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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035263
Receipt No. R000040173
Scientific Title Study for the effect of SGLT2 inhibitors in high risk patients of dialysis with type 2 diabetes
Date of disclosure of the study information 2018/12/15
Last modified on 2019/07/10

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Basic information
Public title Study for the effect of SGLT2 inhibitors in high risk patients of dialysis with type 2 diabetes
Acronym The effect of SGLT2 inhibitors in patients with renal dysfunction
Scientific Title Study for the effect of SGLT2 inhibitors in high risk patients of dialysis with type 2 diabetes
Scientific Title:Acronym The effect of SGLT2 inhibitors in patients with renal dysfunction
Region
Japan

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

Objectives
Narrative objectives1 To assess the effects of SGLT2 inhibitors on preventing the progression of eGFR decline in patients with type 2 diabetes.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase IV

Assessment
Primary outcomes Change in eGFR decline rate between before and after 2 years of SGLT2 inhibitors administration
Key secondary outcomes Glycemic control
Weight
Blood pressure
Blood and Urine test (Liver, Kidney function, lipid, UA)
Characteristics of patients who well responded to SGLT2 inhibitors
Comparison of eGFR decline change with that in non-SGLT2 inhibitors users who were matched background

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Continuing SGLT2 inhibitors concomitant with diet therapy for more than 2 years
2) eGFR < 60ml/min/1.73m2 at starting SGLT2 inhibitors
3) There are eGFR data for more than 2 years both before and after starting SGLT2 inhibitors
Key exclusion criteria 1) type 1 diabetes
2) severe liver dysfunction
3) pregnancy, nursing woman or possibly pregnant woman
4) severe diabetic ketosis, diabetic coma
5) severe infection, pre and post operation
, severe trauma
7) uncontrolled diet therapy
8) poor adherence for medication
9) patients who thought to be inappropriate to enter this study for some reasons by physician's judgments
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshio Kurihara
Organization Kurihara Naika Clinic
Division name Internal Medicine
Zip code
Address 7-28,3-jo 5-chome, Atsubetsu-Chuo, Atsubetsu-ku, Sapporo, Hokkaido, Japan
TEL 011-892-3522
Email ykuri@yg7.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshio Kurihara
Organization Kurihara Naika Clinic
Division name Internal Medicine
Zip code
Address 7-28,3-jo 5-chome, Atsubetsu-Chuo, Atsubetsu-ku, Sapporo, Hokkaido, Japan
TEL 011-892-3522
Homepage URL
Email ykuri@yg7.so-net.ne.jp

Sponsor
Institute Kurihara Naika Clinic
Institute
Department

Funding Source
Organization Kurihara Naika Clinic
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
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 12 Month 15 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 Completed
Date of protocol fixation
2018 Year 10 Month 20 Day
Date of IRB
2018 Year 10 Month 20 Day
Anticipated trial start date
2018 Year 12 Month 20 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information retrospective cohort study to assess the effects of SGLT2 inhibitors on preventing the progression of eGFR decline (%delta eGFR2years) in patients with type 2 diabetes

Management information
Registered date
2018 Year 12 Month 14 Day
Last modified on
2019 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040173

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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