UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020166 |
|---|---|
| Receipt number | 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 | 2024/12/17 09:11:04 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
405
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
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
tmarumo-npr@umin.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
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
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
Partially published
Result
URL related to results and publications
http://dx.doi.org/10.1136/bmjdrc-2020-001501, https://journals.physiology.org/doi/abs/10.1152/ajpren
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
| 2021 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 15 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
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 2025 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
| 2024 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023224
