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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000020166
Receipt No. R000023224
Scientific Title Relationship between kidney disease and epigenome information of the kidney and urine
Date of disclosure of the study information 2015/12/11
Last modified on 2020/06/14

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Basic information
Public title Relationship between kidney disease and epigenome information of the kidney and urine
Acronym Kidney disease and epigenome
Scientific Title Relationship between kidney disease and epigenome information of the kidney and urine
Scientific Title:Acronym Kidney disease and epigenome
Region
Japan

Condition
Condition Healthy volunteer, patients with kidney and urinary tract tumor, kidney disease, hypertension, diabetes, dyslipidemia, cardiovascular disease, and current smoker.
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the association of DNA methylation level in the kidney, urine, blood, and cells from urinary tract system with risk factors of kidney disease such as proteinuria, eGFR, hypertension, diabetes, and dyslipidemia to determine whether DNA methylation level is a useful marker of kidney disease.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes (1) The association between DNA methylation level and risk factors of kidney disease.
(2) The association between DNA methylation level and the prognosis of kidney disease.
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

Not applicable
Gender Male and Female
Key inclusion criteria Healthy volunteer, patients with kidney and urinary tract tumor, kidney disease, hypertension, diabetes, dyslipidemia, cardiovascular disease and current smoker.
Key exclusion criteria Patients who are considered not eligible for the study by the attending doctor.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Takeshi
Middle name
Last name Marumo
Organization International University of Health and Welfare
Division name School of Medicine
Zip code 286-8686
Address 4-3 Kouzunomori, Narita-shi, Chiba, 286-8686, JAPAN
TEL 0476-20-7701
Email tmarumo-npr@umin.ac.jp

Public contact
Name of contact person
1st name Takeshi
Middle name
Last name Marumo
Organization International University of Health and Welfare
Division name School of Medicine
Zip code 286-8686
Address 4-3 Kouzunomori, Narita-shi, Chiba, 286-8686, JAPAN
TEL 0476-20-7701
Homepage URL
Email tmarumo-npr@umin.ac.jp

Sponsor
Institute International University of Health and Welfare
Institute
Department

Funding Source
Organization International University of Health and Welfare
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Administrative Office of the Ethics Review Board, School of Medicine, IUHW
Address 4-3 Kouzunomori, Narita-shi, Chiba 286-8686, Japan
Tel 0476-20-7708
Email rinri_md@iuhw.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 国際医療福祉大学医学部、東京大学医学部附属病院、虎の門病院、国際医療福祉大学三田病院、永寿総合病院、慶應義塾大学、帝京大学医学部

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 11 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
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 Enrolling by invitation
Date of protocol fixation
2014 Year 10 Month 30 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 15 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information (1)Cross-sectional study
(2)We enroll subjects who visit our institutions from January 2015 to December 2020 and meet the inclusion criteria.
(3)We measure DNA methylation level, serum Cr, eGFR, blood lipid profile, blood glucose and HbA1c levels, urinary protein and albumin excretion levels, urinary NAG, and blood pressure.

Management information
Registered date
2015 Year 12 Month 11 Day
Last modified on
2020 Year 06 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023224

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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