UMIN-ICDS Clinical Trial

Public title

A Pilot Study on Web-Based Telemedicine Consultations for the Diagnosis and Treatment of Kidney Diseases, with a Focus on Designated Intractable Diseases

Acronym

Remote Consultation Network for Kidney Disease (Kidney Bridge)

Scientific Title

A Pilot Study on Web-Based Telemedicine Consultations for the Diagnosis and Treatment of Kidney Diseases, with a Focus on Designated Intractable Diseases

Scientific Title:Acronym

Remote Consultation Network for Kidney Disease (Kidney Bridge)

Region

Japan

Condition

kidney disease

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Chronic kidney disease (CKD) and other renal disorders comprise a wide range of conditions, including designated intractable diseases, and their diagnosis and treatment require a high level of specialized expertise. Kidney specialists tend to be concentrated in major urban hospitals, and access to specialized care and renal pathology diagnosis is particularly limited in rural areas and regions facing physician shortages.

In its Second Five-Year Plan formulated in 2022, the Japanese Society of Nephrology emphasized the development and implementation of support systems for underserved regions through telemedicine and related services. Advances in ICT technologies have further expanded the potential for remote case consultations and the sharing of pathological images.

This study aims to reduce disparities in medical care caused by regional imbalances in the availability of nephrology specialists and renal pathology diagnostic systems. To achieve this, we will develop a remote consultation framework and evaluate its usefulness and feasibility for real-world implementation.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

Satisfaction with answers (5-point scale): Calculation of median (IQR).

System usefulness: Descriptive statistics of a 5-point scale.

Educational and clinical decision support effects (5-point scale): Calculation of median (IQR).

Clinical utility: Multiple-choice data will be collected immediately after receiving answers regarding the intended management plan (e.g., "plan to perform additional tests," "consider referral to a specialist," "maintain current plan," "change treatment plan," "information gathering only") and 1 month later regarding actual clinical implementation. The distribution (count and percentage) for each option will be analyzed using descriptive statistics.

Key secondary outcomes

Number of questions, participating medical institutions, and participating physicians: Descriptive statistics.

Inter-rater agreement among specialists' answers: Calculated using Kappa coefficients or equivalent metrics.

Time required for answer preparation and average turnaround time to submission: Mean and standard deviation (SD).

Presence or absence of references appended.

Answerability of question content.

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Inclusion Criteria for Questioners
Subjects must meet all of the following:
Status: Physicians practicing in Japan (self-reported; verified via checkbox at informed consent).
Consent: Received study explanation and provided appropriate consent.
Registration: Completed registration after email verification.

Note: Strict credential verification is difficult due to system nature. To prevent non-physician access, the form (URL/QR code) will not be public and will only be shared via:Staff areas in certified facilities (e.g., Japanese Society of Internal Medicine), physician-only websites and the Japan Kidney Association CKD Committee network.

2. Inclusion Criteria for Responders
Physicians must meet all of the following:
Qualifications: Board-certified nephrologists (JSN), board-certified pathologists (JSP), or physicians with equivalent expertise.
Consent: Received study explanation and provided informed consent.
Registration: Completed registration after email verification.

3. Inclusion Criteria for Patients (Pathological Consultation)
Patients must meet all of the following:Target:
Requiring consultation utilizing pathological images.
Consent: Received the URL/QR code from their physician, reviewed the study webpage, and provided informed consent.
Age: Being 18 years of age or older at the time of providing consent.

Note on Roles
An individual may act as both a questioner and a responder, but cannot answer their own questions.

Key exclusion criteria

Exclusion Criteria

Individuals who meet any of the following criteria will be excluded from the study or the data analysis.

Investigator's Discretion: Anyone judged by the investigator to be unsuitable for participation in this study.

No Active Participation (Exclusion from Analysis): Questioners who do not post any inquiries regarding renal disease care during the study period (these individuals will be excluded from the data analysis).

Target sample size

5430

Name of lead principal investigator

1st name	Masaomi
Middle name
Last name	Nangaku

Organization

Graduate School of Medicine, The University of Tokyo

Division name

Division of Nephrology and Endocrinology

Zip code

1138655

Address

7-3-1,Hongo, Bunkyo-ku, Tokyo, Japan

TEL

03-3815-5411

Email

jinnai.research.assist@gmail.com

Name of contact person

1st name	Yuka
Middle name
Last name	Sugawara

Organization

the University of Tokyo Hospital

Division name

Division of Nephrology and Endocrinology

Zip code

1138655

Address

7-3-1,Hongo, Bunkyo-ku, Tokyo, Japan

TEL

03-5800-8969

Homepage URL

Email

ysuga-tky@m.u-tokyo.ac.jp

Institute

The University of Tokyo

Institute

Department

Personal name

Organization

Ministry of Health, Labour, and Welfare

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Research Ethics Committee of the Faculty of Medicine of the University of Tokyo

Address

7-3-1,Hongo, Bunkyo-ku, Tokyo, Japan

Tel

03-5841-0818

Email

ethics@m.u-tokyo.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

07

Month

17

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

06

Month

17

Day

Date of IRB

2026

Year

07

Month

14

Day

Anticipated trial start date

2026

Year

07

Month

27

Day

Last follow-up date

2027

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Overview: Regional physicians submit nephrology questions (kidney disease diagnosis/treatment, renal pathology) via web form; designated specialists respond through a telemedicine system.
Questioners: Learn of study via facility/society outreach. After consent and email verification, enter attributes (experience, specialty, facility size) and post de-identified questions. Pathology cases require separate patient consent, a study ID, and slide/image submission to the study office. Complete satisfaction surveys after receiving answers.
Respondents: After consent/verification, register credentials (name, affiliation, JSN membership, experience, specialty); JSN office confirms qualification. Upon assignment, submit free-text answers plus structured items (testing recommendations, referral, guideline citations) and self-assessment surveys. Responses reach questioners anonymized; compensation provided.
Pathology patients: Consent via URL/QR code; slides/images sent to office, digitized, shared with respondent, then returned to questioner. Treatment decisions remain with the questioner.
Study office: Recruits specialists via JSN and related societies to build a candidate list; solicits questions via advertising. Screens posts for personal information, inappropriate content, or non-physician origin, deleting as needed. Digitizes pathology slides if needed. Assigns about 3 respondents per question (max 8 per respondent), requesting literature citations; reassigns on decline. Only assigned respondents view question details. Notifies questioners of responses, clarifying these are reference opinions only, with final responsibility resting with the questioner and no attending-physician liability for respondents. Aggregates and analyzes de-identified data.
Discontinuation: Halted on serious security issues or if the PI deems continuation infeasible. Deletion requests are handled individually by the office, with PI approval.

Registered date

2026

Year

07

Month

14

Day

Last modified on

2026

Year

07

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071001