UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037310
Receipt number 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 2021/07/12 14:45:38

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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 or person

Institute

Saitama Medical University

Institute

Department

Personal name



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

103

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

No longer recruiting

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

2021 Year 07 Month 12 Day



Link to view the page

Value
https://center6.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