclosure of the study information 2017/07/31
Last modified on 2017/07/31

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Basic information
Public title Association of serum protein-bound uremic toxin levels with uremic pruritus and quality of life in hemodialysis patients
Acronym PBUTs and pruritus/QOL in HD patients
Scientific Title Association of serum protein-bound uremic toxin levels with uremic pruritus and quality of life in hemodialysis patients
Scientific Title:Acronym PBUTs and pruritus/QOL in HD patients
Region
Japan

Condition
Condition Chronic kidney disease undergoing hemodialysis treatment
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine association of serum protein-bound uremic toxin levels with pruritus.
Basic objectives2 Others
Basic objectives -Others To examine association of serum protein-bound uremic toxin levels with quality of life.
To examine the association between pruritus and clinical outcomes including mortality, cardiovascular event and infection
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Association of protein-bound uremic toxins, such as indoxyl sulfate, p-cresyl sulfate and phenyl sulfate, with degree of pruritus from visual analog scale and 5D itch scale.
Key secondary outcomes Association of protein-bound uremic toxins, such as indoxyl sulfate, p-cresyl sulfate and phenyl sulfate, with quality of life score using KDQOL.

All cause mortality, hospitalization owing
to cardiovascular event and infection during two year observation.

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
100 years-old >=
Gender Male and Female
Key inclusion criteria 1. Chronic kidney disease patients undergoing hemodilysis treatment
2. Participants provided written informed consent
Key exclusion criteria 1. Participants who do not recieve hemodialysis treatment.
Target sample size 133

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Suguru Yamamoto
Organization Niigata University Medical and Dental Hospital
Division name Division of Blood Purification Therapy
Zip code
Address 1-754 Asahimachi-dori, Chuo-ku, Niigata 951-8510, Japan
TEL 025-227-2200
Email yamamots@med.niigata-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Suguru Yamamoto
Organization Niigata University Medical and Dental Hospital
Division name Division of Blood Purification Therapy
Zip code
Address 1-754 Asahimachi-dori, Chuo-ku, Niigata 951-8510, Japan
TEL 025-227-2200
Homepage URL
Email yamamots@med.niigata-u.ac.jp

Sponsor
Institute Division of Blood Purification Therapy, Niigata University Medical and Dental Hospital
Institute
Department

Funding Source
Organization Division of Blood Purification Therapy, Niigata University Medical and Dental Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Kureha Corporation
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 31 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 Open public recruiting
Date of protocol fixation
2017 Year 07 Month 31 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We will examine associations of uremic pruritus and QOL in hemodialysis patients with blood level of uremic toxins with a cross sectional study.
Skin itching will be assessed by visual analog scale and 5-D itch scale, and QOL will be assessed by KDQOL. Blood uremic toxins, such as indoxyl sulfate, p-cresyl sulfate and phenyl sulfate, will be measured by mass spectrometry.

Management information
Registered date
2017 Year 07 Month 31 Day
Last modified on
2017 Year 07 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032547

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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