UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058262 |
|---|---|
| Receipt number | R000066600 |
| Scientific Title | The specified drug use study of tenapanor tablets,"study on the long-term use in hemodialysis patients" |
| Date of disclosure of the study information | 2025/06/25 |
| Last modified on | 2025/06/24 11:02:49 |
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Basic information
Public title
The specified drug use study of tenapanor tablets,"study on the long-term use in hemodialysis patients"
Acronym
The specified drug use study of tenapanor tablets
Scientific Title
The specified drug use study of tenapanor tablets,"study on the long-term use in hemodialysis patients"
Scientific Title:Acronym
The specified drug use study of tenapanor tablets
Region
| Japan |
Condition
Condition
Hypophosphatemia during hemodialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the safety and efficacy of long-term use of tenapanor tablets under real-world conditions in patients with hyperphosphatemia undergoing hemodialysis
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Safety
(1) Incidence of adverse events
(2) Incidence of adverse drug reactions, including infections
(3) Considerations for safety specification
(4) Examination of factors that may influence safety
2. Efficacy
(1) Trends in serum phosphate (P) levels during the observation period
(2) Efficacy rate based on the achievement of guideline-recommended serum P levels at the end of the observation period and throughout the observation period
(3) Efficacy rates stratified by patient background
(4) Examination of factors that may influence the assessment of efficacy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing hemodialysis who are initiating the use of this drug for the improvement of hyperphosphatemia in chronic kidney disease
Key exclusion criteria
Patients who are receiving peritoneal dialysis concurrently at the time of case registration
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kuwazawa |
Organization
Kyowa Kirin Co.,Ltd.
Division name
Pharmacovigilance division
Zip code
100-0004
Address
1-9-2 Ohtemachi, Chiyoda-ku, Tokyo
TEL
03-5205-7200
hiroshi.kuwazawa.wd@kyowakirin.com
Public contact
Name of contact person
| 1st name | Chiemi |
| Middle name | |
| Last name | Nishida |
Organization
Kyowa Kirin Co.,Ltd.
Division name
Pharmacovigilance division
Zip code
100-0004
Address
1-9-2 Ohtemachi, Chiyoda-ku, Tokyo
TEL
03-5205-7200
Homepage URL
chiemi.nishida.f4@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
Japan
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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 25 | 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
1083
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 10 | Month | 06 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 02 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2025 | Year | 06 | Month | 24 | Day |
Last modified on
| 2025 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066600
