UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058214 |
|---|---|
| Receipt number | R000066557 |
| Scientific Title | The clinical significance of NT-proBNP measurement in patients undergoing hemodialysis |
| Date of disclosure of the study information | 2025/06/30 |
| Last modified on | 2025/12/19 14:51:29 |
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Basic information
Public title
The clinical significance of NT-proBNP measurement in patients undergoing hemodialysis
Acronym
The clinical significance of NT-proBNP in patients undergoing hemodialysis
Scientific Title
The clinical significance of NT-proBNP measurement in patients undergoing hemodialysis
Scientific Title:Acronym
NT-proBNP in hemodialysis patients
Region
| Japan |
Condition
Condition
Hemodialysis patents
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the clinical significance of NT-proBNP in determining dry weight and assessing myocardial status in patients undergoing hemodialysis.
Basic objectives2
Others
Basic objectives -Others
To investigate the relationship between NT-proBNP and BNP following sacubitril/valsartan administration.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The relationship between various echocardiographic parameters and NT-proBNP levels
Key secondary outcomes
Evaluation of NT-proBNP levels following sacubitril/valsartan administration
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
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients undergoing maintenance hemodialysis two to three times per week.
Key exclusion criteria
None
Target sample size
168
Research contact person
Name of lead principal investigator
| 1st name | Ryoichi |
| Middle name | |
| Last name | Miyazaki |
Organization
Fujita Memorial Hospital
Division name
Iternal Medicine
Zip code
910-0004
Address
4-15-7, Houei, Fukui, 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
Iternal 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
Ryichi 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
4-15-7, Houei, Fukui City
Tel
+81-0776-21-1277
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
SELECT
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
168
Results
Post-dialysis NT-proBNP and BNP levels showed a strong positive correlation regardless of the administration of sacubitril/valsartan. NT-proBNP levels were also correlated with left ventricular mass index as assessed by echocardiography.
Results date posted
| 2025 | Year | 06 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 11 | Month | 01 | Day |
Baseline Characteristics
Patients undergoing maintenance hemodialysis two to three times per week at Fujita Memorial Hospital.
Participant flow
The observation period is scheduled from March to July 2025.
Adverse events
None
Outcome measures
The relationship between post-dialysis NT-proBNP and BNP levels, as well as the relationship between NT-proBNP and various echocardiographic parameters.
Plan to share IPD
None
IPD sharing Plan description
None
Progress
Recruitment status
Completed
Date of protocol fixation
| 2025 | Year | 03 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2025 | Year | 03 | Month | 03 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2026 | Year | 04 | Month | 15 | Day |
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 06 | Month | 18 | Day |
Last modified on
| 2025 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066557
