UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022124 |
|---|---|
| Receipt number | R000025505 |
| Scientific Title | The observational study of diabetic nephropathy with microalbuminuria in the Tsugaru resion |
| Date of disclosure of the study information | 2016/04/28 |
| Last modified on | 2016/04/28 18:22:01 |
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Basic information
Public title
The observational study of diabetic nephropathy with microalbuminuria in the Tsugaru resion
Acronym
The observational study of diabetic nephropathy with microalbuminuria in the Tsugaru resion (TSUGARU Study)
Scientific Title
The observational study of diabetic nephropathy with microalbuminuria in the Tsugaru resion
Scientific Title:Acronym
The observational study of diabetic nephropathy with microalbuminuria in the Tsugaru resion (TSUGARU Study)
Region
| Japan |
Condition
Condition
The patients of diabetic nephropathy with microalbuminuria
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the rate of remission and progression from microalbuminuria in patients with type 2 diabetes, and the factors associated with remission and progression of diabetic nephropathy
Basic objectives2
Others
Basic objectives -Others
To clarify the rate of remission and progression from microalbuminuria in patients with type 2 diabetes, and the factors associated with remission and progression of diabetic nephropathy
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The rate of remission (norm albuminuria), and the rate of progression (overt proteinuria) at 36 months after the registration
Key secondary outcomes
The investigation of the factors contributed to remission and progression at 36 months after the registration
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
The patients of diabetic nephropathy with microalbuminuria(30~300 mg/gCr)
Key exclusion criteria
The patients of diabetic nephropathy with albuminuria(less than 30 mg/gCr or over 300 mg/gCr)
Target sample size
317
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norio Nakamura |
Organization
Hirosaki University Graduate School of Medicine
Division name
Community Medicine
Zip code
Address
Zaifu-cho 5, Hirosaki-city
TEL
0172-39-5057
nnakamur@r2.dion.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norio Nakamura |
Organization
Hirosaki University Graduate School of Medicine
Division name
Community Medicine
Zip code
Address
Zaifu-cho 5, Hirosaki-city
TEL
0172-39-5057
Homepage URL
nnakamur@r2.dion.ne.jp
Sponsor or person
Institute
Community Medicine, Hirosaki University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
弘前大学医学部附属病院/ Hirosaki University Hospital
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 28 | 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
The rate of remission from microalbuminuria was 27.4 %, and the rate of progression from microalbuminuria was 13.7 % at 36 months after the registration.
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 | 03 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 28 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 08 | Month | 10 | Day |
Date analysis concluded
Other
Other related information
The rate of remission from microalbuminuria was 27.4 %, and the rate of progression from microalbuminuria was 13.7 % at 36 months after the registration.
Management information
Registered date
| 2016 | Year | 04 | Month | 28 | Day |
Last modified on
| 2016 | Year | 04 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025505
| 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 |
