UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007656 |
|---|---|
| Receipt number | R000008898 |
| Scientific Title | Hiroshima NT-proBNP study in hemodialysis patients (HINT) |
| Date of disclosure of the study information | 2012/04/03 |
| Last modified on | 2023/02/03 18:53:13 |
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Basic information
Public title
Hiroshima NT-proBNP study in hemodialysis patients (HINT)
Acronym
NT-proBNP in hemodialysis patients
Scientific Title
Hiroshima NT-proBNP study in hemodialysis patients (HINT)
Scientific Title:Acronym
NT-proBNP in hemodialysis patients
Region
| Japan |
Condition
Condition
end stage renal failure
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify NT-proBNP as a predictor of cardiovascular events and all cause death in hemodialysis patient
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
death
Key secondary outcomes
Cardiovascular event
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
Patients who undergo hemodialysis three times a week
Key exclusion criteria
Patients who are younger than 20 years old, peritoneal dialysis patients, do not undergo hemodialysis three times a week, have a poor prognosis cancer, have a severe infectious disease, and show symptoms of heart failure at rest
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | MASAKI, Takao |
Organization
Hiroshima University Hospital
Division name
Department of Nephrology
Zip code
Address
1-2-3 Kasumi Minami-ku, Hiroshima,
TEL
082-257-1506
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | DOI, Shigehiro |
Organization
Hiroshima University Hospital
Division name
Department of Blood Purification
Zip code
Address
1-2-3 Kasumi Minami-ku, Hiroshima,
TEL
082-257-5960
Homepage URL
sdoi@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of Nephrology, Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Roche Diagnostics KK
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
広島大学病院(広島県)、尾道クリニック(広島県)、尾道総合病院（広島県）、中央内科クリニック(広島県)、呉共済病院(広島県)、呉医療センター(広島県)、博愛クリニック（広島県）、広島ベイクリニック（広島県）、小田内科クリニック（広島県）、県立広島病院（広島県）、イーストクリニック（広島県）、横川クリニック（広島県）、井口医院（広島県）、一陽会原田病院(広島県)、広島総合病院(広島県)、あかね会土谷総合病院(広島県)、中島土谷クリニック(広島県)、大町土谷クリニック(広島県)
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 03 | 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
| 2011 | Year | 09 | Month | 06 | Day |
Date of IRB
| 2011 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 03 | Day |
Date of closure to data entry
| 2023 | Year | 02 | Month | 03 | Day |
Date trial data considered complete
| 2023 | Year | 02 | Month | 03 | Day |
Date analysis concluded
| 2023 | Year | 02 | Month | 03 | Day |
Other
Other related information
death and cardia-vasuclar events
Management information
Registered date
| 2012 | Year | 04 | Month | 03 | Day |
Last modified on
| 2023 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008898
