UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053010 |
|---|---|
| Receipt number | R000060420 |
| Scientific Title | Exploration of Clinical Indicators of Renal Dysfunction in Japanese Adult Male and Female -A cross-sectional study |
| Date of disclosure of the study information | 2023/12/06 |
| Last modified on | 2024/06/06 09:03:52 |
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Basic information
Public title
Exploration of Clinical Indicators of Renal Dysfunction in Japanese Adult Male and Female
-A cross-sectional study
Acronym
Exploration of Clinical Indicators of Renal Dysfunction in Japanese Adult Male and Female
Scientific Title
Exploration of Clinical Indicators of Renal Dysfunction in Japanese Adult Male and Female
-A cross-sectional study
Scientific Title:Acronym
Exploration of Clinical Indicators of Renal Dysfunction in Japanese Adult Male and Female
Region
| Japan |
Condition
Condition
Normal subjects and those with reduced renal function or renal impairment
Classification by specialty
| Nephrology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Explore early biomarkers of renal dysfunction in subjects with renal function or renal impairment and normal subjects (controls)
Basic objectives2
Others
Basic objectives -Others
Data accumulation on biomarkers for early prediction of renal dysfunction
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Biomarkers of renal dysfunction, Oxidative stress markers, inflammatory markers
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subjects with renal impairment or impaired renal function
1) Japanese male and female aged 40 years or older at the time of consent.
2) Subjects with eGFRcreat < 60 ml/min/1.73 m2 or urinary albumin/Cr ratio of 30 mg/gCr or more.
Controls
1) Japanese male and female aged 40 years or older at the time of consent.
2) Subjects with no renal impairment, impaired renal function or abnormal urinalysis.
Key exclusion criteria
1) Subjects on renal dialysis or after renal transplantation.
2) Subjects with one or more diagnoses of hereditary kidney diseases, primary kidney diseases, hepatitis virus-related nephropathies or drug-induced kidney diseases.
3) Subjects with serious illnesses such as malignancy, severe heart failure, cirrhosis, chronic kidney disease or acute deterioration of complications.
4) Subjects with a history of surgery, severe infection or trauma or burns within 3 months.
5) Subjects who have changed the type or dose of a therapeutic drug affecting the study within 3 months.
6) Subjects treated with immunosuppressive drugs or steroids within 6 months
7) Subjects with symptomatic hypotension or systolic blood pressure < 90 mg
8) Subjects with type 1 diabetes mellitus or a history of severe hypoglycaemia.
9) Subjects with inborn errors of amino acid metabolism.
10) Subjects who regularly use food fortified with specified amino acids.
11) Subjects who are pregnant or lactating.
12) Subjects who have participated in other clinical trials within 1 month or will participate during this study.
13) Subjects judged as unsuitable for the study by the responsible doctor for other reasons.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Sachiyuki |
| Middle name | |
| Last name | Teramoto |
Organization
FANCL Corporation
Division name
Research Institute
Zip code
244-0806
Address
12-13, Kamisinano, Totsuka-ku, Yokohama, Kanagawa
TEL
045-820-3425
sateramoto@fancl.co.jp
Public contact
Name of contact person
| 1st name | Reiko |
| Middle name | |
| Last name | Naito |
Organization
Kenkoin Medical Corporation Foundation
Division name
Kenkoin Clinic
Zip code
104-0061
Address
6-7-4 Ginza, Chuo-ku, Tokyo, Japan
TEL
03-3573-1153
Homepage URL
reiko-naito@kenkoin.jp
Sponsor or person
Institute
FANCL Corporation
Institute
Department
Personal name
Funding Source
Organization
FANCL Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kenkoin Medical Corporation Foundation Clinical Research Ethics Committee
Address
6-7-4 Ginza, Chuo-ku, Tokyo, Japan
Tel
03-3573-1153
isamu-yanase@kenkoin.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
医療法人財団健康院 健康院クリニック
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 06 | 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
Completed
Date of protocol fixation
| 2023 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 23 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 07 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design :a cross-sectional study
Management information
Registered date
| 2023 | Year | 12 | Month | 06 | Day |
Last modified on
| 2024 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060420
