UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055181 |
|---|---|
| Receipt number | R000063050 |
| Scientific Title | Retrospective clinical study on control of serum phosphorus concentration with tenapanor and calcium carbonate in hemodialysis patients |
| Date of disclosure of the study information | 2024/12/31 |
| Last modified on | 2025/08/15 12:36:44 |
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Basic information
Public title
Study on control of serum phosphorus concentration with phosphorus lowering drugs in dialysis patients
Acronym
Control of serum phosphorus concentration with phosphorus lowering drugs in dialysis patients
Scientific Title
Retrospective clinical study on control of serum phosphorus concentration with tenapanor and calcium carbonate in hemodialysis patients
Scientific Title:Acronym
Retrospective clinical study on control of serum phosphorus concentration with tenapanor and calcium carbonate in hemodialysis patients
Region
| Japan |
Condition
Condition
Patients on hemodialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the control of serum phosphorus concentration for 12 weeks, switching lanthanum carbonate to tenapanor in hemodialysis patients receiving lanthanum carbonate and calcium carbonate.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1 Number of tablets of phosphorus-reducing drugs at the start and after 12 weeks
2 Changes in serum phosphorus concentration and tenapanol dosage over 12 weeks
Key secondary outcomes
1. Number of patients prescribed calcium carbonate, number of patients prescribed active vitamin D analogs, serum corrected calcium concentration, and intact PTH value at the start and 12 weeks after treatment
2. Incidence rate of side effects
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 Maintenance hemodialysis cases and maitenance hemodiafiltration cases as of July 9, 2024
2 Patients who switched from lanthanum carbonate to tenapanor
Key exclusion criteria
1 Patients who underwent dialysis treatment conditions different from those as of July 9, 2024 between April 1, 2024 and July 9, 2024
2 Patients whose dialysis time was less than 3 hours/session and whose dialysis frequency was other than 3 sessions/week
3 Patients who used a blood purification method other than HD or OHDF
4 Patients with serum phosphorus concentration 7.1mg/dL or higher
5 Patients who were prescribed phosphorus-reducing drugs other than lanthanum carbonate and calcium carbonate
6 Patients with medication adherence problems
7 Patients who could not continue due to side effects during the period
8 Patients who received denosumab or romosozumab within 2 months of the start of the study
9 Patients who plan to use denosumab during the study period
10 Patients who received a calcium receptor agonist or bisphosphonates for the first time or had their dose changed within 2 months before the start of the study
11 Patients who received a calcium receptor agonist, romosozumab, denosumab, or bisphosphonates for the first time or had their dose changed during the study period
12 Patients who were hospitalized for more than one week during the study period.
13 Patients who did not take Tenapanor properly through interviews conducted during the study period
14 Patients who experienced loss of appetite
15 Patients with a dry weight decrease or increase of 1 kg or more in the 2 months prior to the start of the study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kazuyoshi |
| Middle name | |
| Last name | Okada |
Organization
Social medical corporation Kawashimakai Kawashima Hospital
Division name
Blood purification management center
Zip code
770-0011
Address
6-1 Kitasako ichiban-cho, Tokushima-shi, Tokushima, Japan
TEL
0886310110
kokada@minos.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Manabu |
| Middle name | |
| Last name | Tashiro |
Organization
Social medical corporation, Kawashimakai, Kawashima hospital
Division name
Department of Nephrology
Zip code
770-0011
Address
6-1 Kitasako ichiban-cho, Tokushima-shi, Tokushima, Japan
TEL
0886310110
Homepage URL
m.tashiro@khg.or.jp
Sponsor or person
Institute
Social medical corporation Kawashimakai
Institute
Department
Personal name
Funding Source
Organization
Social medical corporation Kawashimakai
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
Social medical corporation Kawashimakai, Kawashima Hospital
Address
6-1 Kitasako ichiban-cho, Tokushima-shi, Tokushima, Japan
Tel
0886310110
kokada@minos.ocn.ne.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
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 | 07 | Month | 15 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 08 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Because strict control of serum phosphate (P) concentration using the intestinal Na/H exchanger 3 inhibitor (tenapanor) is expected, this retrospective study is performed in maintenance hemodialysis patients who switched from lanthanum carbonate to tenapanor.
Management information
Registered date
| 2024 | Year | 08 | Month | 07 | Day |
Last modified on
| 2025 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063050
