UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049544 |
|---|---|
| Receipt number | R000056390 |
| Scientific Title | Questionnaire survey on the actual situation of dialysis pruritus patients via the Internet |
| Date of disclosure of the study information | 2022/11/24 |
| Last modified on | 2024/09/26 16:12:57 |
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Basic information
Public title
Questionnaire survey on the actual situation of dialysis pruritus patients via the Internet
Acronym
Questionnaire survey on the actual situation of dialysis pruritus patients via the Internet
Scientific Title
Questionnaire survey on the actual situation of dialysis pruritus patients via the Internet
Scientific Title:Acronym
Questionnaire survey on the actual situation of dialysis pruritus patients via the Internet
Region
| Japan |
Condition
Condition
hemodialysis
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We surveyed the actual conditions of patients with pruritus on dialysis by conducting a questionnaire survey via the Internet that does not limit facilities. Contribute to dialysis medical care by publishing the results of this survey.
Basic objectives2
Others
Basic objectives -Others
To provide useful information to hemodialysis patients who suffer from itching and to medical staff who treat them.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire items such as awareness of dialysis pruritus, prevalence, degree and frequency of itching, current treatment status, and treatment satisfaction
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients aged 18 years or older
2)Patients undergoing hemodialysis treatment
Key exclusion criteria
1) Patients undergoing peritoneal dialysis treatment
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Seiichiro |
| Middle name | |
| Last name | Nyui |
Organization
Kissei Pharmaceutical Co., Ltd.
Division name
Medical Department
Zip code
103-0022
Address
Kissei Nihonbashi Building, 1-8-9 Nihonbashi Muromachi, Chuo-ku, Tokyo
TEL
03-3279-2306
ikuyaku@pharm.kissei.co.jp
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Kawasaki |
Organization
QLife.,Co,Ltd.
Division name
Strategic Solution Plannning & Development Dept
Zip code
105-0001
Address
10F Toranomon 33 Mori Building, 3-8-21 Toranomon, Minato-ku, Tokyo
TEL
050-1751-4656
Homepage URL
sst@qlife.co.jp
Sponsor or person
Institute
QLife Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
KISSEI Pharmaceutical co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Takahashi Clinic Ethics Committee
Address
Medicalhat 1F , 5-1-31 ,kitamachi ,iwaya, nada-ku, kobe-shi, Hyogo
Tel
078-882-6432
kishimoto.satoshi@neues.co.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
| 2022 | Year | 11 | Month | 24 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000056390
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jsdt/57/3/57_111/_pdf/-char/ja
Number of participants that the trial has enrolled
485
Results
We enrolled 485 hemodialysis patients who were recruited via the Internet. We found that 378 patients experienced itching, with over 20% of them having encountered moderate or severe itching. A significant proportion of patients with moderate or severe itching experienced impairment in their QOL. Notably, 26.9% of these patients remained untreated. Furthermore, hidden patients with pruritus represented 21.7% of the patient cohort that experienced itching.
Results date posted
| 2024 | Year | 08 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Number of valid responses : 485
Types of dialysis : hemodialysis 485
Age : 18 years and older (Under 65 years old 377, 65 years old and over 108)
Sex : Male 345, Female 132, No answer 8
Participant flow
Consent was obtained from 2,434 respondents, and 485 were valid response cases, excluding the following, other than the patient himself/herself (1,849), age less than 18 years (2), peritoneal dialysis or combined with peritoneal dialysis (41), not receiving dialysis treatment (56), and duplicate respondents (1).
Adverse events
Not collected
Outcome measures
Results of valid responses (N=485)
･Awareness of pruritus : Don't know 118 (24.3%); Know 367 (75.7%)
･Experience of itching : No 107 (22.1%), Yes 378 (77.9%)
Results for those who had experienced itching (N=378)
･The degree of itching at daytime (0-4 points) : moderate (3 points) or higher was 101 patients (26.7%).
･The degree of itching at nighttime (0-4 points) : moderate (3 points) or higher was 78 patients (20.6%).
･67.3-93.6% of patients with moderate or greater itching felt that it had a negative impact on their quality of life.
･Hidden patients with pruritus : 82 (21.7%)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 24 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 28 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 28 | Day |
Date analysis concluded
| 2023 | Year | 11 | Month | 29 | Day |
Other
Other related information
Questionnaire survey to anonymized patient panel
Management information
Registered date
| 2022 | Year | 11 | Month | 17 | Day |
Last modified on
| 2024 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056390
