UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056601 |
|---|---|
| Receipt number | R000064686 |
| Scientific Title | Investigation of water intake requirements for medication in patients undergoing hemodialysis |
| Date of disclosure of the study information | 2024/12/31 |
| Last modified on | 2025/12/30 16:35:59 |
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Basic information
Public title
Investigation of water intake requirements for medication in patients undergoing hemodialysis
Acronym
Water intake requirements for medication in patients undergoing hemodialysis
Scientific Title
Investigation of water intake requirements for medication in patients undergoing hemodialysis
Scientific Title:Acronym
Water intake requirements for medication in patients undergoing hemodialysis
Region
| Japan |
Condition
Condition
End stage kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the current status of the amount of water dialysis patients need to drink to take their medication and the impact of prescription changes on this amount of water.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in water intake requirements for medication following prescription changes.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients undergoing hemodialysis at Kageyama Urology Clinic and medication management at Yamanouchi Pharmacy.
2. Japanese males and females aged over 20 years old at the time of informed consent.
3. Patients who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study.
Key exclusion criteria
1. Patients who are deemed inappropriate by the principal investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Katsuya |
| Middle name | |
| Last name | Yamauchi |
Organization
Yamauchi pharmacy
Division name
Yamauchi pharmacy
Zip code
420-0838
Address
8-7 Aioi-cho, Aoi-ku, Shizuoka
TEL
054-200-0255
rinbokukan@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Suzuki |
Organization
Yamauchi pharmacy
Division name
Yamauchi pharmacy
Zip code
420-0838
Address
8-7 Aioi-cho, Aoi-ku, Shizuoka
TEL
054-200-0255
Homepage URL
rinbokukan@yahoo.co.jp
Sponsor or person
Institute
Yamauchi Pharmacy
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of the Tokokai Medical Corporation Association
Address
9-5 Aioi-cho, Aoi-ku, Shizuoka
Tel
054-247-2785
aioicho@fmwbs.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
| 2024 | Year | 12 | 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
6
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
Completed
Date of protocol fixation
| 2024 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
All hemodialysis patients who used Yamanouchi Pharmacy during the survey period will be contacted and recruited.
Management information
Registered date
| 2024 | Year | 12 | Month | 29 | Day |
Last modified on
| 2025 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064686
