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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000012136
Receipt No. R000014190
Scientific Title Pathological analysis of activated glomerular parietal epithelial cells in children
Date of disclosure of the study information 2013/10/28
Last modified on 2020/05/04

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Basic information
Public title Pathological analysis of activated glomerular parietal epithelial cells in children
Acronym Pathological analysis of activated glomerular parietal epithelial cells in children
Scientific Title Pathological analysis of activated glomerular parietal epithelial cells in children
Scientific Title:Acronym Pathological analysis of activated glomerular parietal epithelial cells in children
Region
Japan

Condition
Condition Pediatric renal disease
Classification by specialty
Nephrology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the role of CD44 positive glomerular parietal epithelial cells in children with renal disease
Basic objectives2 Others
Basic objectives -Others To clarify the physiology of glomerulosclerosis
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes renal impairment, proteinuria, hypertension
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

Not applicable
Age-upper limit
20 years-old >=
Gender Male and Female
Key inclusion criteria 1) Age to 20 years
2) Renal biopsy has been performed for diagnosis pediatric renal disease
3) Written informed consent from patient's parents or legal guardians.
Key exclusion criteria 1) All specimen was necessary for diagnosis renal disease.
2) Judged inappropriate for this study by the physicians.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Takayuki
Middle name
Last name Okamoto
Organization Hokkaido University Graduate School of Medicine
Division name Department of Pediatrics
Zip code 060-8638
Address North 15, West 7, Kita-Ku, Sapporo
TEL +81-11-706-5954
Email okamon@med.hokudai.ac.jp

Public contact
Name of contact person
1st name Takayuki
Middle name
Last name Okamoto
Organization Hokkaido University Graduate School of Medicine
Division name Department of Pediatrics
Zip code 060-8638
Address North 15, West 7, Kita-Ku, Sapporo
TEL +81-11-706-5954
Homepage URL
Email okamon@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Hokkaido University Hospital Clinical Research and Medical Innovation Center
Address North 14, West 5, Kita-Ku, Sapporo
Tel 011-706-7061
Email crjimu@huhp.hokudai.ac.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
2013 Year 10 Month 28 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 Enrolling by invitation
Date of protocol fixation
2013 Year 10 Month 01 Day
Date of IRB
2013 Year 10 Month 23 Day
Anticipated trial start date
2013 Year 10 Month 30 Day
Last follow-up date
2027 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information To clarify the association between the expression of activated parietal epithelial cells and clinical manifestations in children with renal disease.

Management information
Registered date
2013 Year 10 Month 28 Day
Last modified on
2020 Year 05 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014190

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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