UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007410
Receipt No. 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

* 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 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
Email 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
Email satoshi@juntendo.ac.jp

Sponsor
Institute Division of Nephrology, Juntendo University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008726

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.