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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029975
Receipt No. R000034211
Scientific Title Effect of SGLT2 inhibitor (Lusefi) on diabetic nephropathy Stratified analysis based on different original renal function category
Date of disclosure of the study information 2018/01/04
Last modified on 2017/11/15

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Basic information
Public title Effect of SGLT2 inhibitor (Lusefi) on diabetic nephropathy
Stratified analysis based on different original renal function category
Acronym CHAT-Lu
Scientific Title Effect of SGLT2 inhibitor (Lusefi) on diabetic nephropathy
Stratified analysis based on different original renal function category
Scientific Title:Acronym CHAT-Lu
Region
Japan

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

Objectives
Narrative objectives1 Long term time course effect of SGLT2 inhibitor (Lusefi) on renal function (eGFR)
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Renal function at 104th week post SGLT2 inhibitor treatment
Stratified analysis based on different original renal function category
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oral treatment of SGLT2 inhibitor(Lusefi)2.5mg once a day for 104 weeks
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 mellitus(HbA1c 6.5%<=)
pre eGFR(30-90ml/min/1.73m2)
age 20 years old <=
Key exclusion criteria past use of SGLT2 inhibitor
severe ketoacidosis,diabetes coma,type1diabetes
severe infection,pre and post operation,severe in injury
pregnancy,lactation,potential pregnancy
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hidenori Urata
Organization Fukuoka University Chikushi Hospital
Division name Cardiovascular internal medicine
Zip code
Address 1-1-1,Zokumyoin,Chikushino Fukuoka
TEL 092-921-1011
Email uratah@fukuoka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hidenori Urata
Organization Fukuoka University Chikushi Hospital
Division name Cardiovascular internal medicine
Zip code
Address 1-1-1,Zokumyoin,Chikushino Fukuoka
TEL 092-921-1011
Homepage URL
Email uratah@fukuoka-u.ac.jp

Sponsor
Institute Fukuoka University Chikushi Hospital
Institute
Department

Funding Source
Organization Tisho Toyama Pharmaceutical co,Ltd
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
2018 Year 01 Month 04 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 Preinitiation
Date of protocol fixation
2017 Year 06 Month 15 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 11 Month 15 Day
Last modified on
2017 Year 11 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034211

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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