UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029758 |
|---|---|
| Receipt number | R000033999 |
| Scientific Title | Biomarkers for cardiovascular disease in chronic kidney disease |
| Date of disclosure of the study information | 2017/10/30 |
| Last modified on | 2017/10/30 15:05:49 |
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Basic information
Public title
Biomarkers for cardiovascular disease in chronic kidney disease
Acronym
Biomarkers for cardiovascular disease in chronic kidney disease
Scientific Title
Biomarkers for cardiovascular disease in chronic kidney disease
Scientific Title:Acronym
Biomarkers for cardiovascular disease in chronic kidney disease
Region
| Japan |
Condition
Condition
chronic kidney disease
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigated the relationship between biomarkers for cardiovascular disease and clinical parameters in CKD patients.
Basic objectives2
Others
Basic objectives -Others
None
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
relationship between clinical parameters and biomarkers for cardiovascular disease
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
CKD patients who admitted in our hospital from December 2014 to December 2015
Key exclusion criteria
Patients who reject the participation of this study
Target sample size
1050
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Nishi |
Organization
Kobe university graduate school of medicine
Division name
Division of Nephrology
Zip code
Address
7-5-2 kusunoki cho, chuou ku, Kobe city
TEL
078-382-6500
snishi@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Fujii |
Organization
Kobe university graduate school of medicine
Division name
Division of Nephrology
Zip code
Address
7-5-2 kusunoki cho, chuou ku, Kobe city
TEL
078-382-6500
Homepage URL
http://www.med.kobe-u.ac.jp/kidney/index.html
fhideki@med.kobe-u.ac.jp
Sponsor or person
Institute
Division of nephrology, Kobe university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
Roche diagnostics
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
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
神戸大学病院（兵庫県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 30 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2020 | Year | 01 | Month | 01 | Day |
Date trial data considered complete
| 2020 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 01 | Day |
Other
Other related information
None
Management information
Registered date
| 2017 | Year | 10 | Month | 30 | Day |
Last modified on
| 2017 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033999
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
