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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000013423
Receipt No. R000015677
Scientific Title Study of the association of urinary nephrin with renal diseases
Date of disclosure of the study information 2014/03/14
Last modified on 2014/03/14

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Basic information
Public title Study of the association of urinary nephrin with renal diseases
Acronym Study of the association of urinary nephrin with renal diseases
Scientific Title Study of the association of urinary nephrin with renal diseases
Scientific Title:Acronym Study of the association of urinary nephrin with renal diseases
Region
Japan

Condition
Condition renl disease
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Elucidation of the mechanism and development of newly biomarker of renal diseases
Basic objectives2 Others
Basic objectives -Others examination for searching biomarker
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the relationship between renal disease activity and inflamation marker,such as urinary nephrin
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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who underwent renal biopsy to make a diagnosis of urinary abnormality and/or renal dysfunction
Key exclusion criteria Patients who did not undergo renal biopsy
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinji Kitamura
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Medicine and Clinical Science
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama, Okayama
TEL 086-235-7235
Email s-kita@md.okayama-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akiko Inoue
Organization Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Medicine and Clinical Science
Zip code
Address 2-5-1 Shikata-cho, Kita-ku, Okayama, Okayama
TEL 086-235-7235
Homepage URL
Email p7pm9tlb@s.okayama-u.ac.jp

Sponsor
Institute Department of Medicine and Clinical Science, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

Funding Source
Organization None
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
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
2014 Year 03 Month 14 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 No longer recruiting
Date of protocol fixation
2010 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The subjects in this study were 41 patients admitted to the Renal Unit of Okayama University Hospital and underwent renal biopsies.
The relationships between and urinary nephrin and the clinical parameters were determined.

Management information
Registered date
2014 Year 03 Month 14 Day
Last modified on
2014 Year 03 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015677

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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