UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022681 |
|---|---|
| Receipt number | R000026141 |
| Scientific Title | Clinical characteristics of diabetic kidney disease |
| Date of disclosure of the study information | 2016/07/11 |
| Last modified on | 2016/06/09 15:00:05 |
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Basic information
Public title
Clinical characteristics of diabetic kidney disease
Acronym
Clinical characteristics of diabetic kidney disease
Scientific Title
Clinical characteristics of diabetic kidney disease
Scientific Title:Acronym
Clinical characteristics of diabetic kidney disease
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the clinical characteristics of diabetic kidney disease without overt proteinuria.
Basic objectives2
Others
Basic objectives -Others
nothing special
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
kidney function, blood pressure, the degree of atherosclerosis, findings of echocardiography, past history of ischemic heart disease
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients(eGFR<60) who took CKD education in Kobe university hospital and Akashi medical center.
Key exclusion criteria
nothing
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nishi Shinichi |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Nephrology
Zip code
Address
7-5-2, Kusunoki cho, Chuo 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 | Kono Keiji |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Nephrology
Zip code
Address
7-5-2, Kusunoki cho, Chuo ku, Kobe City
TEL
078-382-6500
Homepage URL
kkono@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University Graduate School of Medicine, Division of Nephrology
Institute
Department
Personal name
Funding Source
Organization
Kobe University Graduate School of Medicine, Division of Nephrology
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Akashi Medical Center
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、明石医療センター
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 11 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 06 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 09 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2016 | Year | 06 | Month | 09 | Day |
Last modified on
| 2016 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026141
