UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057310 |
|---|---|
| Receipt number | R000065510 |
| Scientific Title | Evaluation of tenapanor administration in hemodialysis patients on laxative therapy |
| Date of disclosure of the study information | 2025/06/30 |
| Last modified on | 2025/03/17 15:01:36 |
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Basic information
Public title
Evaluation of tenapanor administration in hemodialysis patients on laxative therapy
Acronym
Evaluation of tenapanor administration in hemodialysis patients
Scientific Title
Evaluation of tenapanor administration in hemodialysis patients on laxative therapy
Scientific Title:Acronym
Evaluation of tenapanor administration in hemodialysis patients
Region
| Japan |
Condition
Condition
Hemodialysis patient taking laxatives for constipation
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Reduction or discontinuation of laxatives for hemodialysis patients
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Reduction or discontinuation of laxatives for hemodialysis patients
Key secondary outcomes
Discontinuation of stimulant laxatives in hemodialysis patients
Compliance rate with new guidelines for serum phosphorus
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Hemodialysis patients on regular laxative therapy
Key exclusion criteria
Patients who have previously taken tenapanor
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | RYOICHI |
| Middle name | |
| Last name | MIYAZAKI |
Organization
Fujita Memorial Hospital
Division name
Internal Medicine
Zip code
910-0004
Address
4-15-7, Houei, Fukui City
TEL
+81-776-21-1277
ryoichi@mitene.or.jp
Public contact
Name of contact person
| 1st name | RYOICHI |
| Middle name | |
| Last name | MIYAZAKI |
Organization
Fujita Memorial Hospital
Division name
Internal Medicine
Zip code
910-0004
Address
4-15-7, Houei, Fukui City
TEL
+81-776-21-1277
Homepage URL
http://www.fujita-mhp.jp/
ryoichi@mitene.or.jp
Sponsor or person
Institute
Fujita Memorial Hospital
Institute
Department
Personal name
RYOICHI MIYAZAKI
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujita Memorial Hospital
Address
4-16-11, Houei, Fukui City
Tel
+81-776-21-1277
ryoichi@mitene.or.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
| 2025 | Year | 06 | Month | 30 | Day |
Related information
URL releasing protocol
https://rrtjournal.biomedcentral.com
Publication of results
Unpublished
Result
URL related to results and publications
https://rrtjournal.biomedcentral.com
Number of participants that the trial has enrolled
15
Results
Laxatives could be reduced or discontinued.
Results date posted
| 2025 | Year | 03 | Month | 17 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Since only four months have passed since the study began.
Date of the first journal publication of results
| 2026 | Year | 04 | Month | 01 | Day |
Baseline Characteristics
Hemodialysis patients taking laxatives
Participant flow
Scheduled to follow-up up to 6 months after starting Tenapanol administration
Adverse events
Adverse events, including clinical symptoms such as diarrhea and abnormal test values
Outcome measures
Amount of laxative, amount of phosphorus adsorbent, serum phosphorus level
Plan to share IPD
None
IPD sharing Plan description
None
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2024 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 11 | Day |
Last follow-up date
| 2025 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 07 | Month | 01 | Day |
Date trial data considered complete
| 2025 | Year | 07 | Month | 01 | Day |
Date analysis concluded
| 2025 | Year | 07 | Month | 15 | Day |
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 03 | Month | 17 | Day |
Last modified on
| 2025 | Year | 03 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065510
