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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000023599
Receipt No. R000027139
Scientific Title Prognosis, complications, and treatments of diabetic nephropathy: Prospective observational study
Date of disclosure of the study information 2016/09/01
Last modified on 2019/02/14

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Basic information
Public title Prognosis, complications, and treatments of diabetic nephropathy: Prospective observational study
Acronym Prognosis, complications, and treatments of diabetic nephropathy: Prospective observational study
Scientific Title Prognosis, complications, and treatments of diabetic nephropathy: Prospective observational study
Scientific Title:Acronym Prognosis, complications, and treatments of diabetic nephropathy: Prospective observational study
Region
Japan

Condition
Condition Diabetic nephropathy
Classification by specialty
Endocrinology and Metabolism Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To revise diagnostic criteria, stage classification, and treatment guidelines of diabetic nephropathy based on laboratory results and therapeutic regimen
Basic objectives2 Others
Basic objectives -Others we make long-term, trailable prospective cohort to establish the situation of diabetic nephropathy
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1. Evaluation of serial renal dysfunction by proteinuria, albuminuria, and GFR
Cardiovascular event
2. The number of death according to stage classification
3. Cardiovascular event and onset of diabetic complications other than nephropathy
Key secondary outcomes 1. Risk factor analysis for the progression of renal dysfuction
2. therapeutic goalachievement

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 Type 2 diabetes
Key exclusion criteria 1. Type 1 diabetes
2. Secondary diabetes
3. Concomitant renal disease other than diabetic nephropathy
Target sample size 25

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Tomohito Gohda
Organization Juntendo University Faculty of medicine
Division name Division of Nephrology
Zip code
Address 15-5-29 Yushima, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Email goda@juntendo.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Tomohito Gohda
Organization Juntendo University Faculty of medicine
Division name Division of Nephrology
Zip code
Address 15-5-29 Yushima, Bunkyo-ku, Tokyo
TEL 03-3813-3111
Homepage URL
Email goda@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 01 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
2016 Year 07 Month 29 Day
Date of IRB
Anticipated trial start date
2016 Year 07 Month 29 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 1. Evaluation of serial renal dysfunction by proteinuria, albuminuria, and GFR
Cardiovascular event
2. The number of death according to stage classification
3. Cardiovascular event and onset of diabetic complications other than nephropathy

Management information
Registered date
2016 Year 08 Month 12 Day
Last modified on
2019 Year 02 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027139

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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