UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058363 |
|---|---|
| Receipt number | R000066717 |
| Scientific Title | Burden of Bowel Movement Problems Study in Patients with Hemodialysis |
| Date of disclosure of the study information | 2025/07/31 |
| Last modified on | 2025/07/03 15:55:11 |
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Basic information
Public title
Burden of Bowel Movement Problems Study in Patients with Hemodialysis
Acronym
Burden of Bowel Movement Problems Study in Patients with Hemodialysis
Scientific Title
Burden of Bowel Movement Problems Study in Patients with Hemodialysis
Scientific Title:Acronym
Burden of Bowel Movement Problems Study in Patients with Hemodialysis
Region
| Japan |
Condition
Condition
End-stage kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal patient-reported problems and challenges regarding bowel movement problems in patients with hemodialysis in Japan.
Basic objectives2
Others
Basic objectives -Others
Novel Patient-reported outcomes (PRO) regarding bowel movement problems in patients with hemodialysis in Japan, Patient assessment of constipation quality of life (PAC-QOL)
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Novel Patient-reported outcomes (PRO) regarding bowel movement problems in patients with hemodialysis in Japan, Patient assessment of constipation quality of life (PAC-QOL)
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
A qualitative study
-Patients undergoing outpatient dialysis at Japanese dialysis facilities, aged over 18 years old, and gave informed consent to participation
-Patients feeling about bowel movement problems in their daily living
A quantitative study
-Patients undergoing outpatient dialysis at Japanese dialysis facilities, aged over 18 years old, and gave informed consent to participation
Key exclusion criteria
Patients having structural gastrointestinal diseases
Patients with dementia and psychiatric disorders
Patients using opioids within a month of right before giving informed consent, or at a time of giving informed consent
Patients undergoing chemotherapy within a month of right before giving informed consent, or at a time of giving informed consent
Patients on both hemodialysis and peritoneal dialysis
Patient participating
Patients participating to any clinical trials
Target sample size
212
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Tokunaga |
Organization
Kyowa Kirin Co., Ltd.
Division name
Medical Affairs
Zip code
100-0004
Address
1-9-2, Otemachi, Chiyoda-ku, Tokyo
TEL
03-5205-7200
buenosdias.1g@kyowakirin.com
Public contact
Name of contact person
| 1st name | Shin |
| Middle name | |
| Last name | Tokunaga |
Organization
Kyowa Kirin Co., Ltd.
Division name
Medical Affairs
Zip code
100-0004
Address
1-9-2, Otemachi, Chiyoda-ku, Tokyo
TEL
03-5205-7200
Homepage URL
buenosdias.1g@kyowakirin.com
Sponsor or person
Institute
Kyowa Kirin Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Kyowa Kirin 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
Research Ethical Review Committee of Kyowa Kirin Co., Ltd
Address
1-9-2, Otemachi, Chiyoda-ku, Tokyo
Tel
03-5205-7200
researchethics.fj@kyowakirin.com
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
医療法人社団幸正会岩槻南病院（埼玉県）、医療法人誠仁会なばたけ冬野クリニック（佐賀県）、医療法人社団武蔵野会TMG サテライトクリニック朝霞台（埼玉県）、医療法人友秀会伊丹腎クリニック（北海道）
Other administrative information
Date of disclosure of the study information
| 2025 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 06 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2027 | Year | 01 | Month | 31 | Day |
Other
Other related information
Multicenter, cross-sectional, non-interventional, exploratory sequential mixed methods study using semi-structured interviews and questionnaires
Management information
Registered date
| 2025 | Year | 07 | Month | 03 | Day |
Last modified on
| 2025 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066717
