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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039129
Receipt No. R000044625
Scientific Title Study on renal function decline in type 2 diabetes with CKD stage 3
Date of disclosure of the study information 2020/01/11
Last modified on 2020/01/11

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Basic information
Public title Study on renal function decline in type 2 diabetes with CKD stage 3
Acronym Study on renal function decline in type 2 diabetes with CKD stage 3
Scientific Title Study on renal function decline in type 2 diabetes with CKD stage 3
Scientific Title:Acronym Study on renal function decline in type 2 diabetes with CKD stage 3
Region
Japan

Condition
Condition Type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine whether appropriate treatment under daily outpatient care supress renal function decline in type 2 diabetes with CKD stage 3.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes eGFR changes
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 Type 2 diabetic patients with CKD stage 3 visiting our department during January to March in 2017
Key exclusion criteria Patients who are judged to be inappropriate as subject by the investigator
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Sou
Middle name
Last name Nagai
Organization NTT-East Sapporo Hospital
Division name Department of diabetes and endocrinology
Zip code 0600061
Address Nishi 15, Minami 1, Chuuou-ku, Sapporo, Hokkaido, JAPAN
TEL 011-623-7000
Email smc.webmaster-ml@east.ntt.co.jp

Public contact
Name of contact person
1st name Sou
Middle name
Last name Nagai
Organization NTT-East Sapporo Hospital
Division name Department of diabetes and endocrinology
Zip code 0600061
Address Nishi 15, Minami 1, Chuuou-ku, Sapporo, Hokkaido, JAPAN
TEL 011-623-7000
Homepage URL
Email smc.webmaster-ml@east.ntt.co.jp

Sponsor
Institute NTT-East Sapporo Hospital
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 NTT-East Sapporo Hospital
Address Nishi 15, Minami 1, Chuuou-ku, Sapporo, Hokkaido, JAPAN
Tel 011-623-7000
Email smc.webmaster-ml@east.ntt.co.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
2020 Year 01 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 Enrolling by invitation
Date of protocol fixation
2019 Year 09 Month 11 Day
Date of IRB
2019 Year 10 Month 03 Day
Anticipated trial start date
2020 Year 01 Month 14 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Ovserve eGFR to 2021

Management information
Registered date
2020 Year 01 Month 11 Day
Last modified on
2020 Year 01 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044625

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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