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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038835
Receipt No. R000044289
Scientific Title A prospective observational study in type 2 diabetic patients showing reduced eGFR without albuminuria
Date of disclosure of the study information 2019/12/11
Last modified on 2019/12/10

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Basic information
Public title A prospective observational study in type 2 diabetic patients showing reduced eGFR without albuminuria
Acronym A prospective observational study in type 2 diabetic patients showing reduced eGFR without albuminuria
Scientific Title A prospective observational study in type 2 diabetic patients showing reduced eGFR without albuminuria
Scientific Title:Acronym A prospective observational study in type 2 diabetic patients showing reduced eGFR without albuminuria
Region
Japan

Condition
Condition type 2 diabetes
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To determine the prognosis in Japanese patients with type 2 diabetes showing reduced eGFR without albuminuria.
Basic objectives2 Others
Basic objectives -Others Changes in eGFR, end-stage kidney disease, Incidence of cardiovascular disease, all-cause mortality for 4 years observation are investigated
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Changes in eGFR, end-stage kidney disease, cardiovascular disease, all-cause mortality for 4 years observation
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 patient with type 2 diabetes already evaluated eGFR, uACR and diabetic macroangiopathies
Key exclusion criteria none
Target sample size 600

Research contact person
Name of lead principal investigator
1st name Hiroyuki
Middle name
Last name Ito
Organization Edogawa Hospital
Division name Department of Diabetes, Metabolism and Kidney Disease
Zip code 133-0052
Address 2-24-18, Higashikoiwa, Edogawa-ku, Tokyo, 133-0052, Japan
TEL 03-3673-1229
Email ito@edogawa.or.jp

Public contact
Name of contact person
1st name Hiroyuki
Middle name
Last name Ito
Organization Edogawa Hospital
Division name Department of Diabetes, Metabolism and Kidney Disease
Zip code 133-0052
Address 2-24-18, Higashikoiwa, Edogawa-ku, Tokyo, 133-0052, Japan
TEL 03-3673-1229
Homepage URL
Email ito@edogawa.or.jp

Sponsor
Institute Edogawa Hospital
Department of Diabetes, Metabolism and Kidney Disease
Institute
Department

Funding Source
Organization Edogawa Hospital
Department of Diabetes, Metabolism and Kidney Disease
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 Edogawa Hospital
Address 2-24-18, Higashikoiwa, Edogawa-ku, Tokyo, 133-0052, Japan
Tel 03-3673-1229
Email ito@edogawa.or.jp

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
2019 Year 12 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 675
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
2014 Year 04 Month 01 Day
Date of IRB
2015 Year 07 Month 15 Day
Anticipated trial start date
2014 Year 08 Month 01 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information n/a

Management information
Registered date
2019 Year 12 Month 10 Day
Last modified on
2019 Year 12 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044289

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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