UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061311 |
|---|---|
| Receipt number | R000070155 |
| Scientific Title | Rethinking B-type natriuretic peptide and N-terminal pro-B-type natriuretic peptide in hemodialysis patients |
| Date of disclosure of the study information | 2026/04/19 |
| Last modified on | 2026/04/19 22:28:40 |
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Basic information
Public title
Rethinking B-type natriuretic peptide and N-terminal pro-B-type natriuretic peptide in hemodialysis patients
Acronym
Rethinking of natriuretic peptides in h0emodialysis patients
Scientific Title
Rethinking B-type natriuretic peptide and N-terminal pro-B-type natriuretic peptide in hemodialysis patients
Scientific Title:Acronym
Rethinking of natriuretic peptides in h0emodialysis patients
Region
| Japan |
Condition
Condition
168 patients undergoing maintenance hemodialysis, 75 had not received sacubitril/valsartan, while 93 had been receiving the same medication for at least 3 months.
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Correlation between BNP and NT-proBNP according to the presence or absence of sacubitril/valsartan therapy, and changes in BNP and NT-proBNP before and after hemodialysis.
Basic objectives2
Others
Basic objectives -Others
None.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
1.To examine whether a positive correlation between BNP and NT-proBNP is observed according to the presence or absence of sacubitril/valsartan therapy, and whether a similar correlation is maintained irrespective of its administration. 2.To determine, based on changes in BNP and NT-proBNP before and after hemodialysis, whether measurements in hemodialysis patients should be interpreted using pre-dialysis or post-dialysis values.
Key secondary outcomes
None.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
A patient undergoing maintenance hemodialysis three times a week at Fujita Memorial Hospital.
Key exclusion criteria
Patients who have been taking sacubitril/valsartan for less than 3 months.
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
0776211277
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
0776211277
Homepage URL
http://www.fujita-mhp.jp/
ryoichi@mitene.or.jp
Sponsor or person
Institute
Fujita Memorial Hospital
Institute
Department
Personal name
RYOICHI MIYAZAKI
Funding Source
Organization
Fujita Memorial Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
None.
Name of secondary funder(s)
None.
IRB Contact (For public release)
Organization
Fujita Memorial Hospital
Address
4-15-7, Houei, Fukui City
Tel
0776211277
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
藤田記念病院
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
https://link.springer.com/journal/41100/articles
Number of participants that the trial has enrolled
168
Results
1. Regardless of whether sacubitril/valsartan was administered, BNP and NT-proBNP showed a positive correlation, and there was no significant difference in the correlation coefficient.
2. Both BNP and NT-proBNP levels decreased significantly during dialysis; however, there was no correlation between the degree of decrease in either BNP or NT-proBNP and the amount of weight loss during dialysis.
Results date posted
| 2026 | Year | 04 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2026 | Year | 10 | Month | 30 | Day |
Baseline Characteristics
Patients undergoing hemodialysis three times a week at Fujita Memorial Hospital
Participant flow
Adverse events
None.
Outcome measures
The correlation between BNP and NT-proBNP after dialysis, and the relationship between Log(NT-proBNP) and various echocardiographic parameters
Plan to share IPD
No plans to share.
IPD sharing Plan description
No plans to share.
Progress
Recruitment status
Completed
Date of protocol fixation
| 2025 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 10 | Day |
Date of closure to data entry
| 2026 | Year | 04 | Month | 09 | Day |
Date trial data considered complete
| 2026 | Year | 04 | Month | 10 | Day |
Date analysis concluded
| 2026 | Year | 04 | Month | 15 | Day |
Other
Other related information
None.
Management information
Registered date
| 2026 | Year | 04 | Month | 19 | Day |
Last modified on
| 2026 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070155
