UMIN-ICDS Clinical Trial

Public title

Research aimed at elucidating the pathophysiology of the cardiovascular-kidney-metabolic syndrome using single-cell and spatial transcriptomic analysis

Acronym

Research aimed at elucidating the pathophysiology of the CKM synd.

Scientific Title

Research aimed at elucidating the pathophysiology of the cardiovascular-kidney-metabolic syndrome using single-cell and spatial transcriptomic analysis

Scientific Title:Acronym

Research aimed at elucidating the pathophysiology of the CKM synd.

Region

Japan

Condition

Chronic kidney disease and cardiovascular-kidney-metabolic syndrome

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

In this study, single-cell and spatial transcriptomic analyses of human kidney and vascular specimens collected at our institution, as well as proteomic analyses of chronic kidney disease (CKD), will be conducted. These data will then be integrated with information from the J-Kidney-Biobank, a biobank for CKD, to elucidate the pathophysiology of CKM syndrome, and to identify novel biomarkers and therapeutic targets.

Basic objectives2

Others

Basic objectives -Others

This study will be carried out in an ethically and socially acceptable manner, with particular consideration given to ELSI (Ethical, Legal, and Social Issues) and RRI (Responsible Research and Innovation). While this research is exploratory in nature and does not presuppose specific hypotheses, the following elements will be examined based on the PECO (Population, Exposure, Comparator, Outcome) framework: in patients with chronic kidney disease, whether metabolic abnormalities and coexisting cardiovascular disease lead to changes in kidney tissue, vascular tissue, and plasma, and the nature of such changes. The outcomes of this analysis include the identification of disease-associated cells and pathways, as well as the discovery of potential biomarkers.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

As this study is exploratory in nature, no specific primary endpoint will be defined. However, to achieve the study objectives, the following items will be designated as the main analytical focus. Main analytical focus is as follows: Identification of cell populations and analysis of disease-associated pathways in kidney tissue using single-cell and spatial transcriptomic analysis, identification of disease-associated cells in vascular tissue using single-cell transcriptomic analysis, exploration of CKM syndrome-related biomarkers through plasma proteomic analysis.

Key secondary outcomes

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

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Participants in this study shall be individuals who meet all of the following criteria:

Aged 18 years or older
No restriction on sex
Meeting at least one of the following conditions:

Studies using kidney specimens:
Patients who, on or after January 1, 2020, required renal biopsy or living-donor kidney transplantation as part of routine clinical care, or who have already undergone renal biopsy or living-donor kidney transplantation. In cases of living-donor kidney transplantation, donors will also be included.

Studies using vascular specimens:
Patients who, on or after January 1, 2020, required arteriovenous fistula creation or synthetic vascular graft implantation as part of routine clinical care, or who have already undergone these procedures.

Studies using plasma specimens:
Patients who are enrolled in the J-Kidney-Biobank and whose plasma samples have been banked in the biobank.

Key exclusion criteria

Individuals meeting any of the following conditions will not be included in this study:
Cases in which the investigator determines that participation is undesirable, such as when there is a risk of compromising data reliability.
Cases involving kidney transplantation performed using deceased donors rather than living donors.
Individuals who have expressed refusal for their information to be used in this study.
Individuals who lack the capacity to provide informed consent.
Cases in which no specimens are available for analysis, for example, when no residual samples remain beyond those required for routine clinical care.

Target sample size

150

Name of lead principal investigator

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

TEL

+81-3-3815-5411

Email

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

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

TEL

+81-3-3815-5411

Homepage URL

Email

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

Institute

the University of Tokyo

Institute

Department

Personal name

Organization

Japan Agency for Medical Research and Development

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Office for Human Research Studies(OHRS), Graduate School of Medicine and Faculty of Medicine, The University of Tokyo

Address

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

Tel

+81-3-3815-5411

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

2025

Year

11

Month

27

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

2025

Year

11

Month

26

Day

Date of IRB

2025

Year

11

Month

26

Day

Anticipated trial start date

2025

Year

11

Month

28

Day

Last follow-up date

2029

Year

09

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Informed Consent
For patients scheduled for renal biopsy, living-donor kidney transplantation, arteriovenous fistula creation, or vascular graft implantation, written informed consent will be obtained during routine clinical care. In living-donor transplantation, consent will generally be obtained from the recipient; however, if information beyond age and sex is collected from the donor, consent will be obtained from both donor and recipient. For cases with previously performed procedures and available residual specimens, an opt-out opportunity will be provided, with written consent obtained when appropriate. Plasma samples from the J-Kidney-Biobank are irreversibly anonymized and will be handled through public disclosure.

Specimen Collection
Residual pathological kidney and vascular specimens remaining after clinical use will be used. Residual fresh tissue may also be analyzed when available.

Blood Samples
Conducted only with written consent. Residual blood from routine testing will be collected and frozen. DNA will be extracted only if necessary; otherwise, samples will be discarded after study completion.

Plasma Samples
Approximately 100 plasma samples from the J-Kidney-Biobank will undergo proteomic analysis, with integrated analysis of associated genomic and metabolomic data when applicable.

Clinical Data
Clinical information will be collected from medical records within six months before and after specimen collection.

Anonymization
A unique study ID will be assigned, and all data and specimens will be managed using this ID. Biobank samples are already anonymized and handled using the provided ID.

Registered date

2025

Year

11

Month

27

Day

Last modified on

2025

Year

11

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068504