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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000040424
Receipt No. R000045887
Scientific Title Renal protective effect after administration of sodium-glucose cotransporter 2 inhibitors in type 2 diabetes patients and chronic kidney disease with normoalbuminuria
Date of disclosure of the study information 2020/05/19
Last modified on 2020/05/17

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Basic information
Public title Renal protective effect after administration of sodium-glucose cotransporter 2 inhibitors in type 2 diabetes patients and chronic kidney disease with normoalbuminuria
Acronym Renal protective effect after administration of SGLT2 inhibitors in atypical DKD
Scientific Title Renal protective effect after administration of sodium-glucose cotransporter 2 inhibitors in type 2 diabetes patients and chronic kidney disease with normoalbuminuria
Scientific Title:Acronym Renal protective effect after administration of SGLT2 inhibitors in atypical DKD
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 investigate the renoprotective effects of SGLT2 inhibitor for with type 2 diabetes and CKD with normoalbuminuria
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes to assess the clinical effectiveness of SGLT2is on renal function by analyzing the change in eGFR at 1 years after initiating SGLT2 inhibitor compare with that in conventional antidiabetic medication
Key secondary outcomes to investigate the variables associated with the change in eGFR at 1 years after initiating SGLT2 inhibitor

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 Patients with type 2 diabetes and CKD (eGFR < 60 mL/min/1.73 m2) with normoalbuminurea (urine albumin to creatinine ratio (UACR) < 30 mg/g Cr and/or urinary protein to creatinine ratio (UPCR) < 150 mg/g Cr)
Key exclusion criteria 1)type 1 diabetes
2)taking glucagon-like peptide-1 receptor agonists for type 2 diabetes
3)endocrine disease
4)taking steroid or immunosuppressant for autoimmune disease
5)dialysis, transplantation
6)liver cirrhosis and malignancy
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Kiyohiko
Middle name
Last name Takahashi
Organization Obihiro-Kosei General Hospital
Division name Third Department of Internal Medicine
Zip code 080-0024
Address 1,W14,S10,Obihiro, Hokkaido
TEL 0155-65-0101
Email kiyopon19840330@yahoo.co.jp

Public contact
Name of contact person
1st name Kiyohiko
Middle name
Last name Takahashi
Organization Obihiro-Kosei General Hospital
Division name Third Department of Internal Medicine
Zip code 080-0024
Address 1,W14,S10,Obihiro, Hokkaido
TEL 0155-65-0101
Homepage URL
Email kiyopon19840330@yahoo.co.jp

Sponsor
Institute Obihiro-Kosei General Hospital
Institute
Department

Funding Source
Organization Obihiro-Kosei General Hospital
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 Obihiro-Kosei General Hospital
Address 1,W14,S10,Obihiro, Hokkaido
Tel 0155-65-0101
Email obi.rinris@ja-hokkaidoukouseiren.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
2020 Year 05 Month 19 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 46
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
2019 Year 12 Month 01 Day
Date of IRB
2020 Year 05 Month 11 Day
Anticipated trial start date
2020 Year 05 Month 11 Day
Last follow-up date
2020 Year 05 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Renal protective effect after administration of sodium-glucose cotransporter 2 inhibitors in type 2 diabetes patients and chronic kidney disease with normoalbuminuria

Management information
Registered date
2020 Year 05 Month 17 Day
Last modified on
2020 Year 05 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045887

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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