UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012136
Receipt number 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 2022/05/05 09:06:34

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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 or person

Institute

Hokkaido University Graduate School of Medicine

Institute

Department

Personal name



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

2022 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

2022 Year 05 Month 05 Day



Link to view the page

Value
https://center6.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