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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000037310
Receipt No. R000042459
Scientific Title Construction of an AI assessment system for the risk of CKD progression using renal functional MRI data
Date of disclosure of the study information 2019/08/01
Last modified on 2020/01/18

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Basic information
Public title Development of an assessment method for the risk of progression in chronic kidney disease using MRI (magnetic resonance imaging) and artificial intelligence.
Acronym Development of an assessment method for the risk of progression in chronic kidney disease using MRI (magnetic resonance imaging) and artificial intelligence.
Scientific Title Construction of an AI assessment system for the risk of CKD progression using renal functional MRI data
Scientific Title:Acronym Construction of an AI assessment system for the risk of CKD progression using renal functional MRI data
Region
Japan

Condition
Condition chronic kidney disease
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Detection of early progression
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Decreases in estimated glomerular filtration rate
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria An adult chronic kidney disease patient without any MRI contraindications who regular visits the participating hospital.
Key exclusion criteria After the introduction of renal replacement therapy, MRI contraindications, children, acute kidney injury, unilateral kidney disease (such as renovascular hypertension), kidney tumors, nephrotic syndrome, cystic disease, and postrenal renal failure
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Hirokazu
Middle name
Last name Okada
Organization Saitama Medical University
Division name Department of Nephrology
Zip code 350-0495
Address 38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, Japan
TEL 0492761611
Email hirookda@saitama-med.ac.jp

Public contact
Name of contact person
1st name Hirokazu
Middle name
Last name Okada
Organization Saitama Medical University
Division name Department of Nephrology
Zip code 350-0495
Address 38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, Japan
TEL 0492761611
Homepage URL
Email hirookda@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Saitama Medical University
Address 38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, Japan
Tel 0492761354
Email hirb@saitama-med.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 08 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 Enrolling by invitation
Date of protocol fixation
2019 Year 07 Month 01 Day
Date of IRB
2019 Year 07 Month 01 Day
Anticipated trial start date
2019 Year 08 Month 01 Day
Last follow-up date
2021 Year 03 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A non-interventional, past-starting point prospective (observational) study. Random sampling for cases meeting the inclusion criteria. To examine the relationship between MRI, clinical data (blood and urine test), and annual changes in estimated glomerular filtration rate.

Management information
Registered date
2019 Year 07 Month 08 Day
Last modified on
2020 Year 01 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042459

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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