UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048804 |
|---|---|
| Receipt number | R000054127 |
| Scientific Title | Epidemiologic study to investigate reference values of urinary protein-to-creacinin and albumin-to-creacini ratio. |
| Date of disclosure of the study information | 2022/09/01 |
| Last modified on | 2023/03/02 09:51:08 |
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Basic information
Public title
Epidemiologic study to investigate reference values of urinary protein-to-creacinin and albumin-to-creacini ratio.
Acronym
Epidemiologic study to investigate reference values of urinary protein-to-creacinin and albumin-to-creacini ratio.
Scientific Title
Epidemiologic study to investigate reference values of urinary protein-to-creacinin and albumin-to-creacini ratio.
Scientific Title:Acronym
Epidemiologic study to investigate reference values of urinary protein-to-creacinin and albumin-to-creacini ratio.
Region
| Japan |
Condition
Condition
Pediatric nephrologic disease
Classification by specialty
| Nephrology | Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the reference values of the Urinary protein-to-creatinin and albumin-to-creacinin ratio.
Basic objectives2
Others
Basic objectives -Others
Settings of reference values.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Configureing the reference values of urinary urinary protein-to-creatinin and albumin-to-creacinin ratio.
Key secondary outcomes
Configureing the reference values of urinary urinary beta2microgloblin-to-creatinin and alpha1microgloblin-to-creacinin ratio.
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
| 3 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy childre submitting urines for school urinalysis.
Key exclusion criteria
Children hoping not to join the study.
Target sample size
1600
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Matsuyama |
Organization
Fussa Hospital
Division name
Pediatrics
Zip code
197-8511
Address
1-6-1 Kamidaira Fussa Tokyo Japan
TEL
0425511111
matsuyama@fussahsp.jp
Public contact
Name of contact person
| 1st name | Shojiro |
| Middle name | |
| Last name | Okamoto |
Organization
Tokai University Hachioji Hospital
Division name
Pediatrics
Zip code
192-0032
Address
1838 Ishikawacho Hachioji Tokyo Japan
TEL
0426391111
Homepage URL
sotomakosho@ybb.ne.jp
Sponsor or person
Institute
Fussa Hospital
Institute
Department
Personal name
Funding Source
Organization
Health Research on Children, Youth and Families, Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fussa HospitalFussa Hospital
Address
1-6-1 Kamidaira Fussacity Tokyo Japan
Tel
0425511111
matsuyama@fussahsp.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 01 | 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
1712
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
To analyze the integrity of analysis and clinical observation
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
| 2013 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2013 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2022 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2022 | Year | 08 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Non-interventional observation study.
Management information
Registered date
| 2022 | Year | 08 | Month | 31 | Day |
Last modified on
| 2023 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054127
