UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061023 |
|---|---|
| Receipt number | R000069077 |
| Scientific Title | The effcts of antacid administration on phosphate binders in patients undergoing dialysis. |
| Date of disclosure of the study information | 2026/03/24 |
| Last modified on | 2026/03/23 17:01:57 |
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Basic information
Public title
The effcts of antacid administration on phosphate binders in patients undergoing dialysis.
Acronym
The effcts of antacid administration on phosphate binders in patients undergoing dialysis.
Scientific Title
The effcts of antacid administration on phosphate binders in patients undergoing dialysis.
Scientific Title:Acronym
The effcts of antacid administration on phosphate binders in patients undergoing dialysis.
Region
| Japan |
Condition
Condition
hronic renal failure undergoing dialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, using the MBD-NEXT database, a high-granularity real-world data set of Japanese hemodialysis patients, we aim to elucidate the impact of proton pump inhibitor use on the prescription volume of phosphate binders in maintenance hemodialysis patients.
Basic objectives2
Others
Basic objectives -Others
Retrospective observational study based on existing data
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Daily phosphorus adsorbent usage
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
Hemodialysis patients attending a dialysis facility as outpatients who agree to participate in the study
Key exclusion criteria
Patients on peritoneal dialysis
Target sample size
8800
Research contact person
Name of lead principal investigator
| 1st name | Sayaka |
| Middle name | |
| Last name | Shimizu |
Organization
Institute for Health Outcomes & Process Evaluation Research
Division name
Research Division
Zip code
604-8006
Address
Shimomaruya-cho 403 Nakagyo-ku Kyoto-city Japan
TEL
075-555-3457
Shimizu@i-hope.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Kabaya |
Organization
Patient Driven Academic League
Division name
Administrative Division
Zip code
6040924
Address
537-20 Ichinofunairi-cho Nakagyo-ku Kyoto-city Japan
TEL
075-777-1261
Homepage URL
admin@pedal.or.jp
Sponsor or person
Institute
Patient Driven Academic League
Institute
Department
Personal name
Funding Source
Organization
Kyowa Kirin Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institute for Health Outcomes & Process Evaluation Research
Address
Shimomaruya-cho 403 Nakagyo-ku Kyoto-city Japan
Tel
075-555-3457
kabaya@i-hope.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
| 2026 | Year | 03 | Month | 24 | Day |
Related information
URL releasing protocol
recruite finished
Publication of results
Unpublished
Result
URL related to results and publications
recruite finished
Number of participants that the trial has enrolled
8800
Results
recruite finished
Results date posted
| 2026 | Year | 03 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
dialysis patients
Participant flow
recruite finished
Adverse events
No observation
Outcome measures
recruite finished
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2018 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data from observational studies were used; data were collected retrospectively from 2017 until the date consent was obtained. Prospective data collection after the date consent was obtained.
Management information
Registered date
| 2026 | Year | 03 | Month | 23 | Day |
Last modified on
| 2026 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069077
