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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034609
Receipt No. R000039456
Scientific Title Assessment of early diabetic nephropathy using Functional MR imaging
Date of disclosure of the study information 2019/01/01
Last modified on 2019/04/24

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Basic information
Public title Assessment of early diabetic nephropathy using Functional MR imaging
Acronym Functional imaging of early diabetic nephropathy
Scientific Title Assessment of early diabetic nephropathy using Functional MR imaging
Scientific Title:Acronym Functional imaging of early diabetic nephropathy
Region
Japan

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

Objectives
Narrative objectives1 To assess the renal function of early stage diabetic nephropathy using functional MR imaging
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Usefulness of MR imaging to evaluate early stage diabetic nephropathy
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 diabetic nephropathy Staying still for 30 minutes to perform MR imaging
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients of diabetic nephropathy
Key exclusion criteria The patients who have renal disease other than diabetic nephropathy
Target sample size 120

Research contact person
Last name of lead principal investigator
1st name Akira
Middle name
Last name Yamamoto
Organization Kawasaki Medical School
Division name Radiology
Zip code 7010192
Address 577 Matsushima Kurashiki Okayama Japan
TEL 086-462-1111
Email jiro@med.kawasaki-m.ac.jp

Public contact
1st name of contact person
1st name Akira
Middle name
Last name Yamamoto
Organization Kawasaki Medical School
Division name Radiology
Zip code 7010192
Address 577 Matsushima Kurashiki Okayama Japan
TEL 086-462-1111
Homepage URL
Email jiro@med.kawasaki-m.ac.jp

Sponsor
Institute Depertment of Radiology Kawasaki Medical School
Institute
Department

Funding Source
Organization Kawasaki Medical School
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Kawasaki Medical School
Name of secondary funder(s)

IRB Contact (For public release)
Organization Research ethics committee of Kawasaki Medical School and Hospital
Address 577 Matsushima Kurashiki Okayama Japan
Tel 086-462-1111
Email kmsrec@med.kawasaki-m.ac.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 01 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
2018 Year 09 Month 10 Day
Date of IRB
Anticipated trial start date
2019 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 10 Month 23 Day
Last modified on
2019 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039456

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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