UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036523
Receipt No. R000041588
Scientific Title The study on the efficacy of SGLT2 inhibitor for DKD using functional MRI
Date of disclosure of the study information 2019/06/01
Last modified on 2019/04/16

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 koriyama.nobuyuki.wm@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 Preinitiation
Date of protocol fixation
2019 Year 04 Month 16 Day
Date of IRB
Anticipated trial start date
2019 Year 06 Month 01 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

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


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.