UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028464 |
|---|---|
| Receipt number | 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 | 2024/02/04 10:35:00 |
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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 | Suguru |
| Middle name | |
| Last name | Yamamoto |
Organization
Niigata University Medical and Dental Hospital
Division name
Division of Blood Purification Therapy
Zip code
951-8520
Address
1-754 Asahimachi-dori, Chuo-ku, Niigata 951-8510, Japan
TEL
025-227-2200
yamamots@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Suguru |
| Middle name | |
| Last name | Yamamoto |
Organization
Niigata University Medical and Dental Hospital
Division name
Division of Blood Purification Therapy
Zip code
951-8520
Address
1-754 Asahimachi-dori, Chuo-ku, Niigata 951-8510, Japan
TEL
025-227-2200
Homepage URL
yamamots@med.niigata-u.ac.jp
Sponsor or person
Institute
Division of Blood Purification Therapy, Niigata University Medical and Dental Hospital
Institute
Department
Personal name
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
Niigata UniversityNiigata U
Address
1-757 Asahimachi-dori
Tel
025-227-2005
yamamots@med.niigata-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
| 2017 | Year | 07 | Month | 31 | Day |
Related information
URL releasing protocol
NA
Publication of results
Unpublished
Result
URL related to results and publications
NA
Number of participants that the trial has enrolled
131
Results
The skin itching in hemodialysis patients was frequently observed. The PBUT score, which comprehensively evaluates protein-bound uremic toxins, was significantly associated with the presence or absence of pruritus.
Results date posted
| 2023 | Year | 08 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Chronic hemodialysis patients
Participant flow
Chronic hemodialysis patients participated in the study through the written informed consent.
Adverse events
N/A
Outcome measures
5D-itch scale, serum level of protein-bound uremic toxins.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 31 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 31 | Day |
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
| 2024 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032547
