UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056561 |
|---|---|
| Receipt number | R000064635 |
| Scientific Title | Efficacy of Tenapanor in Managing Hyperphosphatemia and Constipation in Hemodialysis Patients: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2024/12/25 |
| Last modified on | 2025/01/31 17:16:05 |
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Basic information
Public title
Efficacy of Tenapanor in Managing Hyperphosphatemia and Constipation in Hemodialysis Patients: A Randomized Controlled Trial
Acronym
Efficacy of Tenapanor in Managing Hyperphosphatemia and Constipation in Hemodialysis Patients: A Randomized Controlled Trial
Scientific Title
Efficacy of Tenapanor in Managing Hyperphosphatemia and Constipation in Hemodialysis Patients: A Randomized Controlled Trial
Scientific Title:Acronym
Tenapanor for Hyperphosphatemia and Constipation Study
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Medicine in general | Nephrology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We hypothesized that long-term use of tenapanor could normalize the stools of dialysis patients and reduce the amount of laxative used. In this study, we conducted a randamaized control trial to test this hypothesis and to clarify its effect on serum phosphorus levels in actual clinical practice.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in serum phosphorus levels, changes in stool characteristics (Bristol Stool Characteristics Score), and changes in laxative prescription during the observation period.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intervention: Patients who started taking tenaponar. Treatment for 23 weeks. The starting dose was 10 mg/day, and the dose was adjusted by each treating physician according to the serum phosphorus level.
Interventions/Control_2
The type and dosage of medication will be increased or decreased by the treating physician depending on the serum phosphorus level.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Adult patients on maintenance dialysis who received dialysis treatment at the clinic affiliated with Momonikai Hospital between February 1, 2024 and February 31, 2024.
Key exclusion criteria
Exclusion criteria were as follows; (1) patients had to have been undergoing hemodialysis for at least 2 years at baseline, (2) Patients with a history of or current inflammatory bowel disease or diarrhea-type irritable bowel syndrome, and (3) CRP was 1.0 mg/dL or higher.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Suzuki |
Organization
Tojinkai Hospital
Division name
Division of data science
Zip code
6128026
Address
83-1 Iga, Momoyamacho, Fushimi-ku, Kyoto-shi, Kyoto, Japan
TEL
0756221991
suzuki@tojinkai.jp
Public contact
Name of contact person
| 1st name | Naoki |
| Middle name | |
| Last name | Suzuki |
Organization
Tojinkai Hospital
Division name
Data Science Department
Zip code
6128026
Address
83-1 Iga, Momoyamacho, Fushimi-ku, Kyoto-shi, Kyoto, Japan
TEL
0756221991
Homepage URL
suzuki@tojinkai.jp
Sponsor or person
Institute
Tojinkai Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tojinkai Hosupital Ethics Review Committee
Address
83-1 Iga, Momoyamacho, Fushimi-ku, Kyoto-shi, Kyoto, Japan
Tel
0756221991
suzuki@tojinkai.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 | 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
136
Results
TTenapanor improved stool characteristics, resolving constipation (BSFS 1-2) by week 5. Early loose stools (BSFS 6-7) led to 10 discontinuations. Laxative use dropped from 58.2% to 35.6% by week 23. Serum phosphorus control was comparable between groups. Lanthanum carbonate use decreased, replaced by low-dose tenapanor.
Results date posted
| 2024 | Year | 12 | Month | 25 | Day |
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 | 02 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 25 | Day |
Last modified on
| 2025 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064635
