UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044746 |
|---|---|
| Receipt number | R000051085 |
| Scientific Title | Development of an evaluation system for chronic kidney disease using functional MRI (magnetic resonance imaging) and machine learning |
| Date of disclosure of the study information | 2021/07/15 |
| Last modified on | 2024/07/27 19:07:55 |
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Basic information
Public title
Development of an evaluation system for chronic kidney disease using functional MRI (magnetic resonance imaging) and machine learning
Acronym
Development of an evaluation system for chronic kidney disease using functional MRI (magnetic resonance imaging) and machine learning
Scientific Title
Development of an evaluation system for chronic kidney disease using functional MRI (magnetic resonance imaging) and machine learning
Scientific Title:Acronym
Development of an evaluation system for chronic kidney disease using functional MRI (magnetic resonance imaging) and machine learning
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Diagnosis of disease, assessment of pathophysiological status, and detection of early progressors
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Annual rate of decline in estimated glomerular filtration rate
Key secondary outcomes
Estimated glomerular filtration rate, urinary protein levels and other urine and blood test results
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
A chronic kidney disease patient who underwent MRI at Saitama Medical University for the diagnosis of chronic kidney disease.
Key exclusion criteria
After the introduction of renal replacement therapy, children, acute kidney injury, unilateral kidney disease (such as renovascular hypertension), kidney tumors, nephrotic syndrome, cystic disease, and postrenal renal failure
Target sample size
300
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
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
hirookda@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Saitama Medical University
Organization
Division
Category of Funding Organization
Other
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
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
| 2021 | Year | 07 | Month | 15 | 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
300
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Due to the time required for analysis.
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 06 | Month | 07 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2021 | Year | 06 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A non-interventional, retrospective observational study. Total 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
| 2021 | Year | 07 | Month | 03 | Day |
Last modified on
| 2024 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051085
