UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044294
Receipt number R000050596
Scientific Title Observational study using advanced analysis technology to understand the biological function of renal constituent cells
Date of disclosure of the study information 2021/05/31
Last modified on 2023/05/24 15:08:22

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Basic information

Public title

Observational study using advanced analysis technology to understand the biological function of renal constituent cells

Acronym

renal constituent cells study using advanced analysis technology

Scientific Title

Observational study using advanced analysis technology to understand the biological function of renal constituent cells

Scientific Title:Acronym

renal constituent cells study using advanced analysis technology

Region

Japan


Condition

Condition

CKD

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose is to build a foundation for understanding the cell functions that make up the kidney and the biological understanding of renal diseases.

Basic objectives2

Others

Basic objectives -Others

Single-cell transcriptome analysis and spatial transcriptome analysis of human kidney constituent cells will be performed, and the relationship between the gene expression profile of human kidney constituent cells and clinical parameters will be analyzed.

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Evaluate the association between gene expression profiles and renal function parameters for each human renal constituent cell

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

20 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

1) nephrectomy patients at Kitasato University Hospital between June 1, 2021 and June 30, 2022.
2) provided written informed consent

Key exclusion criteria

1) Request to refuse participation from the person or agents
2) hemodialysis patients
3) patients with HBV, HCV and HIV

Target sample size

50


Research contact person

Name of lead principal investigator

1st name SHOKICHI
Middle name
Last name NAITO

Organization

Kitasato University, School of Medicine

Division name

Nephrology

Zip code

252-0374

Address

1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, Japan

TEL

042-778-8111

Email

snaito@med.kitasato-u.ac.jp


Public contact

Name of contact person

1st name SHOKICHI
Middle name
Last name NAITO

Organization

Kitasato University, School of Medicine

Division name

Nephrology

Zip code

252-0374

Address

1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, Japan

TEL

042-778-8111

Homepage URL


Email

snaito@med.kitasato-u.ac.jp


Sponsor or person

Institute

Kitasato University, School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Kyowa Kirin Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor

Kyowa Kirin Co.,Ltd.

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kitasato University Medical Ethics Organization (KMEO)

Address

1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, Japan

Tel

042-778-8273

Email

snaito@med.kitasato-u.ac.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

2020_033_00

Org. issuing International ID_1

Kyowa Kirin Co.,Ltd. Ethics Committee

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 05 Month 31 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

50

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

2021 Year 01 Month 29 Day

Date of IRB

2021 Year 01 Month 29 Day

Anticipated trial start date

2021 Year 06 Month 01 Day

Last follow-up date

2025 Year 06 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

design: Cross-sectional study


Management information

Registered date

2021 Year 05 Month 22 Day

Last modified on

2023 Year 05 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050596


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name