UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007410 |
|---|---|
| Receipt number | R000008726 |
| Scientific Title | Validation Study of New Screening Method for Micro-proteinuria using Erythrosin B |
| Date of disclosure of the study information | 2012/03/01 |
| Last modified on | 2016/03/30 09:51:11 |
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Basic information
Public title
Validation Study of New Screening Method for Micro-proteinuria using Erythrosin B
Acronym
Validation Study of Erythrosin B Method for Screening of Micro-proteinuria
Scientific Title
Validation Study of New Screening Method for Micro-proteinuria using Erythrosin B
Scientific Title:Acronym
Validation Study of Erythrosin B Method for Screening of Micro-proteinuria
Region
| Japan |
Condition
Condition
healthy volunteers, people undergoing medical check-up and patients with diabetes, hypertension or CKD
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Nephrology |
| Laboratory medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Validation of new urinary protein assay
Basic objectives2
Others
Basic objectives -Others
Comparison of sensitivity and cost effectiveness with TIA for detecting microalbuminuria and micro-proteinuria
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Sensitivity to detect microalbuminuria and micro-proteinuria
Key secondary outcomes
Relation between clinical background of subjects and micro-proteinuria
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 volunteers, people undergoing medical-check and patients with diabetes, hypertension and CKD
Key exclusion criteria
patient with high amount of proteinuria such as nephrotic syndrome
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiko Tomino |
Organization
Juntendo University
Division name
Nephrology
Zip code
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-5802-1064
yasui@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Horikoshi |
Organization
Juntendo University
Division name
Nephrology
Zip code
Address
2-1-1Hongo, Bunkyo-ku,Tokyo
TEL
03-5802-1065
Homepage URL
satoshi@juntendo.ac.jp
Sponsor or person
Institute
Division of Nephrology, Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Shino-Test Co.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2012 | Year | 03 | 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
Results
Erythrosin B method is superior to PR-Mo method and comparable to TIA in the sensitivity to albumin. This method will be useful for the diagnosis of microalbuminuria with 80% cost saving compared with TIA.
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
| 2012 | Year | 02 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
| 2013 | Year | 11 | Month | 16 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 06 | Month | 30 | Day |
Other
Other related information
Finished
Management information
Registered date
| 2012 | Year | 02 | Month | 29 | Day |
Last modified on
| 2016 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008726
