UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036523 |
|---|---|
| Receipt number | 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 | 2022/04/27 17:29:46 |
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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
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
koriyama.nobuyuki.wm@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization, Kagosima Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
