UMIN-CTR Clinical Trial

Basic information
Public title	The effect of SGLT2 inhibitor on diabetic kidney disease-Examination by MRI
Acronym	The effect of SGLT2 inhibitor on diabetic kidney disease-Examination by MRI
Scientific Title	The study on the efficacy of SGLT2 inhibitor for DKD using functional MRI
Scientific Title:Acronym	The study on the efficacy of SGLT2 inhibitor for DKD using functional MRI
Region	Japan

Condition
Condition	Diabetic Kidney Disease
Classification by specialty	Endocrinology and Metabolism Nephrology Radiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Establish the efficacy of SGLT2 inhibitor on DKD and the clinical usefulness of functional MRI in DKD evaluation by visualizing and demonstrating the ischemic improvement effect of SGLT2 inhibitor on DKD using functional MRI
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes after 24 weeks in ischemic state of kidney on functional MRI images [T2*value, apparent diffusion coefficient (ADC) value]
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	25 years-old <=
Age-upper limit	75 years-old >
Gender	Male and Female
Key inclusion criteria	Both more than eGFR 45 mL/min/1.73m2 and more than ACR 30 mg/g Cr.
Key exclusion criteria	# Less than eGFR 45 ml/min/1.73m2 # More than 100 U/L of AST or ALT (excluded patients with fatty liver) # Patients who chenged or increased oral hypoglycemic agents within the past 3 months # Pregnant or breastfeeding women # Patients who have diagnosed with malignancy within the past year # Patients who have had a cardiovascular event or stroke within the past year
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Nobuyuki Middle name Last name Koriyama
Organization	National Hospital Organization, Kagosima Medical Center
Division name	The Department of Diabetes and Endocrine Medicine
Zip code	892-0853
Address	8-1 Shiroyama-chyo, Kagosima city, Kagosima
TEL	81-099-223-1151
Email	koriyama.nobuyuki.wm@mail.hosp.go.jp

Public contact
Name of contact person	1st name Nobuyuki Middle name Last name Koriyama
Organization	National Hospital Organization, Kagosima Medical Center
Division name	The Department of Diabetes and Endocrine Medicine
Zip code	892-0853
Address	8-1 Shiroyama-chyo, Kagosima city, Kagosima
TEL	81-099-223-1151
Homepage URL
Email	koriyama.nobuyuki.wm@mail.hosp.go.jp

Sponsor
Institute	National Hospital Organization, Kagosima Medical Center
Institute
Department

Funding Source
Organization	National Hospital Organization, Kagosima Medical Center
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	National Hospital Organization, Kagosima Medical Center
Address	8-1 Shiroyama-chyo, Kagosima city, Kagosima
Tel	81-099-223-1151
Email	jogasaki.michihisa.kb@mail.hosp.go.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	2019 Year 06 Month 01 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	Terminated
Date of protocol fixation	2019 Year 04 Month 16 Day
Date of IRB	2019 Year 06 Month 06 Day
Anticipated trial start date	2019 Year 06 Month 10 Day
Last follow-up date	2021 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Oct.16/2019 1.registered 8 cases 2.Blood and urine collection before SGLT2 inhibitor administration were done with 8 cases 3.MRI before SGLT2 inhibitor administration were taken with 8 cases 4.Blood and urine collection after SGLT2 inhibitor administration were done with 3 cases 5.MRI after SGLT2 inhibitor administration were taken with 3 cases

Management information
Registered date	2019 Year 04 Month 16 Day
Last modified on	2022 Year 04 Month 27 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041588