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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031821
Receipt No. R000036338
Scientific Title Study on proper use of the incretin related drugs and effects on renal function.
Date of disclosure of the study information 2018/03/20
Last modified on 2019/09/20

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Basic information
Public title Study on proper use of the incretin related drugs and effects on renal function.
Acronym Super REAL
Scientific Title Study on proper use of the incretin related drugs and effects on renal function.
Scientific Title:Acronym Super REAL
Region
Japan

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

Objectives
Narrative objectives1 We clarify whether the use of incretin related drugs for diabetic patients is properly used based on renal function. In addition, we study the effects on clinical parameters, especially kidney function.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes eGFR change
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 diabetes patients who used incretin related drugs in our hospital from 1st December 2009 to 31st May 2017.
Key exclusion criteria Cases in which the test results were lost due to the transfer.
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name Masao
Middle name
Last name Toyoda
Organization Tokai University School of Medicine
Division name Division of Nephrology, Endocrinology and Metabolism
Zip code 259-1193
Address 143 Shimokasuya, Isehara, Kanagawa 2 59-1193, JAPAN
TEL 0463-93-1121
Email m-toyoda@is.icc.u-tokai.ac.jp

Public contact
Name of contact person
1st name Kanori
Middle name
Last name Iwamatsu
Organization Tokai University School of Medicine
Division name Division of Nephrology, Endocrinology and Metabolism
Zip code 259-1193
Address 143 Shimokasuya, Isehara, Kanagawa 2 59-1193, JAPAN
TEL 0463-93-1121
Homepage URL
Email k-iwamtsu@tsc.u-tokai.ac.jp

Sponsor
Institute Division of Nephrology, Endocrinology and Metabolism, Tokai University Scho ol of Medicine
Institute
Department

Funding Source
Organization Division of Nephrology, Endocrinology and Metabolism, Tokai University Scho ol of Medicine
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 Institutional review board for clinical research, Tokai University
Address 143 Shimokasuya, Isehara, Kanagawa 2 59-1193, JAPAN
Tel 0463-93-1121
Email tokai-rinsho@ml.tokai-u.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
2018 Year 03 Month 20 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 200
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 No longer recruiting
Date of protocol fixation
2017 Year 11 Month 02 Day
Date of IRB
2017 Year 09 Month 06 Day
Anticipated trial start date
2017 Year 11 Month 02 Day
Last follow-up date
2019 Year 12 Month 31 Day
Date of closure to data entry
2019 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information No intervention, retrospective observation study.

Management information
Registered date
2018 Year 03 Month 20 Day
Last modified on
2019 Year 09 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036338

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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