UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003614 |
|---|---|
| Receipt number | R000004381 |
| Scientific Title | A clinical study of endothelial function and cardiac function and cardio-renal biomarkers in chronic kidney disease |
| Date of disclosure of the study information | 2010/05/14 |
| Last modified on | 2015/06/13 17:10:20 |
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Basic information
Public title
A clinical study of endothelial function and cardiac function and cardio-renal biomarkers in chronic kidney disease
Acronym
cardio-renal association study
Scientific Title
A clinical study of endothelial function and cardiac function and cardio-renal biomarkers in chronic kidney disease
Scientific Title:Acronym
cardio-renal association study
Region
| Japan |
Condition
Condition
chronic kidney disease
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To research the endothelial function and cardiac diastolic function and the biomarkers associated with them in chronic kidney disease
Basic objectives2
Others
Basic objectives -Others
epidemiological study
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
researching endothelial function and cardiac diastolic function and cardio-renal biomarkers, conducting statistical analysis
Key secondary outcomes
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
chronic kidney disease
Key exclusion criteria
vasculitis, collagen disease, malignancy, dialysis, ischemic heart disease, atrial fibrillation and valvular disease and so on
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirofumi Makino |
Organization
Okayama university Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan
Division name
Department of Medicine and Clinical Science
Zip code
Address
2-5-1 Shikata-Cho, Kita-Ward, Okayama, Okayama 700-8558, Japan
TEL
086-235-7235
makino@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahi Kitagawa |
Organization
Okayama university Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama
Division name
Department of Medicine and Clinical Science
Zip code
Address
2-5-1 Shikata-Cho, Kita-Ward, Okayama, Okayama 700-8558, Japan
TEL
086-235-7235
Homepage URL
masa4_n_r@yahoo.co.jp
Sponsor or person
Institute
Okayama university Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
Okayama university Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 05 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2009 | Year | 04 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
observational study
Management information
Registered date
| 2010 | Year | 05 | Month | 14 | Day |
Last modified on
| 2015 | Year | 06 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004381
