UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007656
Receipt No. R000008898
Scientific Title Hiroshima NT-proBNP study in hemodialysis patients (HINT)
Date of disclosure of the study information 2012/04/03
Last modified on 2012/08/23

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email sdoi@hiroshima-u.ac.jp

Sponsor
Institute Department of Nephrology, Hiroshima University Hospital
Institute
Department

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
Email

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 Open public recruiting
Date of protocol fixation
2011 Year 09 Month 06 Day
Date of IRB
Anticipated trial start date
2012 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information death and cardia-vasuclar events

Management information
Registered date
2012 Year 04 Month 03 Day
Last modified on
2012 Year 08 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008898

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.